Page last updated: 2024-12-06

fludarabine phosphate

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Description

Fludarabine phosphate is a purine nucleoside analog that is used as a chemotherapy agent. It is a prodrug that is converted to fludarabine, an inhibitor of DNA polymerase, ribonucleotide reductase, and DNA ligase. Fludarabine phosphate has been shown to be effective in the treatment of various hematologic malignancies, including chronic lymphocytic leukemia, acute lymphoblastic leukemia, and hairy cell leukemia. Its synthesis involves a multi-step process that begins with the modification of the purine base adenine. The resulting compound is then reacted with a phosphorus-containing group to form fludarabine phosphate. Fludarabine phosphate's importance lies in its ability to selectively target and kill rapidly dividing cancer cells while sparing normal cells. This selective cytotoxicity is due to its mechanism of action, which involves the inhibition of DNA synthesis and repair. Fludarabine phosphate is studied extensively to understand its efficacy and safety profile in various cancer types. Research efforts focus on optimizing its dosage, investigating its combination with other therapies, and exploring its potential for the treatment of other malignancies.'

fludarabine phosphate: structure given in first source [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

fludarabine phosphate : A purine arabinonucleoside monophosphate having 2-fluoroadenine as the nucleobase. A prodrug, it is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. Once incorporated into DNA, 2-fluoro-ara-ATP functions as a DNA chain terminator. It is used for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to, or whose disease has progressed during, treatment with at least one standard alkylating-agent containing regimenas. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID30751
CHEMBL ID1096882
CHEBI ID63599
SCHEMBL ID3511
MeSH IDM0125188

Synonyms (105)

Synonym
HY-B0028
fludarabine (phosphate)
SRI-5907-04
2-f-ara-amp
2-fluoro-ara-amp
sht-586
beneflur
oforta
2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-9h-purin-6-amine
nsc-312887
nsc312887
9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-.beta.-d-arabinofuranosyl)-
75607-67-9
fludarabine phosphate
9 beta-d-arabinofuranosyl-2-fluoroadenine monophosphate
9-beta-d-arabinofuranosyl-2-fluoroadenine 5'-(dihydrogen phosphate)
famp
fluoro-ara-amp
9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-beta-d-arabinofuranosyl)-
fludarabine 5'-monophosphate
nsc 328002
9-beta-d-arabinofuranosyl-2-fluoroadenine 5'-monophosphate
9-beta-arabinofuranosyl-2-fluoroadenine-5'-phosphate
2-fluoro-ara amp
fludarabine monophosphate
nsc 312887
faraamp
2-fluoroadenine arabinoside 5'-monophosphate
f-ara-amp
nsc-328002
fludarabine phosphate (jan/usp)
fludara (tn)
D01907
HMS2094O11
chebi:63599 ,
CHEMBL1096882
[(2r,3s,4s,5r)-5-(6-amino-2-fluoropurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl dihydrogen phosphate
A838460
9-bata-d-arabinofuranosyl-2-fluoroadenine phosphate
nsc759194
nsc-759194
pharmakon1600-01505705
MLS004774150
fludarabine phosphate [usan:usp:ban]
unii-1x9vk9o1sc
1x9vk9o1sc ,
BCP9000694
smr002544683
BCP0726000268
MLS003915617
fludarabine phosphate(fludara)
2f-ara-amp
fludarabine phosphate [usp-rs]
fludarabine phosphate [vandf]
fludarabine phosphate [orange book]
fludarabine phosphate [usp monograph]
fludarabine 5'-monophosphate [mi]
fludarabine phosphate [usan]
9-.beta.-d-arabinofuranosyl-2-fluoroadenine 5'-(dihydrogen phosphate)
fludarabine phosphate [mart.]
fludarabine phosphate [who-dd]
fludarabine phosphate [jan]
fludarabine phosphate [ep monograph]
CS-0861
S1229
HG1010
GIUYCYHIANZCFB-FJFJXFQQSA-N
CCG-213521
SCHEMBL3511
fludarabine phosphate (fludara)
((2r,3s,4s,5r)-5-(6-amino-2-fluoro-9h-purin-9-yl)-3,4-dihydroxytetrahydrofuran-2-yl)methyl dihydrogen phosphate
AKOS024464516
fludarabine phosphate;
SRI-5907_07
SRI-5907_05
mfcd00866418
DTXSID2023060 ,
9-beta-d-arabinofuranosyl-2-fluoroadenine-5'-monophosphate
{[(2r,3s,4s,5r)-5-(6-amino-2-fluoro-9h-purin-9-yl)-3,4-dihydroxyoxolan-2-yl]methoxy}phosphonic acid
sr-05000001945
SR-05000001945-4
f-ara-a (nsc 312887) phosphate
fludara phosphate
nsc 312887 phosphate
SR-05000001945-1
SBI-0206893.P001
Z2235802254
SW218146-2
bdbm50248004
AS-14202
Q185916
fludarabine-phosphate
EX-A2028
75607-67-9 (phosphate)
9h-purin-6-amine, 2-fluoro-9-(5-o-phosphono-b-d-arabinofuranosyl)-
EN300-269343
fludarabine for system suitability
[rac-(2r,3s,4s,5r)-5-(6-amino-2-fluoro-purin-9-yl)-3,4-dihydroxy-tetrahydrofuran-2-yl]methyl dihydrogen phosphate
fludarabine phosphate; 2-fluoro-9-(5-o-phosphono-?-d-arabinofuranosyl)-9h-purin-6-amine
fludarabine phosphate (usp-rs)
fludarabine phosphate (mart.)
fludarabine phosphate (usan:usp:ban)
dtxcid103060
fludarabine phosphate (usp monograph)
fludarabine phosphate (ep monograph)

Research Excerpts

Overview

Fludarabine phosphate is a purine analogue, which is known to cause immunosuppression and long-lasting T-cell lymphopenia. It is commonly employed in the therapy of hematological malignancies and non-myeloablative stem cell transplantation conditioning regimens.

ExcerptReferenceRelevance
"Fludarabine Phosphate is a commercial chemotherapy drug used in cancer treatment, and has ability to kill various cancer cells."( Using Gold Nanoparticles as Delivery Vehicles for Targeted Delivery of Chemotherapy Drug Fludarabine Phosphate to Treat Hematological Cancers.
Chen, J; Hao, Y; Patra, P; Song, S; Yang, X, 2016
)
1.38
"Fludarabine phosphate is a purine analogue, which is known to cause immunosuppression and long-lasting T-cell lymphopenia it is commonly employed in the therapy of hematological malignancies and non-myeloablative stem cell transplantation conditioning regimens."( Fludarabine phosphate may be useful in the treatment of graft-versus-host disease.
Abali, H; Aksoy, S; Dinçer, M; Erman, M; Kilickap, S, 2005
)
2.49
"Fludarabine phosphate is a purine antimetabolite approved for use in the management of patients with chronic lymphocytic leukemia. "( Fludarabine phosphate. A new anticancer drug with significant activity in patients with chronic lymphocytic leukemia and in patients with lymphoma.
Rodriguez, G, 1994
)
3.17
"Fludarabine phosphate (2-F-ara-AMP) is an adenine nucleoside analogue that shows significant activity against chronic lymphocytic leukemia and indolent lymphoma. "( In vitro cytotoxic effects of fludarabine (2-F-ara-A) in combination with commonly used antileukemic agents by isobologram analysis.
Akutsu, M; Bai, L; Furukawa, Y; Ichikawa, A; Kano, Y; Kon, K; Suzuki, K; Tsunoda, S, 2000
)
1.75
"(fludarabine phosphate) is a purine analogue that has been synthesized and found to have activity in lymphoid neoplasms in phase I and II studies."( Fludarabine phosphate in the treatment of chronic lymphocytic leukemia.
Keating, MJ, 1990
)
2.34
"(fludarabine phosphate) is a purine analogue with a high level of activity in a variety of indolent lymphoproliferative malignancies, including chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin's lymphomas (NHL), cutaneous T-cell lymphoma, macroglobulinemia, and hairy-cell leukemia."( Issues for the future development of fludarabine phosphate.
Cheson, BD, 1990
)
1.17
"Fludarabine phosphate is a nucleotide analogue of adenine arabinoside with antitumor activity in murine and human lymphoid malignancies; it has occasional, unpredictable neurotoxicity after high dose bolus injections in adults. "( Pharmacology of fludarabine phosphate after a phase I/II trial by a loading bolus and continuous infusion in pediatric patients.
Avramis, VI; Champagne, J; Ettinger, LJ; Finkelstein, J; Hammond, GD; Holcenberg, JS; Krailo, M; Poplack, DG; Reaman, G; Sato, J, 1990
)
2.07
"Fludarabine phosphate is a derivative of adenosine arabinoside. "( Phase I study of fludarabine (2-fluoro-ara-AMP).
Bodey, GP; Kavanagh, JJ; Krakoff, IH, 1985
)
1.71
"Fludarabine phosphate is a synthetic analog of beta-arabinofuranosyl adenine (beta-ara-A), an anti-viral agent. "( The potentiation of radiation response on murine tumor by fludarabine phosphate.
Alfieri, AA; Fuks, Z; Kim, JH; Kim, SH, 1986
)
1.96

Effects

Oral fludarabine phosphate has a similar clinical efficacy and safety profile to the IV formulation. It has significant activity in follicular lymphoma and in B-cell chronic lymphatic leukemia, where it has demonstrated high complete response (CR) rates.

ExcerptReferenceRelevance
"Oral fludarabine phosphate has a similar clinical efficacy and safety profile to the IV formulation."( Efficacy and safety of oral fludarabine phosphate in previously untreated patients with chronic lymphocytic leukemia.
Berthou, C; Bron, D; de Boeck, K; Deconinck, E; Foussard, C; Guibon, O; Johnson, SA; Kramer, MH; Lister, TA; Littlewood, TJ; Marcus, RE; Montillo, M; Rossi, JF; Tollerfield, SM; van Hoof, A, 2004
)
1.07
"Oral fludarabine phosphate has a similar clinical efficacy and safety profile to the IV formulation."( Efficacy and safety of oral fludarabine phosphate in previously untreated patients with chronic lymphocytic leukemia.
Berthou, C; Bron, D; de Boeck, K; Deconinck, E; Foussard, C; Guibon, O; Johnson, SA; Kramer, MH; Lister, TA; Littlewood, TJ; Marcus, RE; Montillo, M; Rossi, JF; Tollerfield, SM; van Hoof, A, 2004
)
1.07
"Fludarabine phosphate (FDR) has demonstrated a remarkable clinical activity in chronic lymphocytic leukemia (CLL). "( Autoimmune thrombocytopenia after six cycles of fludarabine phosphate in a patient with chronic lymphocytic leukemia.
Alcaraz, L; Bay, JO; Béal, D; Chollet, P; Cure, H; Fouassier, M; Plagne, R; Travade, P, 1997
)
2
"Fludarabine phosphate (F-AMP) has significant activity in follicular lymphoma and in B-cell chronic lymphatic leukemia, where it has demonstrated high complete response (CR) rates. "( Multicenter phase II study of fludarabine phosphate for patients with newly diagnosed lymphoplasmacytoid lymphoma, Waldenström's macroglobulinemia, and mantle-cell lymphoma.
Barbui, T; Coiffier, B; Foran, JM; Hiddemann, W; Johnson, SA; Lister, TA; Norton, AJ; Radford, JA; Rohatiner, AZ; Tollerfield, SM; Wilson, MP, 1999
)
2.03
"Fludarabine phosphate has substantial activity against lymphoid malignancies, particularly chronic lymphocytic leukemia (CLL) and low-grade non-Hodgkin's lymphoma (NHL)."( Fludarabine phosphate: a synthetic purine antimetabolite with significant activity against lymphoid malignancies.
Cheson, BD; Chun, HG; Leyland-Jones, B, 1991
)
2.45

Treatment

ExcerptReferenceRelevance
"(fludarabine phosphate) treatment in the common indolent B-cell neoplasms have led to their further evaluation in other unusual B-cell malignancies, in Hodgkin's disease, and in T-cell diseases."( Fludarabine phosphate therapy in other lymphoid malignancies.
Kantarjian, HM; Keating, MJ; Redman, JR, 1990
)
2.34

Toxicity

ExcerptReferenceRelevance
" To elucidate the mechanism of toxicity this work has examined the pharmacodynamics of F-araAMP anabolites, F-araATP and F-ATP, in P388 cells, BM and GI mucosa tissues after nontoxic (LD1) and toxic (LD50) doses of F-araAMP."( Pharmacodynamics and proposed mechanism of therapeutic action and host toxicity of 9-beta-D-arabinofuranosyl-2-fluoroadenine monophosphate (F-araAMP) in P388 murine leukemia-bearing mice.
Avramis, VI, 1989
)
0.28
" Transient neutropenia was the only side-effect seen in experimental animals."( Fludarabine phosphate: A DNA synthesis inhibitor with potent immunosuppressive activity and minimal clinical toxicity.
Athan, E; Fein, S; Fiedor, PS; Goodman, ER; Hardy, MA, 1996
)
1.74
" Safety monitoring included WHO toxicity grading for adverse events."( Efficacy and safety of oral fludarabine phosphate in previously untreated patients with chronic lymphocytic leukemia.
Berthou, C; Bron, D; de Boeck, K; Deconinck, E; Foussard, C; Guibon, O; Johnson, SA; Kramer, MH; Lister, TA; Littlewood, TJ; Marcus, RE; Montillo, M; Rossi, JF; Tollerfield, SM; van Hoof, A, 2004
)
0.62

Pharmacokinetics

ExcerptReferenceRelevance
" Concurrent with the phase I evaluation of 2-F-ara-AMP administered as a single intravenous (IV) bolus every 21 days to patients with advanced malignancy, plasma pharmacokinetic profiles of 2-F-ara-A were determined in 30 patients following the rapid infusion (2 to 5 minutes) of doses of 2-F-ara-AMP ranging from 80 to 260 mg/m2."( Pharmacokinetics of 2-F-ara-A (9-beta-D-arabinofuranosyl-2-fluoroadenine) in cancer patients during the phase I clinical investigation of fludarabine phosphate.
Grever, MR; Malspeis, L; Staubus, AE; Young, D, 1990
)
0.48
" A pharmacokinetic study of an oral formulation (10 mg immediate-release tablet) was undertaken in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia."( Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
Cullen, MH; de Takats, PG; Foran, JM; Johnson, SA; Klein, M; Kraus, C; Lister, TA; Orchard, J; Oscier, D; Tighe, M, 1999
)
0.56
" Pharmacokinetic samples taken after each trial dose were analyzed for plasma 2-fluoro-arabinofuranosyladenine (2F-ara-A) concentration (its main metabolite); area under the curve 0 to 24 hours (AUC(0-24h)) and maximum concentration (Cmax) were calculated."( Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
Cullen, MH; de Takats, PG; Foran, JM; Johnson, SA; Klein, M; Kraus, C; Lister, TA; Orchard, J; Oscier, D; Tighe, M, 1999
)
0.56
"Oral administration of F-AMP resulted in a dose-dependent increase in Cmax and AUC(0-24h) of 2F-ara-A and achieved an AUC(0-24h) similar to intravenous administration, although at a lower Cm."( Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
Cullen, MH; de Takats, PG; Foran, JM; Johnson, SA; Klein, M; Kraus, C; Lister, TA; Orchard, J; Oscier, D; Tighe, M, 1999
)
0.56
"The primary objective of this study was to investigate the tolerability, efficacy and pharmacokinetic profile of oral fludarabine phosphate in relapsed patients with indolent B-cell non-Hodgkin's lymphoma (B-NHL)."( Phase I and pharmacokinetic study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma.
Hotta, T; Minami, H; Morishima, Y; Ogawa, Y; Ogura, M; Sasaki, Y; Seriu, T; Tobinai, K; Watanabe, T, 2006
)
0.81
" Pharmacokinetic samples were taken on day 1 and day 5 of the first treatment cycle."( Phase I and pharmacokinetic study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma.
Hotta, T; Minami, H; Morishima, Y; Ogawa, Y; Ogura, M; Sasaki, Y; Seriu, T; Tobinai, K; Watanabe, T, 2006
)
0.6
" These patients experience significant interpatient variability in clinical outcomes, potentially due to pharmacokinetic variability in 2-fluoroadenine (F-ara-A) plasma concentrations."( A limited sampling schedule to estimate individual pharmacokinetic parameters of fludarabine in hematopoietic cell transplant patients.
Anasetti, C; Blough, DK; McCune, JS; O'Donnell, PV; Salinger, DH; Sandmaier, BM; Vicini, P, 2009
)
0.35
" NONMEM software was used to estimate the population pharmacokinetic parameters and compute the area under the concentration-time curve."( A limited sampling schedule to estimate individual pharmacokinetic parameters of fludarabine in hematopoietic cell transplant patients.
Anasetti, C; Blough, DK; McCune, JS; O'Donnell, PV; Salinger, DH; Sandmaier, BM; Vicini, P, 2009
)
0.35
" Mean (+/-SD) elimination half-life did not differ significantly between IV and oral dosage groups (11."( Pharmacokinetics, bioavailability and effects on electrocardiographic parameters of oral fludarabine phosphate.
Greenblatt, DJ; Karyagina, EV; Lister-James, J; Lundberg, AS; Yin, W, 2010
)
0.58
"Individual pharmacokinetic parameters were fixed to post hoc Bayesian estimates, and circulating absolute lymphocyte counts (ALC) were obtained during the 3 weeks prior to graft infusion."( Population pharmacokinetic/dynamic model of lymphosuppression after fludarabine administration.
Anasetti, C; Mager, DE; McCune, JS; O'Donnell, PV; Salinger, DH; Sandmaier, BM; Vicini, P, 2015
)
0.42
" Pharmacodynamic parameters exhibited considerable between subject variability (38."( Population pharmacokinetic/dynamic model of lymphosuppression after fludarabine administration.
Anasetti, C; Mager, DE; McCune, JS; O'Donnell, PV; Salinger, DH; Sandmaier, BM; Vicini, P, 2015
)
0.42

Compound-Compound Interactions

ExcerptReferenceRelevance
" Among these agents, cytarabine may be the best agent for the combination with fludarabine phosphate."( In vitro cytotoxic effects of fludarabine (2-F-ara-A) in combination with commonly used antileukemic agents by isobologram analysis.
Akutsu, M; Bai, L; Furukawa, Y; Ichikawa, A; Kano, Y; Kon, K; Suzuki, K; Tsunoda, S, 2000
)
0.53
"Randomized trials suggest improved disease-free survival in low-grade non-Hodgkin's lymphoma (LGNHL) when interferon is combined with multiagent chemotherapy."( Phase II study of fludarabine combined with interferon-alpha-2a followed by maintenance therapy with interferon-alpha-2a in patients with low-grade non-hodgkin's lymphoma.
Bewsher, CJ; Braylan, RC; Hei, DL; Hudson, JK; Lynch, JW; Mendenhall, NP; Rimzsa, LM; Staab, EV, 2002
)
0.31

Bioavailability

The pharmacokinetics, bioavailability and effects on electrocardiographic (ECG) parameters of fludarabine phosphate (2F-ara-AMP) were evaluated in adult patients with B-cell chronic lymphocytic leukemia.

ExcerptReferenceRelevance
" Eighteen patients received all three oral trial doses, and bioavailability was determined in 15 patients who completed four courses of therapy."( Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
Cullen, MH; de Takats, PG; Foran, JM; Johnson, SA; Klein, M; Kraus, C; Lister, TA; Orchard, J; Oscier, D; Tighe, M, 1999
)
0.56
" Bioavailability (approximately 55%, with low intraindividual variation) and time to Cmax were dose independent."( Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with "low-grade" non-Hodgkin's lymphoma and B-cell chronic lymphocytic leukemia.
Cullen, MH; de Takats, PG; Foran, JM; Johnson, SA; Klein, M; Kraus, C; Lister, TA; Orchard, J; Oscier, D; Tighe, M, 1999
)
0.56
"A prospective, open and randomized, two-way crossover study was conducted to evaluate the pharmacokinetics and bioavailability of oral fludarabine phosphate when taken on a full versus an empty stomach."( The bioavailability of oral fludarabine phosphate is unaffected by food.
Culligan, D; Cunningham, D; Gieschen, H; Johnson, S; Klein, M; Orchard, JA; Oscier, D; Parker, A, 2001
)
0.81
"Of 22 patients recruited, 18 (CLL n = 10; NHL n = 8) were eligible for efficacy and safety evaluation, and 16 for bioavailability and pharmacokinetic analyses."( The bioavailability of oral fludarabine phosphate is unaffected by food.
Culligan, D; Cunningham, D; Gieschen, H; Johnson, S; Klein, M; Orchard, JA; Oscier, D; Parker, A, 2001
)
0.6
"The pharmacokinetics, bioavailability and effects on electrocardiographic (ECG) parameters of fludarabine phosphate (2F-ara-AMP) were evaluated in adult patients with B-cell chronic lymphocytic leukemia."( Pharmacokinetics, bioavailability and effects on electrocardiographic parameters of oral fludarabine phosphate.
Greenblatt, DJ; Karyagina, EV; Lister-James, J; Lundberg, AS; Yin, W, 2010
)
0.8
" The oral bioavailability of F-ara-A from 1,2-dimyristoylglycerophosphate derivative 29 was similar to its oral bioavailability from fludarabine phosphate."( Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
Baranovsky, A; Bogushevich, S; Golubeva, M; Kalinichenko, E; Kulak, T; Kuzmitsky, B; Tsybulskaya, I, 2015
)
0.62

Dosage Studied

ExcerptRelevanceReference
" The parent drug was almost quantitatively converted to 2-F-ara-A by apparent first-pass metabolism, with maximum levels of 2-F-ara-A and very low levels (less than 1 fmol/L) of 2-F-ara-AMP observed only in the plasma samples obtained shortly after dosing (2 to 4 minutes)."( Pharmacokinetics of 2-F-ara-A (9-beta-D-arabinofuranosyl-2-fluoroadenine) in cancer patients during the phase I clinical investigation of fludarabine phosphate.
Grever, MR; Malspeis, L; Staubus, AE; Young, D, 1990
)
0.48
" No dosage or schedule could be recommended for patients with acute leukemia because of the severe neurotoxicity (progressive dementia with blindness leading to coma) noted with doses greater than or equal to 96 mg/m2/d for 5 to 7 days."( Phase I clinical trials with fludarabine phosphate.
Von Hoff, DD, 1990
)
0.57
" Initial dosing was based on the presence of previous radiation therapy."( Evaluation of fludarabine phosphate in malignant melanoma. A Southwest Oncology Group study.
Fletcher, WS; Kempf, RA; Kish, JA; Kopecky, K; Muggia, FM; Samson, MK; Von Hoff, DD, 1991
)
0.64
" Fludarabine phosphate by this alternative dosing schedule is effective in refractory advanced CLL and is well tolerated by the majority of patients."( A loading dose/continuous infusion schedule of fludarabine phosphate in chronic lymphocytic leukemia.
Ahmed, T; Arlin, ZA; Arnold, PM; Budman, DR; Coleman, M; Feldman, EJ; Lichtman, SM; Mittelman, A; Puccio, CA; Silver, RT, 1991
)
1.45
" Mean (+/-SD) elimination half-life did not differ significantly between IV and oral dosage groups (11."( Pharmacokinetics, bioavailability and effects on electrocardiographic parameters of oral fludarabine phosphate.
Greenblatt, DJ; Karyagina, EV; Lister-James, J; Lundberg, AS; Yin, W, 2010
)
0.58
" These data suggest that clinical strategies are needed to optimize dosing of fludarabine to prevent overexposure and toxicity in HCT."( High fludarabine exposure and relationship with treatment-related mortality after nonmyeloablative hematopoietic cell transplantation.
Brunstein, CG; Cao, Q; Green, KG; Jacobson, PA; Long-Boyle, JR; McGlave, PB; Miller, JS; Rogosheske, J; Wagner, JE; Weisdorf, DJ, 2011
)
0.37
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (6)

RoleDescription
antimetaboliteA substance which is structurally similar to a metabolite but which competes with it or replaces it, and so prevents or reduces its normal utilization.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
immunosuppressive agentAn agent that suppresses immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-cells or by inhibiting the activation of helper cells. In addition, an immunosuppressive agent is a role played by a compound which is exhibited by a capability to diminish the extent and/or voracity of an immune response.
antiviral agentA substance that destroys or inhibits replication of viruses.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
DNA synthesis inhibitorAny substance that inhibits the synthesis of DNA.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
purine arabinonucleoside monophosphateA purine nucleoside monophosphate in which the sugar component is specified as arabinosyl.
organofluorine compoundAn organofluorine compound is a compound containing at least one carbon-fluorine bond.
nucleoside analogueAn analogue of a nucleoside, being an N-glycosyl compound in which the nitrogen-containing moiety is a modified nucleotide base. They are commonly used as antiviral products to prevent viral replication in infected cells.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (7)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
Carbonic anhydrase 1Homo sapiens (human)Ki10.00000.00001.372610.0000AID1564385
Carbonic anhydrase 2Homo sapiens (human)Ki10.00000.00000.72369.9200AID1564386
Carbonic anhydrase 5A, mitochondrialHomo sapiens (human)Ki0.13090.00001.27259.9000AID1564387
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (53)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 1Homo sapiens (human)
morphogenesis of an epitheliumCarbonic anhydrase 2Homo sapiens (human)
positive regulation of synaptic transmission, GABAergicCarbonic anhydrase 2Homo sapiens (human)
positive regulation of cellular pH reductionCarbonic anhydrase 2Homo sapiens (human)
angiotensin-activated signaling pathwayCarbonic anhydrase 2Homo sapiens (human)
regulation of monoatomic anion transportCarbonic anhydrase 2Homo sapiens (human)
secretionCarbonic anhydrase 2Homo sapiens (human)
regulation of intracellular pHCarbonic anhydrase 2Homo sapiens (human)
neuron cellular homeostasisCarbonic anhydrase 2Homo sapiens (human)
positive regulation of dipeptide transmembrane transportCarbonic anhydrase 2Homo sapiens (human)
regulation of chloride transportCarbonic anhydrase 2Homo sapiens (human)
carbon dioxide transportCarbonic anhydrase 2Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 2Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (29)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
arylesterase activityCarbonic anhydrase 1Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 1Homo sapiens (human)
protein bindingCarbonic anhydrase 1Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 1Homo sapiens (human)
hydro-lyase activityCarbonic anhydrase 1Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 1Homo sapiens (human)
arylesterase activityCarbonic anhydrase 2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 2Homo sapiens (human)
protein bindingCarbonic anhydrase 2Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 2Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
zinc ion bindingCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (23)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
cytosolCarbonic anhydrase 1Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 1Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
cytosolCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
myelin sheathCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 2Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
mitochondrial matrixCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
mitochondrionCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
cytoplasmCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
mitochondrionCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (28)

Assay IDTitleYearJournalArticle
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1564386Inhibition of recombinant human carbonic anhydrase 2 preincubated with enzyme for 15 mins by phenol red dye based stopped flow CO2 hydration assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A computer-assisted discovery of novel potential anti-obesity compounds as selective carbonic anhydrase VA inhibitors.
AID1236727Apparent half-life in ICR mouse assessed as F-ara-A content at 50 mg/kg, ig administered as single dose by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236703Antiproliferative activity against human ZR-75-1 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1236731AUC(0 to 24 hrs) in ICR mouse at 50 mg/kg, ig administered as single dose by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236698Antiproliferative activity against human KG1 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236725Tmax in ICR mouse assessed as F-ara-A concentration at 50 mg/kg, ig administered as single dose by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1564385Inhibition of recombinant human carbonic anhydrase 1 preincubated with enzyme for 15 mins by phenol red dye based stopped flow CO2 hydration assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A computer-assisted discovery of novel potential anti-obesity compounds as selective carbonic anhydrase VA inhibitors.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID1236723Cmax in ICR mouse assessed as F-ara-A concentration at 50 mg/kg, ig administered as single dose by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236697Antiproliferative activity against human MOLT3 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1236699Antiproliferative activity against human K562 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236705Antiproliferative activity against human HL60 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID409958Inhibition of bovine brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1236704Antiproliferative activity against human SK-UT-1B cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1236707Antiproliferative activity against human M-HeLa cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236702Antiproliferative activity against human MCF7 cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1564387Inhibition of recombinant human carbonic anhydrase VA preincubated with enzyme for 15 mins by phenol red dye based stopped flow CO2 hydration assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A computer-assisted discovery of novel potential anti-obesity compounds as selective carbonic anhydrase VA inhibitors.
AID1236729Cmin in ICR mouse assessed as F-ara-A concentration at 50 mg/kg, ig administered as single dose after 24 hrs by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236706Antiproliferative activity against human Raji cells assessed as cell growth inhibition after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID1236721AUC(0 to 24 hrs) in Wistar rat at 72 mg/kg, ig administered as single dose by HPLC analysis2015Bioorganic & medicinal chemistry, Jul-01, Volume: 23, Issue:13
Phospholipid derivatives of cladribine and fludarabine: synthesis and biological properties.
AID409960Inhibition of bovine brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (215)

TimeframeStudies, This Drug (%)All Drugs %
pre-199041 (19.07)18.7374
1990's89 (41.40)18.2507
2000's59 (27.44)29.6817
2010's21 (9.77)24.3611
2020's5 (2.33)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 32.77

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index32.77 (24.57)
Research Supply Index5.58 (2.92)
Research Growth Index4.57 (4.65)
Search Engine Demand Index47.56 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (32.77)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials46 (21.10%)5.53%
Reviews25 (11.47%)6.00%
Case Studies24 (11.01%)4.05%
Observational0 (0.00%)0.25%
Other123 (56.42%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (544)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Pilot Study of Intensified Lymphodepletion Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Systemic Lupus Erythematosus [NCT00076752]Phase 29 participants (Actual)Interventional2004-01-30Completed
A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00086580]Phase 3335 participants (Actual)Interventional2004-07-31Completed
A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL) [NCT02048813]Phase 3529 participants (Actual)Interventional2014-02-20Active, not recruiting
Allogeneic Hematopoietic Cell Transplantation for Patients With Non-Malignant Disorders Using Treosulfan, Fludarabine, and Thiotepa [NCT03980769]Phase 240 participants (Anticipated)Interventional2021-05-05Recruiting
Phase II Study of Reduced-Intensity Allogeneic Stem Cell Transplant for High-Risk Chronic Lymphocytic Leukemia (CLL) [NCT01027000]Phase 268 participants (Actual)Interventional2010-02-28Completed
CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related/Unrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study [NCT04375631]Phase 1120 participants (Anticipated)Interventional2020-12-03Recruiting
A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies [NCT02333162]Phase 130 participants (Anticipated)Interventional2014-12-05Recruiting
Dose-reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study (RICMAC) [NCT01203228]Phase 3129 participants (Actual)Interventional2004-05-31Terminated
Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances [NCT05110742]Phase 1/Phase 248 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML) [NCT02642965]Phase 1/Phase 238 participants (Actual)Interventional2016-05-02Completed
A Phase I Trial of Ruxolitinib Combined With Tacrolimus and Sirolimus as Acute Graft-versus-Host Disease (aGVHD) Prophylaxis During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis [NCT02528877]Phase 10 participants (Actual)Interventional2015-11-30Withdrawn(stopped due to The study design was revised so a new protocol will be opened.)
Related and Unrelated Donor Hematopoietic Stem Cell Transplant for DOCK8 Deficiency [NCT01176006]Phase 290 participants (Anticipated)Interventional2010-10-05Recruiting
A Phase Ib Study to Evaluate Safety and Persistence of ex Vivo Expanded Universal Donor NK Cells in Combination With IL-2 and TGFbeta Receptor I Inhibitor Vactosertib in Patients With Locally Advanced/Metastatic Colorectal Cancer and Relapsed/Refractory H [NCT05400122]Phase 112 participants (Anticipated)Interventional2022-09-09Suspended(stopped due to Insufficient staff)
A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma [NCT04545762]Phase 136 participants (Anticipated)Interventional2020-09-11Recruiting
Allogeneic Hematopoietic Cell Transplantation With HLA-matched Donors : a Phase II Randomized Study Comparing 2 Nonmyeloablative Conditionings [NCT00603954]Phase 2107 participants (Actual)Interventional2008-01-31Completed
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia (BMT CTN #0901) [NCT01339910]Phase 3272 participants (Actual)Interventional2011-06-30Terminated(stopped due to Accrual terminated as recommended by the data and safety monitoring board.)
A Pilot Study of Myeloablative Allogeneic or Haploidentical Stem Cell Transplantation With High Dose PT-Cy in Relapsed/Refractory AML [NCT02057770]Phase 125 participants (Actual)Interventional2014-02-28Terminated(stopped due to Low accrual rate)
NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With CTLA4 Blockade [NCT02070406]Phase 14 participants (Actual)Interventional2014-07-17Terminated(stopped due to low accrual)
A Feasibility Trial of MLN4924 (Pevonedistat, TAK 924) Given in Combination With Azacitidine, Fludarabine, and Cytarabine, in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome [NCT03813147]Phase 112 participants (Actual)Interventional2019-05-17Active, not recruiting
A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma [NCT01145209]Phase 232 participants (Actual)Interventional2010-07-01Completed
Allogeneic Stem Cell Transplantation for Patients With Hematological Malignancies Using Multiple Unrelated Cord Blood Units [NCT00547196]10 participants (Actual)Interventional2005-08-16Active, not recruiting
A Randomized Phase II Study to Compare ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation [NCT03602898]Phase 20 participants (Actual)Interventional2021-06-01Withdrawn(stopped due to Insufficient funding)
Phase I Trial of Escalated Doses of Targeted Marrow Irradiation (TMI) Combined With Fludarabine and Busulfan as Conditioning Regimen for Allogeneic Hematopoietic Progenitor Cell Transplantation [NCT02129582]Phase 114 participants (Actual)Interventional2014-11-05Completed
Efficacy and Safety of Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma:a Single-center, Open-label, Pragmatic Clinical Trial [NCT05020392]Phase 324 participants (Anticipated)Interventional2021-09-14Recruiting
Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source [NCT01028716]Phase 246 participants (Actual)Interventional2010-05-19Terminated(stopped due to The study experienced lower accrual rates after the onset of COVID. Upon review of the collected data it was deemed that an adequate amount of subjects has been enrolled to date to assess study aims.)
A Phase I/II Study of Fludarabine Plus Thalidomide as Frontline Therapy for Newly Diagnosed Patients With Chronic Lymphocytic Leukemia [NCT00096018]Phase 1/Phase 243 participants (Actual)Interventional2002-05-31Completed
Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-p53 T Cell Receptor (TCR)-Gene Engineered Lymphocytes [NCT00393029]Phase 212 participants (Actual)Interventional2006-10-31Completed
Randomized Trial of Unmanipulated Versus Expanded Cord Blood [NCT00067002]Phase 2110 participants (Actual)Interventional2003-04-30Completed
Autologous TRAC Locus-inserted CD19-targeting Synthetic T-cell Receptor Antigen Receptor T (STAR-T) Cells for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma [NCT05631912]Phase 1/Phase 238 participants (Anticipated)Interventional2023-06-30Recruiting
Phase II Trial Of Non-Myeloablative Regimen Combining Melphalan, Fludarabine, And Anti-CD52 Monoclonal Antibody (CAMPATH-1H) Followed By An Unmodified Hematopoietic Cell Transplant From An HLA Compatible Related Or Unrelated Donor For Treatment Of Lymphoh [NCT00027560]Phase 251 participants (Actual)Interventional2001-07-31Completed
Allogeneic Transplantation Using Venetoclax, Timed Sequential Busulfan,Cladribine, and Fludarabine Conditioning in Patients With AML and MDS [NCT02250937]Phase 2116 participants (Anticipated)Interventional2014-10-27Active, not recruiting
Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells [NCT05088356]Phase 140 participants (Anticipated)Interventional2021-09-07Recruiting
Hematopoietic Cell Transplantation Using Treosulfan-Based Conditioning for the Treatment of Bone Marrow Failure Diseases [NCT04965597]Phase 240 participants (Anticipated)Interventional2022-04-19Recruiting
Phase II Study of MK-3475 in Conjunction With Lymphodepletion, TIL, and High or Low Dose IL-2 in Patients With Metastatic Melanoma [NCT02500576]Phase 218 participants (Actual)Interventional2015-08-07Completed
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies [NCT01652092]30 participants (Anticipated)Interventional2012-09-04Recruiting
A Phase 1/2 Study of Cytokine-Induced Memory-Like NK Cells in Patients With AML or MDS [NCT01898793]Phase 1/Phase 289 participants (Actual)Interventional2014-08-11Terminated(stopped due to Insufficient funding/staff)
Phase I/II Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma [NCT05703854]Phase 1/Phase 250 participants (Anticipated)Interventional2023-03-29Recruiting
A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG [NCT01256398]Phase 266 participants (Actual)Interventional2010-12-14Completed
CD19+ Chimeric Antigen Receptor T Cells for Patients With Advanced Lymphoid Malignancies [NCT02529813]Phase 126 participants (Actual)Interventional2015-12-16Completed
A Pilot Study of Reduced Intensity HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Advanced Myelofibrosis [NCT03426969]Early Phase 13 participants (Actual)Interventional2018-01-31Completed
Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances [NCT05092451]Phase 1/Phase 294 participants (Anticipated)Interventional2022-11-01Recruiting
Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia and Myelodysplastic Syndrome [NCT00357565]Phase 220 participants (Anticipated)Interventional2005-11-30Recruiting
High-dose Post-transplantation Cyclophosphamide as Graft Versus-host Disease Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation [NCT02294552]Phase 2200 participants (Actual)Interventional2014-10-31Completed
Glypican 3-specific Chimeric Antigen Receptor Expressed in Autologous T Cells as Immunotherapy for Patients With Pediatric Solid Tumors [NCT02932956]Phase 110 participants (Actual)Interventional2018-12-17Active, not recruiting
A Study to Infuse ROR1-Specific Autologous T Cells for Patients With Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) [NCT02194374]Phase 10 participants (Actual)Interventional2015-01-31Withdrawn(stopped due to Study closed with no enrollment due to unavailability of reagent.)
Fludarabine-Based Conditioning for Matched Related Donor Bone Marrow Transplantation in Patients With Bone Marrow Failure Syndromes [NCT02928991]Early Phase 175 participants (Anticipated)Interventional2015-04-30Recruiting
Anti-CD22 Immunoconjugate Inotuzumab Ozogamicin (CMC-544) Added to Fludarabine, Bendamustine and Rituximab and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies [NCT01664910]Phase 1/Phase 227 participants (Actual)Interventional2012-10-29Completed
Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT) [NCT03326921]Phase 124 participants (Anticipated)Interventional2018-02-23Suspended(stopped due to Pause in funding)
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA) [NCT06066424]Phase 154 participants (Anticipated)Interventional2023-10-24Recruiting
International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017 [NCT03643276]Phase 35,000 participants (Anticipated)Interventional2018-07-15Recruiting
A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia [NCT01085617]Phase 31,033 participants (Actual)Interventional2010-12-31Active, not recruiting
Decitabine-primed Tandem Targeting CD19 and CD20 Chimeric Antigen Receptor T Cells Treatment in Relapsed and/or Refractory Non-Hodgkin's Lymphoma Patients [NCT04697940]Phase 1/Phase 233 participants (Anticipated)Interventional2020-12-15Recruiting
Intra-osseous Co-transplant of Cord Blood and Mesenchymal Stromal Cells: A Feasibility Study [NCT02181478]Early Phase 16 participants (Actual)Interventional2015-07-22Completed
Pilot Study of Allogeneic/Syngeneic Blood Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas [NCT00043979]Phase 260 participants (Actual)Interventional2002-09-19Completed
Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer [NCT00074269]Phase 25 participants (Actual)Interventional2003-07-31Terminated(stopped due to Terminated early due to poor enrollment)
A Dose-escalation Clinical Study of QH103 Cell Injection (CD19 CAR-γδT Cell Injection) in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). [NCT06056752]Phase 110 participants (Anticipated)Interventional2023-09-27Recruiting
Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS) [NCT05991908]Phase 3222 participants (Anticipated)Interventional2023-10-19Recruiting
Fludarabine/Clofarabine/Busulfan Combined With SAHA in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia [NCT02083250]Phase 170 participants (Actual)Interventional2014-03-06Completed
Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) With Pembrolizumab, in Subjects Who Have Failed Cisplatin-Based Chemotherapy With Locally Advanced (Unresectable) or Metastatic Transitional Cell Cancer (TCC) of the Urothelium [NCT03935347]Phase 20 participants (Actual)Interventional2019-06-20Withdrawn(stopped due to no accrual)
An Assessment of the Safety and Feasibility of Administering T-Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With B-Cell Lymphoma [NCT00924326]Phase 1/Phase 243 participants (Actual)Interventional2009-02-17Completed
Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers [NCT02876510]Phase 138 participants (Actual)Interventional2017-06-30Completed
A Phase II Study of Fludarabine Induction With Sequential High Dose Cyclophosphamide and Rituximab as Consolidation Therapy for Previously Untreated Patients With Intermediate and High-Risk Chronic Lymphocytic Leukemia [NCT00003659]Phase 239 participants (Actual)Interventional1998-09-30Completed
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for B-Cell Non-Hodgkin Lymphoma Using Zevalin, Fludarabine and Melphalan [NCT00577278]Phase 241 participants (Actual)Interventional2007-10-03Active, not recruiting
A Cancer Research UK Phase I Trial of Adoptive Transfer of Autologous Tumor Antigen-Specific T Cells With Preconditioning Chemotherapy and Intravenous IL2 in Patients With Advanced CEA Positive Tumors [NCT01212887]Phase 114 participants (Actual)Interventional2007-08-31Terminated(stopped due to due to safety concerns and lack of efficacy)
A Randomized Study of Once Daily Fludarabine-Clofarabine Versus Fludarabine Alone Combined With Intervenous Busulfan Followed by Allogeneic Hemopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) [NCT01471444]Phase 3256 participants (Actual)Interventional2011-11-02Completed
JAK Inhibitor Prior to Allogeneic Stem Cell Transplant for Patients With Primary and Secondary Myelofibrosis: A Prospective Study [NCT02251821]Phase 299 participants (Actual)Interventional2014-10-20Active, not recruiting
A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome [NCT03071276]Phase 237 participants (Actual)Interventional2016-01-14Terminated(stopped due to Due to slow enrollment)
A Pilot Study to Assess Engraftment Using CliniMACS TCR-α/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Progenitor Cell Transplantation (HSCT) in Patients With Relapsed Lymphoma [NCT02652468]11 participants (Actual)Interventional2016-03-10Completed
GD2-CAR PERSIST: Production and Engineering of GD2-Targeted, Receptor Modified T Cells (GD2CART) for Osteosarcoma or Neuroblastoma to Increase Systemic Tumor Exposure [NCT04539366]Phase 167 participants (Anticipated)Interventional2022-01-25Suspended(stopped due to Interim Monitoring)
A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome [NCT01019317]Phase 2151 participants (Actual)Interventional2009-11-30Completed
A Study Evaluating Escalating Doses of 90Y-DOTA-BC8 (Anti-CD45) Antibody Followed by Allogeneic Stem Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) [NCT01300572]Phase 116 participants (Actual)Interventional2012-01-31Completed
Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide Followed by Rituximab/Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Concomitant Evaluation of Safety and Efficacy. [NCT00738829]Phase 1/Phase 245 participants (Actual)Interventional2008-10-31Completed
Allograft of Hematopoietic Stem Cells With Reduced-intensity Conditioning From a HLA-haploidentical Family Donor: Phase II Study of Combined Immunosuppression Before and After Transplantation [NCT00740467]Phase 250 participants (Anticipated)Interventional2008-01-31Recruiting
A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies [NCT02566304]Phase 235 participants (Anticipated)Interventional2015-11-13Active, not recruiting
A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation [NCT00691015]Phase 248 participants (Actual)Interventional2008-05-31Completed
Allogeneic Hematopoietic Cell Transplant for Hematological Cancers and Myelodysplastic Syndromes in HIV-Infected Individuals (BMT CTN #0903) [NCT01410344]Phase 220 participants (Actual)Interventional2011-09-30Completed
Trial of the Efficacy and Safety of High-dose Immunosuppressive Therapy Based on Fludarabine and Cyclophosphamide-containing Conditioning Regimen Followed by Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis. [NCT05832515]Phase 1200 participants (Anticipated)Interventional2020-10-01Recruiting
Phase II Study of Allogeneic Transplant of Hematopoietic Stem Cells From a Compatible Family Donor in the Treatment of Patients Over 55 Years With Hematological Malignancies [NCT00806767]Phase 282 participants (Anticipated)Interventional2007-03-31Completed
Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL [NCT00840385]Phase 230 participants (Anticipated)Interventional2007-11-30Recruiting
Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan [NCT00619645]Phase 28 participants (Actual)Interventional2007-06-30Completed
A Multicenter Pilot Study of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation With In-vivo T-cell Depletion to Evaluate the Role of NK Cells and KIR Mis-matches in Relapsed or Refractory High-risk Neuroblastoma. [NCT00874315]Phase 20 participants (Actual)Interventional2008-09-30Withdrawn(stopped due to lack of accrual)
A Phase 1/2a, Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors [NCT05672459]Phase 1/Phase 2117 participants (Anticipated)Interventional2023-06-21Recruiting
Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis [NCT02917096]Phase 118 participants (Actual)Interventional2016-11-13Completed
Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult P [NCT02153580]Phase 137 participants (Actual)Interventional2014-09-24Active, not recruiting
A Trial of Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions for Patients With Relapsed or High-Risk Multiple Myeloma [NCT01131169]Phase 266 participants (Actual)Interventional2010-05-31Completed
Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02 [NCT00258427]Phase 214 participants (Actual)Interventional2002-03-26Completed
Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells to Augment Single or Double Myeloablative Cord Blood Transplantation in Patients With Hematologic Malignancies [NCT01175785]Phase 215 participants (Actual)Interventional2010-08-31Completed
Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes [NCT02774291]Early Phase 13 participants (Actual)Interventional2017-04-20Terminated(stopped due to Due to lack of accrual the study was formally terminated on 01-JUL-2020. Primary Completion and Study Completion Dates have been revised based accordingly based on respective definitions)
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol [NCT02447055]Early Phase 10 participants (Actual)Interventional2015-12-31Withdrawn
Combined Transplantation of Unmanipulated Haploidentical and a SingleCord Blood Unit for Patients With Hematologic Malignancies [NCT01359254]Phase 21 participants (Actual)Interventional2010-04-30Terminated(stopped due to did not accrue enough patients.)
A Phase 1 Single Arm, Open Label Study to Evaluate the Safety of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas [NCT05400109]Phase 110 participants (Anticipated)Interventional2023-04-26Recruiting
A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia [NCT05955261]Phase 270 participants (Anticipated)Interventional2023-07-25Recruiting
A Phase I Study to Evaluate PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer [NCT03873805]Phase 114 participants (Actual)Interventional2019-08-20Active, not recruiting
A Phase I/II Open-Label Study of ECT-001-Expanded Cord Blood Transplantation in Pediatric and Young Adult (<21year) Patients With High-Risk and Very High-Risk Myeloid Malignancies [NCT04990323]Phase 1/Phase 212 participants (Anticipated)Interventional2021-12-01Recruiting
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma [NCT06043323]Phase 220 participants (Anticipated)Interventional2024-03-31Not yet recruiting
"A Pilot Window-3 Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma" [NCT05495464]Early Phase 120 participants (Anticipated)Interventional2022-11-18Recruiting
Study to Infuse Haploidentical Natural Killer Cells in Patients With Relapsed or Refractory Neuroblastoma [NCT00698009]Phase 21 participants (Actual)Interventional2008-06-30Terminated(stopped due to Slow accrual.)
Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma [NCT00958854]Phase 237 participants (Anticipated)Interventional2006-01-31Recruiting
T-Cell or Natural Killer (NK) Cell Adback in Patients With Lymphoid Malignancies Receiving Allogeneic Stem Cell Transplantation With Campath-IH Containing Conditioning Regimens [NCT00536978]Phase 222 participants (Actual)Interventional2007-09-30Completed
CD34+Stem Cell Selection for Patients Receiving Partially Matched Family or Matched Unrelated Adult Donor Allogeneic Stem Cell Transplantations for Malignant and Non-Malignant Disease [NCT01049854]Phase 220 participants (Actual)Interventional2011-09-30Completed
Active Immunization of Sibling Stem Cell Transplant Donors Against Purified Myeloma Protein of the Stem Cell Recipient With Multiple Myeloma in the Setting of Non-Myeloablative, HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation [NCT00006184]Phase 220 participants (Actual)Interventional2001-02-08Completed
A Multi-center Phase III Study Comparing Nonmyeloablative Conditioning With TBI Versus Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies [NCT00075478]Phase 387 participants (Actual)Interventional2003-10-31Completed
Phase I Study of Infusion of Umbilical Cord Blood (UCB) Derived CD25+CD4+ T-Regulatory (Treg) Cells After Nonmyeloablative Cord Blood Transplantation [NCT00602693]Phase 141 participants (Actual)Interventional2007-07-23Completed
A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients [NCT00925873]Phase 3303 participants (Actual)Interventional1996-06-30Completed
A Phase 1 Study of Obatoclax Mesylate (GX15-070MS) in Combination With Fludarabine-Based Chemoimmunotherapy in Previously Treated Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL) [NCT00612612]Phase 128 participants (Actual)Interventional2008-01-31Terminated
HLA-Identical Sibling Donor Bone Marrow Transplantation for Individuals With Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen [NCT02776202]Phase 215 participants (Anticipated)Interventional2016-05-31Recruiting
Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC) [NCT06096038]Phase 1/Phase 233 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Open-label, Phase I, Multi-center Study to Determine in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolid [NCT04167696]Phase 127 participants (Anticipated)Interventional2019-11-25Recruiting
A Phase 2, Multicenter, Randomized Open-Label Study To Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT00875667]Phase 2254 participants (Actual)Interventional2009-04-30Completed
A Phase 1 Trial of the Wee1 Kinase Inhibitor AZD1775 in Combination With Flag Chemotherapy in Children, Adolescents, and Young Adults With Relapsed or Refractory Acute Myeloid Leukemia [NCT02791919]Phase 10 participants (Actual)Interventional2017-05-25Withdrawn(stopped due to Other - Protocol moved to Disapproved)
Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Treosulfan Based Preparative Regimen [NCT00796068]Phase 2130 participants (Actual)Interventional2009-02-24Completed
Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics [NCT06013423]Phase 254 participants (Anticipated)Interventional2024-02-06Not yet recruiting
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells [NCT00354172]Phase 216 participants (Actual)Interventional2006-02-28Terminated(stopped due to Competing study was started.)
T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. [NCT00937625]Phase 1/Phase 231 participants (Actual)Interventional2009-06-30Completed
Busulfan-Fludarabine-Clofarabine With Allogeneic Stem Cell Transplantation for Advanced Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Advanced, Gleevec Refractory Chronic Myeloid Leukemia. A Randomized Phase II Study. [NCT00469014]Phase 272 participants (Actual)Interventional2006-09-30Completed
Evaluation of Fludarabine, Busulfan and Alemtuzumab as a Reduced Toxicity Ablative Bone Marrow Stem Cell Transplant Regimen for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myelodysplastic Syndrome (MDS)/Leukemia [NCT00301834]Phase 235 participants (Actual)Interventional2005-01-31Completed
Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Haematological Diseases Using a Reduced Intensity Conditioning Regimen [NCT00959231]Phase 260 participants (Anticipated)Interventional2009-01-31Recruiting
Infusion of Expanded Cord Blood T Cells Following Cord Blood Transplantation [NCT00972101]Phase 10 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to Development of other studies led to termination without recruitment.)
Hematopoietic Cell Transplantation for Patients With High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) Using Radiolabeled DOTA-Biotin Pretargeted by BC8 Antibody-Streptavidin Conjugate [NCT00988715]Phase 117 participants (Actual)Interventional2010-04-21Completed
Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Myelogenous Leukemia in Remission Using HLA-Matched Sibling Donors, HLA-Matched Unrelated Donors, or HLA-Mismatched Familial Donors - A Phase 2 Study [NCT01020734]Phase 2263 participants (Actual)Interventional2011-05-31Completed
Phase II Trial of Combined Immunochemotherapy With Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients With Previously Treated or Untreated T-Prolymphocytic Leukemia [NCT01186640]Phase 216 participants (Actual)Interventional2010-06-30Completed
A Two-Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Advanced Cutaneous T Cell Lymphoma [NCT02548468]Phase 10 participants (Actual)Interventional2015-11-20Withdrawn(stopped due to Slow accrual)
A Multi-Center Study of Conditioning With Treosulfan, Fludarabine and Escalating Doses of TBI for Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS), and Acute Lymphoblastic Leukemia [NCT00860574]Phase 296 participants (Actual)Interventional2009-02-28Completed
A Phase I and Dose Expansion Cohort Study of Panobinostat in Combination With Fludarabine and Cytarabine in Pediatric Patients With Refractory or Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndrome [NCT02676323]Phase 119 participants (Actual)Interventional2016-05-03Terminated(stopped due to Slow accrual)
A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation [NCT00856388]62 participants (Actual)Interventional2009-01-14Completed
Randomized Trial of GVHD Prophylasxis With Post-transplantation Cyclophocphomide (PTCy) or Thymoglobulin in Unrelated SCT Recepients With Chronic Myeloproliferative Neoplasms and Myelodisplatic Syndrome [NCT02627573]Phase 232 participants (Actual)Interventional2015-07-31Terminated(stopped due to Poor recruitment)
A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 2 [NCT00688883]Phase 252 participants (Actual)Interventional2003-02-28Completed
Allogeneic γ9δ2 T Cells for the Treatment of Recurrent Hematologic Tumors After Allogeneic Hematopoietic Stem Cell Transplantation [NCT05755854]Phase 110 participants (Anticipated)Interventional2023-05-03Recruiting
Phase II Trial of a Chemotherapy Alone Regimen of IV Busulfan (Busulfex), Melphalan and Fludarabine as Myeloablative Regimen Followed by an Allogeneic T-Cell Depleted Hematopoietic Stem Cell Transplant From an HLA-Identical, or HLA-Non Identical Related o [NCT00582933]Phase 296 participants (Actual)Interventional2001-05-31Completed
A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic Malignancies [NCT01760655]Phase 262 participants (Actual)Interventional2012-12-24Completed
G-CSF and Plerixafor With Busulfan and Fludarabine for Allogeneic Stem Cell Transplantation for Myeloid Leukemias [NCT00822770]Phase 1/Phase 247 participants (Actual)Interventional2009-01-31Completed
Fludarabine, Cyclophosphamide, and Multiple Dose Rituximab as Frontline Therapy in Chronic Lymphocytic Leukemia (CLL) [NCT00794820]Phase 266 participants (Actual)Interventional2003-12-31Completed
Three-arm Clinical Trial for Patients With Hematologic Malignancies and Mismatched Donors - Haploidentical, 1 Antigen Mismatch Related or Unrelated, and Matched Unrelated Donor (MUD)- Using a T-cell Replete Allograft and High-dose Post-transplant Cyclopho [NCT01010217]Phase 2176 participants (Actual)Interventional2009-11-05Completed
Post Transplant Cyclophosphamide for Unrelated and Related Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies [NCT01349101]Phase 280 participants (Actual)Interventional2011-02-10Completed
A Randomised Trial of Chlorambucil Versus Fludarabine as Initial Therapy of Waldenström's Macroglobulinaemia and Splenic Lymphoma With Villous Lymphocytes [NCT00608374]Phase 3400 participants (Anticipated)Interventional2006-06-30Completed
Phase III Randomized Trial of Fludarabine and Cyclophosphamide Versus Fludarabine for Previously Untreated Chronic Lymphocytic Leukemia [NCT00003764]Phase 3280 participants (Anticipated)Interventional2000-03-09Completed
A Phase II Study of Fludarabine (F), Rituxan (R) and Avastin (A) Followed by RA Maintenance in Patients With Relapsed/Refractory B-cell Chronic Lymphocytic Leukemia (CLL) [NCT00845104]Phase 20 participants (Actual)Interventional2009-01-31Withdrawn(stopped due to No patients enrolled.)
A Phase II Study of Reduced Intensity Sibling Allogeneic Transplantation for Relapsed, Chemosensitive, PET-positive Hodgkin Lymphoma [NCT00907036]Phase 249 participants (Anticipated)Interventional2009-07-31Not yet recruiting
A Phase I/II Study of Azacitidine in Haploidentical Donor Hematopoietic Cell Transplantation [NCT02750254]Phase 15 participants (Actual)Interventional2016-06-27Terminated(stopped due to Toxicity. Only enrolled patients in phase I portion of trial.)
T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study. [NCT00937300]Phase 10 participants (Actual)Interventional2009-06-30Withdrawn(stopped due to The patients eligible for this trial do not exist anymore due to change in procedures.)
T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer [NCT04611126]Phase 1/Phase 218 participants (Anticipated)Interventional2021-04-22Recruiting
A Phase I Study to Evaluate the Safety of Escalating Doses of Lymphodepleting Conditioning Chemotherapy Prior to CD19 Chimeric Antigen Receptor T Cells in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma [NCT05052528]Phase 136 participants (Anticipated)Interventional2021-09-17Recruiting
The Treatment of Hematologic Malignancies With Single or Double Umbilical Cord Blood Unit Transplantation Followed by Graft-versus-Host Prophylaxis With Tacrolimus and Mycophenolate Mofetil [NCT00608517]6 participants (Actual)Interventional2005-09-30Terminated(stopped due to slow accrual)
A Phase II Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma [NCT00513604]Phase 2158 participants (Actual)Interventional2007-06-30Completed
Adoptive Transfer of Haploidentical NK Cells in Combination With Epratuzumab for the Treatment of Relapsed Acute Lymphoblastic Leukemia [NCT00941928]Phase 22 participants (Actual)Interventional2009-07-31Terminated(stopped due to Slow accrual)
Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for Patients With GATA2 Mutations [NCT00923364]Phase 219 participants (Actual)Interventional2009-05-07Completed
A Multi-center Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD [NCT00914940]Phase 241 participants (Actual)Interventional2009-12-17Terminated(stopped due to Did not reach one of the primary endpoints of decreased total acute GVHD)
Pilot Study of Unrelated Cord Blood Transplantation in Patients With Poor Risk Haematological Malignancies [NCT00916045]Phase 240 participants (Anticipated)Interventional2009-09-30Terminated(stopped due to Recruitment issues)
Romidepsin Therapy in Conditioning and Maintenance in Patients With T-Cell Malignancies Receiving Allogeneic Stem Cell Transplant [NCT02512497]Phase 110 participants (Anticipated)Interventional2017-12-08Recruiting
Safety and Efficacy Study of Busulfan/FLAG Conditioning Regimen in Patients With Relapsed/Refractory Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation [NCT02784561]Phase 480 participants (Anticipated)Interventional2016-07-31Not yet recruiting
A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD) [NCT05040568]Phase 115 participants (Anticipated)Interventional2022-02-28Recruiting
Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies [NCT00815568]Phase 2114 participants (Anticipated)Interventional2008-08-31Recruiting
Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) [NCT00813124]Phase 224 participants (Actual)Interventional2008-12-31Completed
Reduced Intensity Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) Supplemented With Donor Natural Killer (NK) Cell Infusions in Patients With High Risk Myeloid Malignancies Who Are Unsuitable for Fully Myeloablative Transplantation [NCT00303667]Phase 1/Phase 250 participants (Actual)Interventional2005-01-31Completed
A Genetic Risk-Stratified, Randomized Phase II Study of Four Fludarabine/Antibody Combinations for Patients With Symptomatic, Previously Untreated Chronic Lymphocytic Leukemia [NCT00602459]Phase 2418 participants (Actual)Interventional2008-01-15Completed
Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide [NCT00006042]Phase 10 participants Interventional1999-12-31Completed
Allogeneic Peripheral Blood Progenitor Cell Transplantation in Patients With Incurable Solid Tumors: A Phase I Study [NCT00006126]Phase 10 participants (Actual)Interventional1999-09-30Withdrawn(stopped due to Unable to accrue subjects.)
Minimal Ablation and Cellular Immune Therapy of Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Low-Grade Non-Hodgkin's Lymphoma, and Mantle Cell Lymphoma With Allogeneic Donor Stem Cells [NCT00006252]Phase 247 participants (Actual)Interventional2001-02-28Completed
Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia [NCT00006379]Phase 258 participants (Actual)Interventional2000-06-30Completed
Gemtuzumab Ozogamicin (GO), Fludarabine, And Low-Dose TBI Followed By Donor Stem Cell Transplantation For Patients With Advanced Acute Myeloid Leukemia Or Myelodysplastic Syndrome [NCT00008151]Phase 20 participants Interventional2000-10-31Completed
Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation [NCT00008307]Phase 252 participants (Anticipated)Interventional1998-04-30Active, not recruiting
A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide [NCT00389506]0 participants (Actual)Interventional2006-09-30Withdrawn
Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation Following Reduced Intensity Conditioning in Treating Patients With Multiple Myeloma [NCT00802568]Phase 248 participants (Anticipated)Interventional2007-04-30Completed
Phase I Study of Escalating Doses of Radiation Therapy Using Helical Tomotherapy in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) Transplantation in Patients With Advanced and [NCT00800150]Phase 16 participants (Actual)Interventional2008-11-30Terminated(stopped due to Protocol objective could not be met. A new study with amended eligibility criteria will be developed.)
Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Non-Myeloablative Preparative Regimen [NCT00719849]Phase 213 participants (Actual)Interventional2005-11-30Terminated(stopped due to A new protocol was developed to replace this protocol in 2008, with removal of ATG and extension of MMF duration.)
Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia [NCT00274846]Phase 221 participants (Actual)Interventional2005-03-31Completed
A Phase II Study of R-FND, Followed by Zevalin Radioimmunotherapy, and Subsequent Maintenance Rituximab for Advanced Stage Follicular Lymphoma With High-Risk Features [NCT00290511]Phase 249 participants (Actual)Interventional2004-06-29Completed
A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies [NCT00429416]Phase 1/Phase 214 participants (Actual)Interventional2004-03-31Completed
Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis [NCT01047072]Phase 20 participants (Actual)InterventionalWithdrawn
Timed Sequential Busulfan and Post Transplant Cyclophosphamide for Allogeneic Transplantation [NCT02861417]Phase 2204 participants (Actual)Interventional2016-08-05Active, not recruiting
Treatment of Patients With Metastatic Melanoma Using a Transplant of Autologous Lymphocytes Reactive With Tumor Following a Myeloablative Lymphocyte Depleting Regimen of Chemotherapy, Total Body Irradiation and Reconstitution With CD34+ Cells [NCT00096382]Phase 234 participants (Actual)Interventional2004-09-30Completed
Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL) [NCT00506129]Phase 233 participants (Actual)Interventional2003-09-30Completed
Conditioning for Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies [NCT01056614]Phase 223 participants (Actual)Interventional2004-09-30Completed
Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen [NCT00309842]Phase 2213 participants (Actual)Interventional2005-07-28Completed
Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia [NCT00499889]Phase 242 participants (Actual)Interventional2003-02-28Terminated(stopped due to Support issue.)
Fludarabine, Cyclophosphamide, Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia [NCT00448019]Phase 264 participants (Actual)Interventional2007-02-28Completed
Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma [NCT00243009]Phase 21 participants (Actual)Interventional2005-06-30Terminated(stopped due to Due to a lack of a referal base, study was terminated.)
A Study of Low-dose Lenalidomide After Non-myeloablative Allogeneic Stem Cell Transplant With Bortezomib as GVHD Prophylaxis in High Risk Multiple Myeloma [NCT01954784]Phase 18 participants (Actual)Interventional2013-10-07Terminated(stopped due to Funding unavailable)
Personalized NK Cell Therapy in CBT [NCT02727803]Phase 2100 participants (Anticipated)Interventional2016-05-19Recruiting
A Phase I/IIa, Open-label, Non-randomized, Study of ASC-101 in Patients With Hematologic Malignancies or Myelodysplastic Syndrome (MDS) Who Are Candidates for Dual-cord Umbilical Cord Blood Transplantation (UCBT) [NCT01983761]Phase 1/Phase 225 participants (Anticipated)Interventional2013-11-30Active, not recruiting
Pilot Study of Crenolanib Combined With Standard Salvage Chmetherapy in Subjects With Relapsed/Refractory Acute Myeloid Leukemia [NCT02626338]Phase 1/Phase 216 participants (Actual)Interventional2016-02-29Completed
Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy an [NCT00565981]Phase 210 participants (Actual)Interventional2004-03-31Completed
MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions [NCT02582775]Phase 217 participants (Actual)Interventional2016-03-31Completed
Phase I Study of Bortezomib With or Without Total Marrow Irradiation (TMI) Using Intensity Modulated Radiation Therapy (IMRT) in Combination With Fludarabine (FLU) and Melphalan (MEL) as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) T [NCT01163357]Phase 118 participants (Actual)Interventional2011-01-28Active, not recruiting
Allogeneic Transplantation Using Mini-Conditioning for Treatment of Stage IV Breast Cancer [NCT00006261]Phase 20 participants (Actual)Interventional2000-05-31Withdrawn
Phase I/II Study of HLA-Matched Non-Myeloablative Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation as Treatment for Patients With Metastatic Renal Cell Carcinoma. A Multi-Center Trial. [NCT00005851]Phase 1/Phase 211 participants (Actual)Interventional2000-02-29Completed
Protocol for Patients With High Risk (Resistant, Refractory, Relapsed or Adverse Cytogenetic) AML [NCT00005863]Phase 30 participants Interventional1998-08-31Completed
Phase II Pilot Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low Dose TBI and Post-Transplant Cyclosporine and Mycophenolate Mofetil Followed by Donor Lymphocyte Infusion for Therapy of Advanced [NCT00005941]Phase 20 participants Interventional1999-11-30Completed
A Phase I Pilot Trial to Evaluate the Toxicity of Epstein-Barr Virus Specific T-Lymphocytes or Peripheral Blood Mononuclear Cells for the Treatment of Relapsed/Refractory Hodgkin's Disease [NCT00006100]Phase 10 participants Interventional2000-04-30Active, not recruiting
Randomized Trial of MCD Versus FMD in Untreated Advanced Follicular Lymphoma [NCT00006250]Phase 3500 participants (Anticipated)Interventional2000-05-31Active, not recruiting
A Phase I/II Study of Fludarabine, Cyclophosphamide, Rituximab, and Vorinostat Followed by Rituximab and Vorinostat Maintenance Therapy in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) [NCT00918723]Phase 1/Phase 240 participants (Actual)Interventional2009-06-30Completed
Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma [NCT00577161]Phase 30 participants (Actual)Interventional2007-09-30Withdrawn(stopped due to closed to enrollment)
Allogeneic Stem Cell Transplantation for Myelofibrosis and Myelodysplastic Syndrome Using Reduced Intensity Busulfan and Fludarabine Conditioning [NCT00475020]Phase 263 participants (Actual)Interventional2006-01-04Completed
Allogeneic Hematopoietic Cell Transplantation to Correct the Biochemical Defect and Create Tolerance to Donor Tissue in Subjects With Epidermolysis Bullosa [NCT00478244]7 participants (Actual)Interventional2007-04-30Terminated(stopped due to Competing studies)
A Phase I/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of HY004 in Adult Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL) [NCT06009107]Phase 1/Phase 250 participants (Anticipated)Interventional2023-10-18Not yet recruiting
Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressing Autologous T Cells as an Immunotherapy for Children With Solid Tumors (CARE) [NCT04715191]Phase 124 participants (Anticipated)Interventional2024-01-03Not yet recruiting
Transplantation Using Reduced Intensity Approach for Patients With Sickle Cell Disease From Mismatched Family Donors of Bone Marrow [NCT02757885]Phase 210 participants (Actual)Interventional2019-07-10Completed
A Phase 1/2 Single-center Study Evaluating the Safety and Efficacy of TRAC and Power3 Genes Knock-out Allogeneic CD19-targeting CAR-T Cell (ATHENA) Therapy in Adults With Refractory/Relapsed B-cell Non-Hodgkin Lymphoma [NCT06014073]Phase 1/Phase 230 participants (Anticipated)Interventional2023-09-06Recruiting
Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults [NCT03779854]Phase 268 participants (Anticipated)Interventional2019-08-29Recruiting
Phase I Study of Escalating Doses of Total Marrow and Lymphoid Irradiation (TMLI) During Conditioning for HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Myelodysplasia or Acute Leukemia [NCT02446964]Phase 124 participants (Anticipated)Interventional2015-06-25Active, not recruiting
Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With CD123+ Relapsed/Refractory Acute Myeloid Leukem [NCT02159495]Phase 131 participants (Actual)Interventional2015-12-15Active, not recruiting
A Prospective Study of Optimal Cord Selection for Haplo-Cord Transplantation: Targeting the Inherited Paternal Antigen (IPA) and Matching for the Non-Inherited Maternal Antigen (NIMA) [NCT01810588]Phase 2273 participants (Actual)Interventional2012-10-16Active, not recruiting
Reduced Intensity Conditioning With Fludarabine and Busulfan Versus Fludarabine and Melphalan Before Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Randomised, Single-Center, Phase III Study [NCT05674539]Phase 3200 participants (Anticipated)Interventional2022-12-28Recruiting
MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer [NCT00652899]Phase 214 participants (Actual)Interventional2008-03-31Terminated(stopped due to Withdrawn due to toxicity)
Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 TCR-Gene Engineered Lymphocytes [NCT00670748]Phase 245 participants (Actual)Interventional2008-05-29Terminated(stopped due to A more highly selected protocol with ESO TCR opened for pts with melanoma)
Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies [NCT03642626]240 participants (Anticipated)Observational2018-12-18Recruiting
A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients. [NCT00727415]Phase 1/Phase 242 participants (Actual)Interventional2008-02-29Completed
Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies [NCT02718755]Phase 20 participants (Actual)Interventional2018-05-31Withdrawn(stopped due to Problem with drug supply)
Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52 [NCT00505921]Phase 227 participants (Actual)Interventional2003-03-31Terminated(stopped due to Slow Accrual.)
A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia [NCT05761171]Phase 278 participants (Anticipated)Interventional2023-11-20Recruiting
IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome [NCT04205838]Phase 236 participants (Anticipated)Interventional2020-03-04Recruiting
NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With Nivolumab PD-1 Blockade [NCT02775292]Phase 11 participants (Actual)Interventional2017-01-03Completed
Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning For Patients With Hematological Malignancies [NCT00627666]Phase 252 participants (Anticipated)Interventional2003-01-31Completed
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of FP253 in Combination With Fludarabine Phosphate [NCT00625430]Phase 118 participants (Anticipated)Interventional2008-03-31Recruiting
Nonmyeloablative Stem Cell Transplantation With or Without Lenalidomide for Chronic Lymphocytic Leukemia (RV-CLL-PI-0294) [NCT00899431]Phase 239 participants (Actual)Interventional2009-05-06Terminated(stopped due to Terminated per PI's request at the time of continuing review)
Graft-versus-host Disease Prophylaxis With Post-transplantation Cyclophosphamide and Ruxolitinib in Patients With Myelofibrosis [NCT02806375]Phase 1/Phase 220 participants (Actual)Interventional2016-01-31Completed
A Randomized Phase III Trial Comparing the Combination of Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) With the Combination of Fludarabine and Rituximab (F-R) in the Treatment of Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymph [NCT00551239]Phase 30 participants (Actual)Interventional2007-08-31Withdrawn
A Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL [NCT00185445]Phase 262 participants (Actual)Interventional2004-06-30Completed
Treatment of Patients With Metastatic Melanoma by Lymphodepleting Conditioning Followed by Infusion of TCR-Gene Engineered Lymphocytes and Subsequent Fowlpox gp100 Vaccination [NCT00085462]Phase 161 participants (Anticipated)Interventional2004-05-31Completed
A Pilot Study of Double Cord Blood Stem Cell Transplantation in Patients With Hematologic Malignancies [NCT00423826]0 participants Expanded Access2007-01-31No longer available
Phase II Trial of Non-Myeloablative Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation Using Fludarabine, Low-Dose TBI, and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil (MMF) Followed by Donor Lymphocyte Infusion [NCT00006233]Phase 20 participants Interventional2000-01-31Completed
Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil [NCT00006251]Phase 1/Phase 221 participants (Actual)Interventional2000-05-31Completed
Dose-escalation Study of Graft-versus-host Disease Prophylaxis With High-dose Post-transplantation Bendamustine in Patients With Refractory Acute Leukemia [NCT02799147]Phase 1/Phase 227 participants (Actual)Interventional2016-06-30Completed
A Randomized Phase II Trial of Fludarabine, Cyclophosphamide and Mitoxantrone (FCM) With or Without Rituximab in Previously Treated Chronic Lymphocytic Leukemia [NCT00337246]Phase 256 participants (Anticipated)Interventional2005-07-31Completed
A Multicenter Study to Confirm the Efficacy and Safety of Fludara i.v. (Fludarabine Phosphate, SH L 573), Administered in 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by an Observation Period of 23 Days) in Untreated Chronic L [NCT00220311]Phase 410 participants (Actual)Interventional2000-11-30Completed
A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies [NCT00782379]Phase 220 participants (Actual)Interventional2008-10-31Completed
"High Dose Interleukin-2 (IL-2) Therapy In Lymphodepleted Primed Patients With Metastatic Melanoma" [NCT00085423]Phase 220 participants (Actual)Interventional2004-02-29Completed
Haploidentical Donor NK Cell Adoptive Therapy and Double T Cell Depleted Umbilical Cord Blood Transplantation With Post-Transplant IL-2 Immune Therapy For Refractory Acute Myeloid Leukemia [NCT00871689]Phase 22 participants (Actual)Interventional2009-01-31Terminated(stopped due to Due to graft failure.)
A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies Using Melphalan for T-Cell Tolerization [NCT01350258]Phase 1/Phase 28 participants (Actual)Interventional2011-04-30Terminated(stopped due to Poor accrual)
Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies [NCT01471067]Phase 133 participants (Actual)Interventional2012-07-13Completed
Observational Study for Evaluation of Quality of Life in Patients Under Treatment for B-Chronic Lymphocytic Leukemia. [NCT00344825]300 participants (Actual)Observational2004-01-31Completed
Infusion of Allogeneic, 3rd Party CD19-specific T Cells for Patients With Refractory CD19+ B-Lineage Lymphoid Malignancies [NCT02274506]Phase 10 participants (Actual)Interventional2014-10-20Withdrawn(stopped due to PI's response to ePAAC, has withdrawn the protocol acknowledging the PI's action.)
Phase I/II Randomized Trial of Cord Blood-derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma [NCT06066359]Phase 1/Phase 244 participants (Anticipated)Interventional2023-11-30Recruiting
Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases [NCT04083183]Phase 1/Phase 240 participants (Anticipated)Interventional2020-06-16Recruiting
NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING [NCT00521430]30 participants (Anticipated)Interventional2004-04-30Completed
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation [NCT00516152]Phase 236 participants (Anticipated)Interventional2002-11-30Completed
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00098670]Phase 2102 participants (Actual)Interventional2004-10-31Completed
Rituximab For Prevention Of Acute Graft-Versus-Host Disease (GVHD) After Unrelated Donor Allogeneic Hematopoietic Cell Transplantation (HCT) [NCT01044745]Phase 220 participants (Actual)Interventional2009-12-10Terminated(stopped due to Study was closed to accrual for safety related to the frequency of BK infections.)
A PedAL/EuPAL Phase 1/2 Trial of IMGN632 in Pediatric Patients With Relapsed or Refractory Leukemia [NCT05320380]Phase 1/Phase 20 participants (Actual)Interventional2023-08-01Withdrawn(stopped due to Withdrawn per CS0150757)
Hematopoietic Stem Cell Transplantation Using Alternate Donor Umbilical Cord Blood Options [NCT01652014]Phase 20 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to Funding unavailable)
Pre-administration of Rabbit Antithymocyte Globulin to Optimize Donor T-Cell Engraftment Following Reduced Intensity Allogeneic Peripheral Blood Progenitor Cell Transplantation From Matched-Related Donors [NCT00787761]Phase 224 participants (Actual)Interventional2007-04-30Completed
Reduced Intensity Allogeneic Stem Cell Transplantation With Matched Unrelated Donors for Patients With Hematologic Malignancies [NCT00818961]Phase 236 participants (Actual)Interventional2005-05-31Terminated(stopped due to terminated early due to meeting end point with fewer patients than anticipated)
Allogeneic Hematopoietic Cell Transplantation for Patients With Nonmalignant Inherited Disorders Using a Treosulfan Based Preparative Regimen [NCT00919503]Phase 298 participants (Actual)Interventional2009-07-31Completed
Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia [NCT00002838]Phase 1/Phase 213 participants (Actual)Interventional1995-12-31Completed
Randomized Phase III Study in Low Grade Lymphoma Comparing Maintenance Anti-CD20 Antibody Versus Observation Following Induction Therapy [NCT00003204]Phase 3515 participants (Actual)Interventional1998-03-31Completed
A Phase I-II Study for the Treatment of Steroid Resistant GVHD With Fludarabine [NCT00004194]Phase 1/Phase 20 participants InterventionalActive, not recruiting
Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide [NCT00004218]Phase 30 participants Interventional1999-10-31Completed
A Study to Determine the Safety and Efficacy of Using CD8-High Density Microparticles (CD8-HDM) to Deplete CD8+ Cells From Donor Lymphocyte Infusion in Order to Reduce Graft-versus-Host Disease (GvHD) Without Compromising an Anti-Leukemia Effect in Patien [NCT00004878]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to study never opened)
Phase I Study of Bryostatin 1 (NSC 339555) and Fludarabine in Patients With Chronic Lymphocytic Leukemia and Indolent Non-Hodgkin's Lymphoma [NCT00005580]Phase 154 participants (Actual)Interventional1998-09-30Completed
Chemotherapy (CT) Followed by Donor Lymphocyte Infusion (DLI) Plus Interleukin 2 (IL-2) for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant [NCT00005802]Phase 1/Phase 20 participants Interventional1999-06-30Completed
Haploidentical Stem Cell Transplant Using Post Transplant Cyclophosphamide for GvHD Prophylaxis: A Pilot Study [NCT02248597]Phase 227 participants (Actual)Interventional2015-02-25Completed
A Phase I Trial of PS-341 and Fludarabine for Relapsed and Refractory Indolent Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia [NCT00068315]Phase 118 participants (Actual)Interventional2003-07-31Completed
A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic and Accelerated Phase [NCT00110058]Phase 240 participants (Anticipated)Interventional2005-02-28Completed
Pilot Study on Allogeneic Stem Cell Transplantation Following Conditioning With Fludarabine and an Alkylating Agent in Patients With High-Risk Chronic Lymphocytic Leukemia [NCT00281983]Phase 1/Phase 2100 participants (Actual)Interventional2000-06-30Completed
A Phase I Trial Of Sequential Administration Of Triapine (3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone) Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias [NCT00077558]Phase 10 participants Interventional2004-01-31Completed
A Cyclophosphamide/Fludarabine/Total Body Irradiation Preparative Regimen for Patients With Hematological Malignancy Receiving Unrelated Donor Umbilical Cord Blood Transplantation [NCT00290641]68 participants (Actual)Interventional2001-04-30Completed
Fludarabine and Low-Dose TBI Dose Escalation to Determine the Optimal Regimen for Achieving High Rates Engraftment of Unrelated Donor Peripheral Blood Stem Cell in Patients With Chronic Myeloid Leukemia - A Multi-Center Trial [NCT00119340]Phase 1/Phase 275 participants (Anticipated)Interventional2005-04-30Completed
Phase II Trial Comparing Combination Treatment With Fludarabine and Alemtuzumab to Fludarabine and Rituximab in Patients With B-Cell Chronic Lymphocytic Leukemia Requiring Treatment After First Line Therapy [NCT00086775]Phase 20 participants Interventional2003-07-31Completed
Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation [NCT00301912]Phase 20 participants (Actual)Interventional2002-01-31Withdrawn(stopped due to Withdrawn because study never opened to accrual)
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00301951]Phase 17 participants (Actual)Interventional2004-09-30Completed
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies [NCT00304018]Phase 15 participants (Actual)Interventional2002-10-31Completed
Low-Dose Allogeneic Peripheral Blood Stem Cell Transplantation for High-Risk Low Grade Hematologic Malignancies [NCT00296023]25 participants (Actual)Interventional1999-01-31Completed
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Mutations in GATA2 or the MonoMAC Syndrome [NCT01861106]Phase 2144 participants (Anticipated)Interventional2013-07-24Recruiting
A Study in Metastatic Melanoma Using a Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 TCR-Gene Engineered Lymphocytes and Subsequent Peptide Immunization [NCT00091104]Phase 1136 participants (Anticipated)Interventional2004-07-31Completed
A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma [NCT00091143]Phase 120 participants (Anticipated)Interventional2004-07-31Completed
The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells [NCT00084695]Phase 225 participants (Anticipated)Interventional2003-09-30Recruiting
A Phase II Pilot Study of Tumor-Loaded Dendritic Cells Alone or Following a Non-Myeloablative Conditioning Regimen in Patients With Metastatic Renal Cell Carcinoma [NCT00093522]Phase 228 participants (Anticipated)Interventional2004-08-31Active, not recruiting
A Pilot Study to Evaluate the Co-infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors With an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies [NCT00343798]Phase 123 participants (Actual)Interventional2006-04-30Completed
Alloreactive NK Cells With Busulfan, Fludarabine and Thymoglobulin for Allogeneic Stem Cell Transplantation for AML and MDS [NCT00402558]Phase 115 participants (Actual)Interventional2006-05-31Completed
Low-Dose Total Body Irradiation and Fludarabine Followed By Unrelated Donor Stem Cell Transplantation for Patients With Fanconi Anemia - A Multicenter Trial [NCT00093743]Phase 12 participants (Actual)Interventional2000-01-31Completed
Reduced Intensity Conditioning Regimen for Haplo-identical Family Donor Stem Cell Transplants for Hematologic Malignancies With Delayed Add-back of Non-alloreactive T Cells [NCT00104975]Phase 120 participants (Anticipated)Interventional2005-02-28Completed
A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome [NCT00454480]Phase 2/Phase 32,000 participants (Anticipated)Interventional2006-08-31Completed
Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders [NCT00053989]Phase 241 participants (Actual)Interventional2002-01-29Completed
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Treatment of Indolent Lymphoid Malignancies [NCT00473551]Phase 14 participants (Actual)Interventional2007-05-31Terminated(stopped due to Terminated due to slow accrual.)
Cord Blood Expansion on Mesenchymal Stem Cells [NCT00498316]Phase 198 participants (Actual)Interventional2007-07-03Completed
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS [NCT04708054]Phase 2100 participants (Anticipated)Interventional2021-10-21Recruiting
First-Line Therapy With Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA-101) (iFCG) for Patients With Chronic Lymphocytic Leukemia (CLL) With Mutated IGHV Gene and Non-Del(17p) [NCT02629809]Phase 281 participants (Actual)Interventional2016-03-18Active, not recruiting
A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With TGF-Beta Resistant (DNRII) and NGFR Transduced T-Cells Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma [NCT01955460]Phase 115 participants (Anticipated)Interventional2014-10-15Recruiting
A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia [NCT00801489]Phase 2270 participants (Anticipated)Interventional2007-04-04Recruiting
Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease [NCT00385788]Phase 252 participants (Actual)Interventional2005-07-31Completed
A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Hematopoietic Stem Cells From HLA-Compatible Related or Unrelated Donors in Patients With B Cell Lymphoid Malignancies [NCT00425802]Phase 261 participants (Actual)Interventional2006-11-28Completed
Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes [NCT00509496]Phase 221 participants (Actual)Interventional2007-06-30Terminated(stopped due to Low accrual)
Hematopoietic Cell Transplantation for Treatment of Patients With Primary Immunodeficiencies and Other Nonmalignant Inherited Disorders Using Low-Dose TBI and Fludarabine With or Without Campath® [NCT00553098]Phase 229 participants (Actual)Interventional2006-06-30Completed
Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen for Advanced/Recurrent Mantle Cell Lymphoma [NCT00525876]49 participants (Actual)Interventional2005-01-31Completed
Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 F5 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization [NCT00612222]Phase 24 participants (Actual)Interventional2008-01-31Terminated(stopped due to The study was terminated due to low accrual.)
Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis [NCT00618540]Phase 21 participants (Actual)Interventional2007-01-31Terminated(stopped due to Slow accrual)
Phase II Study of the Addition of Azacitidine (NSC#102816) to Reduced-Intensity Conditioning Allogeneic Transplantation for Myelodysplasia (MDS) and Older Patients With AML [NCT01168219]Phase 268 participants (Actual)Interventional2010-07-15Completed
Tandem Autologous HCT/Nonmyeloablative Allogeneic HCT From HLA-Matched Related and Unrelated Donors Followed by Bortezomib Maintenance Therapy for Patients With High-Risk Multiple Myeloma [NCT00793572]Phase 232 participants (Actual)Interventional2008-10-31Completed
Combined Haploidentical-Cord Blood Transplantation for Adults and Children [NCT00943800]87 participants (Actual)Interventional2006-10-09Completed
Sequential Autologous HCT / Nonmyeloablative Allogeneic HCT Using Related, HLA-Haploidentical Donors for Patients With High-Risk Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia [NCT01008462]Phase 216 participants (Actual)Interventional2010-03-18Completed
A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL) [NCT01096992]Phase 1/Phase 251 participants (Actual)Interventional2010-04-19Completed
A Feasibility Trial of Post-Transplant Infusion of Allogeneic Regulatory T Cells and Allogeneic Conventional T Cells in Patients With Hematologic Malignancies Undergoing Allogeneic Myeloablative Hematopoietic Cell Transplantation From Haploidentical-Relat [NCT01050764]Phase 1/Phase 210 participants (Actual)Interventional2009-06-30Terminated(stopped due to Safety)
Dose Escalation Trial of Cloretazine (VNP40101M) and Hematopoietic Cell Transplantation for Patients With Selected, Poor-Prognosis Hematologic Malignancies [NCT00521859]Phase 15 participants (Actual)Interventional2007-08-31Completed
Pacritinib Prior to Transplant for Patients With Myeloproliferative Neoplasms (MPN) [NCT02410551]Phase 24 participants (Actual)Interventional2015-06-15Terminated
A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas [NCT03277729]Phase 1/Phase 250 participants (Anticipated)Interventional2017-12-05Recruiting
Phase II Study of Evaluating the Efficacy of Total Marrow and Lymphoid Irradiation (TMLI) as the Conditioning Regimen for HLA-Haploidentical Hematopoietic Cell Transplantation in Patients With Myelodysplasia or Acute Leukemia [NCT04262843]Phase 270 participants (Anticipated)Interventional2020-02-07Recruiting
Bispecific NK Engager AFM13 Combined With NK Cells for Patients With Recurrent of Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas [NCT04074746]Phase 1/Phase 230 participants (Anticipated)Interventional2020-07-18Active, not recruiting
A Phase 1 Safety Study of Adoptive Cellular Therapy Using Autologous T Cells Transduced With Lentivirus to Express a CD33 Specific Chimeric Antigen Receptor in Patients With Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia [NCT03126864]Phase 111 participants (Actual)Interventional2017-08-04Terminated(stopped due to Terminated per the PI's request.)
A Phase II Trial of High-Dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-Dose Total Body Irradiation and HLA-Matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma [NCT01434472]Phase 220 participants (Actual)Interventional2011-11-16Terminated(stopped due to Terminated due to insufficient funding)
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission [NCT00101140]Phase 20 participants (Actual)InterventionalWithdrawn
A Phase I/II Combination Study of Topotecan, Fludarabine, Cytosine Arabinoside and G-CSF (T-FLAG) Induction Therapy in Patients With Poor Prognosis AML, MDS and Relapsed/Refractory ALL Followed by Maintenance of Either PBSC Transplant or 13 Cis-Retinoic A [NCT00003619]Phase 1/Phase 20 participants Interventional1998-02-28Completed
A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older [NCT00110071]Phase 138 participants (Actual)Interventional2005-01-31Completed
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants [NCT00112567]Phase 1/Phase 220 participants (Anticipated)Interventional2003-04-30Completed
A Phase I Study Combining Escalating Doses of Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to Establish Mixed or Full Donor Chimerism [NCT00008177]Phase 179 participants (Actual)Interventional1999-07-27Completed
Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer [NCT00020176]Phase 20 participants Interventional2000-06-30Completed
Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine [NCT00009984]Phase 270 participants (Actual)Interventional2002-03-31Terminated
Phase II Study of Combination Rituxan (Rituximab, Mabthera) and Fludarabine Therapy in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia) [NCT00020800]Phase 27 participants (Actual)Interventional2001-09-30Completed
Submyeloablative Allogeneic Blood Stem Cell Transplantation With HLA Identical Donor Lymphocyte Infusions From Matched Related and Matched Unrelated Donors for Treatment of Metastatic Renal Cell Carcinoma [NCT00025519]Phase 20 participants (Actual)Interventional2001-06-30Withdrawn
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Sibling Donors For Treatment Of Patients With High Risk Acute Lymphocytic Leukemia In Complete Remission [NCT00027547]Phase 1/Phase 20 participants Interventional2001-07-31Completed
Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial [NCT00027820]Phase 1/Phase 2106 participants (Actual)Interventional2001-08-31Completed
Autologous Followed By Non-Myeloablative Allogeneic Transplant For Multiple Myeloma [NCT00028600]Phase 260 participants (Actual)Interventional2001-11-30Completed
Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression [NCT00014235]160 participants (Anticipated)Interventional2000-12-31Completed
Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission [NCT00043810]Phase 1/Phase 23 participants (Actual)Interventional2002-07-31Terminated
Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis [NCT00001586]Phase 2105 participants (Actual)Interventional1997-09-30Completed
A Phase II Study of Oral Fludarabine Phosphate in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia [NCT00049075]Phase 2128 participants (Actual)Interventional2002-08-08Completed
National Mantle Cell Lymphoma Trial - Phase II Randomized Study of Fludarabine/Cyclophosphamide Combination With or Without Rituximab in Patients With Untreated Mantle Cell Lymphoma [NCT00053092]Phase 282 participants (Anticipated)Interventional2002-10-31Completed
Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes [NCT00053287]Phase 242 participants (Actual)Interventional2002-09-30Completed
Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer [NCT00056095]Phase 257 participants (Actual)Interventional2002-11-04Completed
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma [NCT00073879]0 participants Interventional2003-04-30Completed
Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen [NCT00079144]Phase 20 participants Interventional2004-01-31Completed
Phase II Trial Using Aldesleukin (IL-2) Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma [NCT00138229]Phase 26 participants (Actual)Interventional2005-07-31Terminated
Low Dose Chlorambucil Maintenance Vs. No Treatment Following High-Dose Chlorambucil Induction In Patients With Advanced B-Chronic Lymphocytic Leukemia. A Randomized Phase III Study Of The EORTC LG (CLL-3) [NCT00017108]Phase 30 participants Interventional2001-03-31Active, not recruiting
Phase II Window Evaluation of the Farnesyl Transferase Inhibitor (R115777) Followed by 13-CIS Retinoic Acid, Cytosine Arabinoside and Fludarabine Plus Hematopoietic Stem Cell Transplantation in Children With Juvenile Myelomonocytic Leukemia [NCT00025038]Phase 2100 participants (Actual)Interventional2001-06-30Completed
Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study [NCT00027573]Phase 236 participants (Actual)Interventional2001-10-31Completed
Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors [NCT00027924]Phase 20 participants Interventional2001-10-31Completed
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL) [NCT00276848]Phase 3375 participants (Actual)Interventional1999-07-31Completed
Campath 1H (Alemtuzumab) Combined With High-Dose Therapy and Autologous Stem Cell Transplantation in Chronic Lymphocytic Leukemia [NCT00276809]Phase 230 participants (Anticipated)Interventional2001-06-30Completed
Pivotal Study for High Dose Therapy and Autologous Stem Cell Transplantation in Early Stages of CLL [NCT00275015]Phase 2169 participants (Actual)Interventional1998-01-31Completed
Safety and Efficacy of Campath in Nonmyeloablative Transplantation [NCT00038844]65 participants (Actual)Interventional2001-06-30Completed
Phase I and Pharmacokinetic Study of UCN-01 and Fludarabine in Relapsed or Refractory Low-Grade Lymphoid Malignancies [NCT00019838]Phase 10 participants Interventional1999-07-31Completed
Safety and Efficacy of Sequential Treatment With a Combination of Rituximab, Fludarabine and Cyclophosphamide Followed by Zevalin (Rituximab and Y-Ibritumomab Tiuxetan) - A Phase I/II Study for Treatment of Patients With Relapsed Indolent and Transformed [NCT00397800]Phase 1/Phase 212 participants (Anticipated)Interventional2005-06-30Active, not recruiting
Randomized Study Of Fludarabine And Cyclophosphamide With Or Without Genasense (Bcl-2 Antisense Oligonucleotide) In Subjects With Relapsed Or Refractory Chronic Lymphocytic Leukemia [NCT00024440]Phase 30 participants Interventional2001-07-31Completed
Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation For Patients With Disease Relapse Or Myelodysplasia After Prior Autologous Transplantation [NCT00053196]Phase 282 participants (Actual)Interventional2002-12-31Completed
Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation [NCT00055653]Phase 20 participants Interventional2003-01-31Completed
Phase II Trial of T-Cell Depleted Hematopoietic Stem Cell Transplants (SBA-E-BM) From HLA Compatible Related or Unrelated Donors After a Myeloablative Preparative Regimen of Hyperfractionated TBI, Thiotepa and Cyclophosphamide (TBI/Thio/cy) for Treatment [NCT00028730]Phase 225 participants (Actual)Interventional2001-08-31Completed
A Phase I Study of Flavopiridol, Fludarabine and Rituximab in Indolent B-cell Lymphoproliferative Disorders and Mantle Cell Lymphoma [NCT00058227]Phase 137 participants (Actual)Interventional2003-04-30Completed
Nonmyeloablative Allogeneic Hematopoietic Cell Transplantation From HLA Matched Unrelated Donors for Treatment of Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission - A Multicenter Trial [NCT00031655]Phase 230 participants (Anticipated)Interventional2001-09-30Completed
Pilot Study Of T-Cell-Depleted Peripheral Blood Stem Cell Transplantation From Partially Matched Related Donors For Patients With High-Risk Leukemia [NCT00066417]Phase 251 participants (Anticipated)InterventionalTerminated(stopped due to Trial was withdrawn for drug availability issues.)
Phase I/II Evaluation of Safety and Activity of Mylotarg Plus Melphalan and Fludarabine as Preparative Therapy for Older or Medically Infirm Patients Undergoing Allogeneic Bone Marrow and Peripheral Blood Stem Cell Transplantation [NCT00038831]Phase 1/Phase 247 participants (Actual)Interventional2001-05-31Completed
Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies [NCT00068523]10 participants (Actual)Interventional2003-06-30Completed
A Phase II Multicenter Randomized Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And Chronic Lymphocytic Leukemia (CLL) [NCT00041288]Phase 210 participants (Actual)Interventional2001-10-31Terminated(stopped due to Poor accrual and difficulty with multicenter logistics)
Prolonged Mycophenolate Mofetil and Truncated Cyclosporine Postgrafting Immunosuppression to Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Maligna [NCT00078858]Phase 1/Phase 237 participants (Actual)Interventional2003-09-30Completed
Low Dose Total-Body Irradiation And Fludarabine Followed By HLA Matched Allogeneic Stem Cell Transplantation For Hematologic Malgnancies - A Multi-Center Study [NCT00044954]Phase 20 participants Interventional1999-11-30Completed
A Phase II Study of Single Agent Depsipeptide (NSC 630176) Followed by a Phase I Study of Rituximab/Fludarabine Combination With an Escalating Dose of Depsipeptide in Relapsed or Refractory Low Grade B Cell Lymphomas [NCT00079443]Phase 260 participants (Actual)Interventional2004-01-31Terminated
T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies [NCT00080925]Phase 120 participants (Anticipated)Interventional2004-02-29Completed
Pilot Study Of Multiple Umbilical Cord Blood Unit Transplantation Following Non-Myeloablative Conditioning In Patients With Hematologic Disorders Or Severe Aplastic Anemia [NCT00054236]Phase 155 participants (Actual)Interventional2002-05-31Completed
Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma [NCT00045513]Phase 1/Phase 20 participants Interventional2002-06-30Completed
Pilot/Feasibility Study To Evaluate The Safety Of Cellular Immunotherapy For CD19+ Follicular Lymphoma Using Autologous Cytolytic T Cells Genetically-Modified To Be CD19-Specific And Co-Express HyTK [NCT00182650]Phase 15 participants (Anticipated)Interventional2004-06-30Completed
A Trial of Reduced Intensity Conditioning and Transplantation of Haplotype Mismatched and KIR Class I Epitope-Mismatched Highly Purified CD34 Cells [NCT00085449]Phase 1/Phase 20 participants (Actual)Interventional2006-05-31Withdrawn(stopped due to Funding cut, no patients enrolled)
Tumor Infiltrating Lymphocytes (TIL Cells) Transduced With An Interleukin-2 (SBIL-2) Gene Following The Administration Of A Nonmyeloablative But Lymphocyte Depleting Regimen in Metastatic Melanoma [NCT00062036]Phase 1/Phase 233 participants (Anticipated)Interventional2003-06-30Completed
Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Cen [NCT00397813]Phase 277 participants (Actual)Interventional2006-01-31Completed
HLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting Cyclophosphamide [NCT00358657]Phase 214 participants (Actual)Interventional2006-05-24Terminated(stopped due to Low accrual)
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Ineligible or Inappropriate for Treatment With a More Intensive Therapeutic Regimen [NCT00448201]Phase 271 participants (Actual)Interventional2011-01-07Completed
Allogeneic Hematopoietic Cell Transplantation for Patients With Hematologic Disorders Who Are Undergoing Dose-Adjusted Treatment With A Maximally Intensive Busulfex-Based Therapeutic Regimen [NCT00448357]Phase 1/Phase 254 participants (Actual)Interventional2005-10-31Completed
Phase I Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies [NCT03241940]Phase 150 participants (Anticipated)Interventional2017-10-20Recruiting
Phase 1 Dose Escalation Study of CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies [NCT03233854]Phase 160 participants (Anticipated)Interventional2017-09-01Recruiting
A Non-Myeloablative Conditioning Regimen With Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With B Cell Lymphoid Malignancies [NCT00387959]Phase 217 participants (Actual)Interventional2006-07-31Completed
Phase I/II Trial of Fludarabine in Combination With Intravenous Busulfan and Allogeneic Progenitor Cell Support for Patients With Hematologic Malignancies [NCT00506857]Phase 1/Phase 282 participants (Actual)Interventional2003-11-30Completed
Transplantation of Haploidentical CD34+ Purified Peripheral Blood Stem Cells With NK-Cell Add-Back Following Conditioning With Total Body Irradiation, Thiotepa, Fludarabine and OKT3 [NCT00450983]Phase 21 participants (Actual)Interventional2006-12-31Terminated
A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma [NCT00505895]Phase 252 participants (Actual)Interventional2002-01-31Completed
MT2007-12 Allogeneic Natural Killer Cells With Rituximab in Patients With CD20 Positive Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. Strategies to Increase Sensitivity of CLL Tumor Cells to Natural Killer Cell-Immune-Mediated Cytolysis [NCT00625729]Phase 1/Phase 26 participants (Actual)Interventional2008-01-31Terminated(stopped due to No patients exhibited natural killer cell expansion (primary endpoint).)
Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis [NCT00622895]Phase 1/Phase 23 participants (Actual)Interventional2006-09-01Completed
Busulfan (IV) and Fludarabine Followed by Post-allogeneic Transplantation Cyclophosphamide for Graft-versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies. [NCT00800839]Phase 256 participants (Actual)Interventional2008-09-30Completed
Allogeneic Hematopoietic Stem Cell Transplantation For Severe Osteopetrosis [NCT00775931]Phase 2/Phase 37 participants (Actual)Interventional2008-08-31Completed
Transplantation of Two Partially Matched Umbilical Cord Blood Units Following Reduced Intensity Conditioning to Enhance Engraftment and Limit Transplant-Related Mortality in Adults With Hematologic Malignancies [NCT00827099]Phase 25 participants (Actual)Interventional2006-06-30Terminated(stopped due to Unacceptable morbidity & mortality)
"A Feasibility Study of Early Allogeneic Hematopoietic Cell Transplantation for Relapsed or Refractory High-Grade Myeloid Neoplasms" [NCT02756572]Phase 230 participants (Actual)Interventional2016-09-22Completed
Open-label Phase I, Multi-center Study to Determine the Recommended Dose of CYAD-211 After a Non-myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients With Relapsed or Refractory Disease [NCT04613557]Phase 118 participants (Actual)Interventional2020-11-16Active, not recruiting
Phase 1/2, Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer [NCT03754933]Phase 1/Phase 210 participants (Anticipated)Interventional2019-02-11Recruiting
A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With T -Cells Transduced With CXCR2 and NGFR Followed by High Dose Interleukin-2 in Patients With Metastatic Melanoma [NCT01740557]Phase 1/Phase 210 participants (Actual)Interventional2015-01-28Completed
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML [NCT01861002]Phase 115 participants (Actual)Interventional2013-05-22Completed
Hematopoietic Stem Cell Transplant for Sickle Cell Disease [NCT02065596]Phase 1/Phase 225 participants (Anticipated)Interventional2015-10-19Completed
Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation [NCT02960646]Phase 111 participants (Actual)Interventional2017-01-18Completed
A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome [NCT02212561]Phase 119 participants (Actual)Interventional2014-08-31Completed
A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma [NCT00119392]Phase 242 participants (Actual)Interventional2004-06-30Completed
First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL) [NCT00278265]Phase 212 participants (Actual)Interventional2005-06-30Terminated(stopped due to slow recruitment)
Purine Analog-Based Conditioning for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia [NCT00427336]9 participants (Actual)Interventional2000-12-31Completed
Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity [NCT00281892]Phase 397 participants (Actual)Interventional2004-09-30Completed
Phase II Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients With B-PLL [NCT00281931]Phase 221 participants (Anticipated)Interventional1999-09-30Terminated
Nonmyeloablative Bone Marrow Transplants in Hematologic Malignancies: Dose Finding Study for Post-Transplant Immunosuppression [NCT00255710]Phase 160 participants (Anticipated)Interventional2002-07-31Completed
Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma [NCT00262886]Phase 235 participants (Anticipated)Interventional2001-08-31Completed
Stem Cell Enriched, T Cell Depleted Haplocompatible Peripheral Blood Transplantation for Children With Myelodysplastic Disease, Leukemia, Marrow Failure Syndromes, or Severe Immunodeficiency Diseases [NCT00295971]Phase 121 participants (Actual)Interventional2005-04-30Completed
Feasibility of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation Followed by Donor Lymphocyte Infusions for Children at High Risk for Complications With Conventional Transplantation [NCT00301860]8 participants (Actual)Interventional2003-01-31Terminated(stopped due to lack of efficacy)
Consolidation With Campath-1H After FMC Induction in Patients With T-cell Chronic Lymphocytic Leukemia [NCT00278213]Phase 217 participants (Anticipated)Interventional2002-09-30Completed
Phase I/Ib Study of Adoptive NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Reactive Against the NY-ESO-1-specific Cord Blood-derived NK Cells (NY-ESO-1 TCR/IL-15 NK) in Conjunction With Lymphodepleting Chemotherapy for the Management of Advance [NCT06083883]Phase 144 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia [NCT00295997]35 participants (Anticipated)Interventional2005-05-31Active, not recruiting
A Phase II Study Using a Peptide Vaccine With or Without Aldesleukin Following a Lymphodepleting Chemotherapy and Reinfusion of Autologous Lymphocytes Depleted of T Regulatory Lymphocytes in Metastatic Melanoma [NCT00303836]Phase 258 participants (Actual)Interventional2005-11-30Terminated
Bone Marrow Stem Cell Transplantation for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myeloid Leukemia in 1Remission [NCT00305708]Phase 1/Phase 240 participants (Anticipated)Interventional2000-08-31Completed
A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral [NCT00311129]Phase 241 participants (Actual)Interventional2005-12-31Completed
A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines With Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma [NCT00313508]Phase 118 participants (Actual)Interventional2006-02-28Completed
Campath (Alemtuzumab) Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class II Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies: A Multicenter Trial [NCT00118352]Phase 212 participants (Actual)Interventional2005-03-31Completed
A Phase I Study of 90Y-BC8-DOTA Monoclonal Antibody, Fludarabine and TBI Followed by HLA-Matched, Allogeneic Peripheral Blood Stem Cell Transplant for the Treatment of Multiple Myeloma [NCT01503242]Phase 115 participants (Actual)Interventional2012-01-09Completed
Natural Killer Cells in Allogeneic Cord Blood Transplantation [NCT01619761]Phase 113 participants (Actual)Interventional2013-05-03Active, not recruiting
Autologous CD19 Specific T-cell Infusion in Patients With B-cell Chronic Lymphocytic Leukemia (B-CLL) [NCT01653717]Phase 130 participants (Anticipated)Interventional2013-06-11Completed
Phase I Trial of Fludarabine and Methoxyamine (TRC102) for Relapsed or Refractory Hematologic Malignancies [NCT01658319]Phase 120 participants (Actual)Interventional2011-05-31Completed
Use of Umbilical Cord Blood Cell in the Preparative Regimen of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT00427557]Phase 231 participants (Actual)Interventional2006-10-31Completed
Dose Escalation Study Phase I/II of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction With Lymphodepleting Chemotherapy in Patients With Relapsed/Refractory B-Lymphoid Malignancies [NCT03056339]Phase 1/Phase 244 participants (Actual)Interventional2017-06-21Completed
An Open-label Phase II Study of the Efficacy and Safety of the Combination of Fludarabine, Cyclophosphamide and Rituximab in Patients With Chronic Lymphocytic Leukaemia Who Are Newly Diagnosed, Have Relapsed or Are Resistant to First-Line Treatment [NCT00812669]Phase 252 participants (Actual)Interventional2008-08-18Completed
A Phase I/II Study Evaluating the Safety and Efficacy of Adding a Single Prophylactic Donor Lymphocyte Infusion (DLI) of Natural Killer Cells Early After Nonmyeloablative, HLA-Haploidentical Hematopoietic Cell Transplantation - A Multi Center Trial [NCT00789776]Phase 1/Phase 241 participants (Actual)Interventional2008-10-13Completed
Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Chemotherapy (FLAG) in Patients With AML or Acute Leukemia of Ambiguous Lineage [NCT01701323]Phase 17 participants (Actual)Interventional2012-12-10Terminated
A Phase II Study of Myeloablative and Reduced-Intensity Conditioning Regimens for Children and Young Adults With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Stem Cell Transplantation [NCT02626715]Phase 222 participants (Actual)Interventional2015-09-04Completed
A Phase I/II Clinical Trial Testing the Safety and Feasibility of IL-21-Expanded Natural Killer Cells for the Induction of Relapsed/Refractory Acute Myeloid Leukemia [NCT01787474]Phase 130 participants (Actual)Interventional2014-05-19Completed
A Phase II Study Evaluating Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts From HLA-Matched Related and Unrelated Donors for Prevention of GVHD [NCT02220985]Phase 284 participants (Actual)Interventional2015-02-03Active, not recruiting
Prospective, Phase II Randomized Study to Compare Busulfan-fludarabine Reduced-intensity Conditioning (RIC) With Thiotepa-fludarabine RIC Regimen Prior to Allogeneic Transplantation of Hematopoietic Cells for the Treatment of Myelofibrosis [NCT01814475]Phase 262 participants (Actual)Interventional2011-07-31Completed
Pilot Study of Infusion of Fucosylated Regulatory T Cells to Prevent Graft Versus Host Disease [NCT02423915]Phase 15 participants (Actual)Interventional2015-07-30Completed
Allogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 Study [NCT01570348]Phase 22 participants (Actual)Interventional2012-07-17Terminated(stopped due to Annual accrual goal not met)
Allogenic CD19-targeting Chimeric Antigen Receptor γδT Cells Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma [NCT05554939]Phase 1/Phase 230 participants (Anticipated)Interventional2022-12-11Recruiting
Phase 1 Trial of Ivosidenib and FLAG Chemotherapy in Relapsed/Refractory IDH1+ Acute Myeloid Leukemia (AML) [NCT04250051]Phase 125 participants (Anticipated)Interventional2020-12-21Recruiting
A Randomized Phase III Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancie [NCT01231412]Phase 3174 participants (Actual)Interventional2010-11-30Completed
Autologous Activated T-Cells Transduced With A 3rd Generation GD-2 Chimeric Antigen Receptor And iCaspase9 Safety Switch Administered To Patients With Relapsed Or Refractory Neuroblastoma (GRAIN) [NCT01822652]Phase 111 participants (Actual)Interventional2013-08-31Active, not recruiting
Phase 1 Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma [NCT04119024]Phase 124 participants (Anticipated)Interventional2019-11-27Recruiting
Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation as Second Transplantation for Patients With Disease Relapse or Myelodysplasia After Prior Autologous Transplantation [NCT01118013]Phase 26 participants (Actual)Interventional2010-12-31Terminated
Biparental HLA Haplotype Disparate T-cell Depleted Transplants for Patients Lacking an HLACompatible Donor [NCT01598025]3 participants (Actual)Interventional2012-05-02Terminated(stopped due to Closed due to poor accrual)
A Pilot Study Using High Dose Busulfan and Bortezomib as Part of Allogeneic Transplant Conditioning Regimen for High Risk Multiple Myeloma Patients. [NCT01534143]Phase 21 participants (Actual)Interventional2012-02-29Terminated(stopped due to Data was not collected, because funding was unavailable to continue study.)
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation With Bevacizumab for Advanced Solid Tumor [NCT00523809]Phase 25 participants (Actual)Interventional2007-08-31Terminated(stopped due to Slow accrual.)
A Phase I and Expansion Cohort Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia [NCT04898894]Phase 142 participants (Anticipated)Interventional2021-11-15Recruiting
NK Cells With HLA Compatible Hematopoietic Transplantation for High Risk Myeloid Malignancies [NCT01823198]Phase 1/Phase 263 participants (Actual)Interventional2013-06-11Completed
A Phase Ib/2 Trial of Fludarabine/Melphalan/Total Body Irradiation With Post Transplant Cyclophosphamide as Graft Versus Host Disease Prophylaxis in Matched-Related and Matched-Unrelated Allogeneic Hematopoietic Cell Transplantation [NCT03192397]Phase 1/Phase 235 participants (Actual)Interventional2017-08-09Active, not recruiting
Phase I Clinical Trial of Anti-CD19/20/22 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, B-Prolymphocytic Leukemia) [NCT05418088]Phase 136 participants (Anticipated)Interventional2022-06-30Recruiting
Reduced Intensity Matched Sibling Bone Marrow Transplantation for Sickle Cell Anemia in Patients 2-30 Years Old [NCT01877837]Phase 330 participants (Actual)Interventional2011-06-30Completed
Study of CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR)-T Cells for the Treatment of Relapsed or Refractory B-Cell Lymphomas and Chronic Lymphocytic Leukemia (CD20 - Cluster of Differentiation Antigen 20) [NCT04007029]Phase 124 participants (Anticipated)Interventional2019-10-04Recruiting
A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders [NCT00544115]Phase 2260 participants (Actual)Interventional2001-10-16Active, not recruiting
Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia [NCT00281918]Phase 3817 participants (Actual)Interventional2003-07-31Completed
T-cell Therapy in Combination With Checkpoint Inhibitors for Patients With Advanced Ovarian-, Fallopian Tube- and Primary Peritoneal Cancer [NCT03287674]Phase 1/Phase 27 participants (Actual)Interventional2017-10-09Completed
Delayed Infusion of Ex Vivo Anergized Peripheral Blood Mononuclear Cells Following CD34 Selected Peripheral Blood Stem Cell Transplantation From a Haploidentical Donor for Patients With Acute Leukemia and Myelodysplasia [NCT00376480]Phase 119 participants (Actual)Interventional2005-06-30Completed
A Phase II Trial of Haploidentical Allogeneic Stem Cell Transplantation Utilizing Mobilized Peripheral Blood Stem Cells [NCT03333486]Phase 231 participants (Actual)Interventional2017-12-07Active, not recruiting
Phase II Study of Timed Sequential Busulfan in Combination With Fludarabine in Allogeneic Stem Cell Transplantation [NCT01572662]Phase 2201 participants (Actual)Interventional2012-04-11Completed
Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study [NCT00004114]Phase 10 participants (Actual)InterventionalWithdrawn(stopped due to Study never opened)
A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck [NCT00004246]Phase 116 participants (Actual)Interventional1995-06-07Completed
Nonmyeloablative Conditioning With Pre- and Post-Transplant Rituximab Followed by Related or Unrelated Donor Hematopoietic Cell Transplantation for Patients With Advanced Chronic Lymphocytic Leukemia: A Multi-Center Trial [NCT00104858]Phase 266 participants (Actual)Interventional2004-12-31Completed
Phase I, Open-label Study Evaluating the Safety of Escalating Doses of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally With Co-administration of Fludarabine Phosphate Intravenously) in Subjects With Advanced Solid Tumors [NCT01310179]Phase 112 participants (Actual)Interventional2011-02-28Completed
A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation [NCT01427881]Phase 243 participants (Actual)Interventional2011-09-30Completed
Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathy Using a Preparative Regimen to Achieve Stable Mixed Chimerism [NCT00176852]Phase 2/Phase 322 participants (Actual)Interventional2002-06-30Completed
A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL) [NCT01082939]Phase 280 participants (Actual)Interventional2002-12-31Completed
Allogeneic Stem Cell Transplant With a Novel Conditioning Therapy Using Helical Tomotherapy, Melphalan, and Fludarabine in Hematological Malignancies [NCT00544466]Phase 1/Phase 275 participants (Actual)Interventional2006-07-31Active, not recruiting
CAR- PRISM (PRecision Intervention Smoldering Myeloma): A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in High-Risk Smoldering Myeloma [NCT05767359]Phase 220 participants (Anticipated)Interventional2023-04-19Recruiting
A Phase II Study Of Allogeneic Transplant For Older Patients With AML In First Morphologic Complete Remission Using A Non-Myeloablative Preparative Regimen [NCT00070135]Phase 2121 participants (Actual)Interventional2004-01-31Completed
Donor Statin Treatment for Prevention of Severe Acute GVHD After Nonmyeloablative Hematopoietic Cell Transplantation [NCT01527045]Phase 247 participants (Actual)Interventional2012-09-25Completed
A Multi-Center Study of Nonmyeloablative Conditioning With TBI or Fludarabine/TBI for HLA-matched Related Hematopoietic Cell Transplantation for Treatment of Hematologic Malignancies With Post Grafting Immunosuppression With Tacrolimus and Mycophenolate M [NCT00089011]Phase 2150 participants (Actual)Interventional2004-04-30Completed
A Phase I Study to Evaluate Safety, Feasibility and Immunologic Response of Adoptive T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Metastatic Melanoma [NCT01946373]Phase 120 participants (Anticipated)Interventional2013-10-31Recruiting
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies [NCT00048737]Phase 1/Phase 270 participants (Actual)Interventional2002-10-31Completed
A Multicenter Phase I-II Study of Tumor Vaccine Following Chemotherapy in Patients With Metastatic Breast Cancer Untreated With Chemo/Radiation in the Previous 18 Months: Vaccine-Induced Bias of T-Cell Repertoire Reconstitution After T-Cell Re-Infusion [NCT00048893]Phase 1/Phase 237 participants (Actual)Interventional2002-11-30Terminated(stopped due to The study was closed to accrual due to very poor enrollment.)
A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning fo [NCT00105001]Phase 2210 participants (Actual)Interventional2004-11-30Completed
Reduced-Intensity Allogeneic HSC Transplantation From HLA-Matched Related and Unrelated Donors for Patients With Multiple Myeloma - A Multi-Center Trial [NCT00054353]Phase 1/Phase 216 participants (Actual)Interventional2002-10-31Completed
Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation From HLA Matched Related Donors for Treatment of Older Patients With De Novo or Secondary Acute Myeloid Leukemia in First Complete Remission [NCT00045435]Phase 217 participants (Actual)Interventional2002-04-30Completed
Phase I Clinical Trial of TSA-CTL (Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes) In the Treatment of Advanced Solid Tumors [NCT02959905]Phase 111 participants (Actual)Interventional2016-12-22Completed
Megadose CD34 Selected Progenitor Cells for Transplantation in Patients With Advanced Hematological Malignant Diseases [NCT00038857]Phase 229 participants (Actual)Interventional2001-09-30Completed
Adoptive Transfer of ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) in Combination With Lymphodepletion and Anti-PD-1 to Patients With Metastatic Melanoma [NCT04904185]Phase 112 participants (Anticipated)Interventional2021-08-17Recruiting
A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies [NCT01384513]Phase 240 participants (Actual)Interventional2011-08-04Completed
A Pilot Study of Post-transplant High Dose Cyclophosphamide (PTCY) as Part of Graft-Versus-Host Disease (GVHD) Prophylaxis in T-Cell Replete HLA-Mismatched Unrelated Donor (MMUD) Ablative and Reduced Intensity Hematopoietic Cell Transplantation (HCT) for [NCT03128359]Phase 238 participants (Actual)Interventional2017-05-30Active, not recruiting
A Phase II Investigation of Vorinostat in Combination With Intravenous Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT01578343]Phase 220 participants (Actual)Interventional2012-06-30Terminated(stopped due to we collected data of a total of 19 patients for an interim analysis. but there are less than 7 responses out of the initial 19 patients.)
Allogeneic Nonmyeloablative Hematopoietic Stem Cell Transplant for Patients With BCR-ABL Tyrosine Kinase Inhibitor Responsive Ph+ Acute Leukemia ? A Multi-center Trial [NCT00036738]Phase 228 participants (Actual)Interventional2001-07-13Completed
Non-Myeloablative Conditioning and Unrelated Umbilical Cord Blood Transplantation for Children and Adults With Serious Oncohematologic Diseases [NCT00255684]16 participants (Actual)Interventional2003-12-31Terminated(stopped due to low accrual)
A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Bone Marrow for Patients With Hematologic Malignancies [NCT00134004]Phase 2210 participants (Actual)Interventional2004-10-31Completed
Busulfan Dose Escalation Study Based on AUC in the Setting of Busulfan/Fludarabine Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) [NCT00361140]Phase 472 participants (Actual)Interventional2005-08-31Completed
Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) After a Nonmyeloablative Conditioning Regimen, With Administration of NY-ESO-1157-165 Pulsed Dendritic Cells and Interleukin-2, in Patients With Advanced Malignancies [NCT01697527]Phase 26 participants (Actual)Interventional2012-11-02Active, not recruiting
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma [NCT00317759]Phase 112 participants (Anticipated)Interventional2003-05-31Completed
Conditioning For Hematopoietic Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in Patients With Myeloid Malignancies [NCT00346359]Phase 240 participants (Anticipated)Interventional2006-03-31Completed
Phase I Study of In Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma [NCT00324623]Phase 18 participants (Actual)Interventional2005-09-30Completed
Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies [NCT04083170]Phase 210 participants (Anticipated)Interventional2022-10-06Recruiting
Phase I/II Study of Adoptive Immunotherapy After Allogeneic HCT With Virus Specific CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Patients With Relapsed AML [NCT01640301]Phase 1/Phase 247 participants (Actual)Interventional2012-12-06Terminated(stopped due to Terminated due to slow accrual.)
A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) [NCT00002798]Phase 3880 participants (Actual)Interventional1996-08-31Completed
A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00003248]Phase 2104 participants (Actual)Interventional1998-03-31Completed
PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA [NCT00002779]Phase 234 participants (Actual)Interventional1998-02-28Completed
A Phase I Study of G3139 (NSC 683428) in Combination With Salvage Chemotherapy for Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT00004862]Phase 124 participants (Actual)Interventional1999-10-31Completed
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis [NCT00002833]Phase 253 participants (Actual)Interventional1994-10-31Completed
Induction of Mixed Hematopoietic Chimerism Using Fludarabine, Low Dose TBI , PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to be Followed by Donor Lymphocyte Infusion In Patients With Chronic Myeloid Leuke [NCT00003145]Phase 218 participants (Actual)Interventional1997-08-31Completed
Allogeneic Stem Cell Transplantation of Renal Cell Cancer and Metastatic Melanoma After Non-Myeloablative Chemotherapy [NCT00004135]Phase 219 participants (Actual)Interventional1999-02-28Completed
A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-cell CLL [NCT00003829]Phase 234 participants (Actual)Interventional1999-08-31Completed
A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia [NCT00004255]Phase 2/Phase 30 participants Interventional2000-03-31Completed
Phase I Study of Fludarabine, Carboplatin, and Topotecan for Patients With Relapsed/Refractory Acute Leukemia and Advanced Myelodysplastic Syndromes [NCT00005593]Phase 131 participants (Actual)Interventional1998-09-30Completed
Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies [NCT00281879]Phase 2200 participants (Actual)Interventional2006-02-28Terminated
Safety and Efficacy of Anti-FLT3 CAR- T Cell (TAA05 Cell Injection) in the Treatment of Relapsed/ Refractory Acute Myeloid Leukemia [NCT05445011]Phase 112 participants (Anticipated)Interventional2022-06-14Recruiting
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma [NCT05470283]Phase 130 participants (Anticipated)Interventional2022-09-07Recruiting
Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma [NCT00338377]Phase 21,230 participants (Actual)Interventional2006-02-01Active, not recruiting
CD45A-Depleted Haploidentical Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation [NCT02259348]Phase 212 participants (Actual)Interventional2014-10-31Terminated(stopped due to Investigator's decision.)
Hematopoietic Bone Marrow Transplantation for Patients With High-risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) Using Related HLA-Mismatched Donors: A Trial Using Radiolabeled Anti-CD45 Antibody Co [NCT00589316]Phase 126 participants (Actual)Interventional2007-10-05Terminated(stopped due to Terminated due to loss of funding)
A Phase II Study of Fludarabine Induction Followed by CAMPATH-1H Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia [NCT00004857]Phase 286 participants (Actual)Interventional2000-01-31Completed
Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children [NCT00003729]Phase 213 participants (Actual)Interventional1998-12-31Terminated(stopped due to low accrual)
Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial [NCT00005799]55 participants (Actual)Interventional1999-11-30Completed
Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Hematological Diseases Using a Non-Myeloablative Preparative Regimen [NCT00365287]Phase 1/Phase 2148 participants (Actual)Interventional2000-06-30Completed
Umbilical Cord Blood Transplant With Co-Infusion of T Regulatory Cells [NCT00376519]Phase 13 participants (Actual)Interventional2007-05-31Terminated(stopped due to Slow accrual)
A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia [NCT00322101]Phase 325 participants (Actual)Interventional2006-01-31Completed
Reduced Toxicity Conditioning Prior to Unrelated Cord Cell Transplantation for High Risk Myeloid Malignancies [NCT02333838]Phase 231 participants (Actual)Interventional2015-05-31Active, not recruiting
Multi-Center, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation With or Without Infusion of Off-The-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients With Hematologic Malignancies [NCT01690520]Phase 2163 participants (Actual)Interventional2012-12-11Completed
A Phase I-II Study of Oxaliplatin, Fludarabine, and Cytarabine in Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes at First Relapse With Complete Remission Duration < 1 Year [NCT00480987]Phase 1/Phase 227 participants (Actual)Interventional2007-07-31Terminated(stopped due to Lack of support.)
AML Therapy With Irradiated Allogeneic Cells [NCT02105116]6 participants (Actual)Interventional2014-02-28Terminated(stopped due to No patients were eligible to receive the experimental component of the protocol therapy.)
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations [NCT02400281]Phase 1/Phase 228 participants (Actual)Interventional2015-09-30Completed
Allogeneic Hematopoietic Stem Cell Transplantation as Initial Salvage Therapy for Patients With Primary Induction Failure Acute Myeloid Leukemia Refractory to High-Dose Cytarabine-Based Induction Chemotherapy [NCT02441803]Phase 211 participants (Actual)Interventional2015-09-14Active, not recruiting
A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS) [NCT03670966]Phase 1/Phase 230 participants (Anticipated)Interventional2019-07-10Recruiting
A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndr [NCT03128034]Phase 1/Phase 275 participants (Anticipated)Interventional2017-10-24Suspended(stopped due to Administrative - FDA Comments)
A Phase II Trial Of Autologous Stem Cell Transplant Followed By Mini-Allogeneic Stem Cell Transplant In Lieu Of Standard Allogeneic Bone Marrow Transplantation For Treatment Of Multiple Myeloma [NCT00014508]Phase 20 participants Interventional2001-11-19Completed
A Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes [NCT00502905]Phase 2200 participants (Actual)Interventional2003-10-31Completed
A Phase III Intergroup CLL Study of Asymptomatic Patients With Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation With Later Treatment in the High Risk Genetic Subset With IGVH Unmutated Disease [NCT00513747]Phase 384 participants (Actual)Interventional2008-01-31Terminated(stopped due to Insufficient accrual)
A Phase II Study of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) in High-Risk Previously Untreated Patients With CLL [NCT00525603]Phase 260 participants (Actual)Interventional2005-06-30Completed
Phase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes and ALVAC Virus Immunization [NCT00610311]Phase 23 participants (Actual)Interventional2008-01-31Terminated(stopped due to The study was terminated due to low accrual.)
A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin, as Graft-versus-Host Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation [NCT00589563]Phase 232 participants (Actual)Interventional2007-05-31Completed
MT2008-15: Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Nonmyeloablative Preparative Regimen and Priming With Complement 3a Fragment (C3a) [NCT00963872]Phase 1/Phase 231 participants (Actual)Interventional2010-03-31Terminated(stopped due to Lack of efficacy after interim analysis)
A Study of Umbilical Cord Blood-Derived Natural Killer Cells in Conjunction With Lymphodepleting Chemotherapy and Lenalidomide as Immunotherapy in Patients With Hematologic Malignancies [NCT02280525]Phase 18 participants (Actual)Interventional2015-03-05Completed
A Phase 1/2 Trial Evaluating Treatment of Emergent Graft Versus Host Disease (GvHD) With AP1903 After Planned Donor Infusions (DLIs) of T-cells Genetically Modified With the iCasp9 Suicide Gene in Patients With Hematologic Malignancies [NCT01875237]Phase 1/Phase 23 participants (Actual)Interventional2013-12-27Terminated
Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Trans [NCT05139004]Phase 112 participants (Anticipated)Interventional2022-07-19Recruiting
Phase 2 Study of Planned Donor Lymphocyte Infusion After Reduced Intensity Allogeneic Stem Cell Transplantation [NCT01518153]Phase 216 participants (Actual)Interventional2012-02-29Terminated(stopped due to Objectives not met.)
A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) [NCT01894477]Phase 2102 participants (Actual)Interventional2013-11-30Active, not recruiting
Allogeneic Hematopoietic Stem Cell Transplantation With Nonmyeloablative Conditioning for Patients With Chronic Lymphocytic Leukemia - A Multi-center Trial [NCT00060424]Phase 221 participants (Actual)Interventional2003-03-31Completed
Bone Marrow Transplantation for Non-Malignant Congenital Bone Marrow Failure Disorders [NCT00176878]Phase 2/Phase 310 participants (Actual)Interventional2000-06-30Completed
Campath® [Alemtuzumab] Dose Escalation, Low-Dose TBI and Fludarabine Followed by HLA Class I Mismatched Donor Stem Cell Transplantation for Patients With Hematologic Malignancies - A Multi-Center Trial [NCT00040846]Phase 260 participants (Actual)Interventional2001-11-30Completed
Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation [NCT00049504]Phase 253 participants (Actual)Interventional2002-01-31Completed
A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Pediatric and Adolescent-Young Adults Patients With High Risk Solid Tumors [NCT04530487]Phase 240 participants (Anticipated)Interventional2020-08-19Recruiting
A Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children [NCT01858740]Phase 220 participants (Actual)Interventional2013-12-17Completed
Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study) [NCT00121186]Phase 21 participants (Actual)Interventional2005-07-31Terminated(stopped due to poor accrual)
A Multicenter, Prospective Trial to Evaluate the Role of NK Cell KIR Epitope Mismatch on Mortality and Disease Relapse in T-Cell Depleted Hematopoietic Stem Cell Transplantation From HLA-C Mismatched, Unrelated Donors for Myeloid Malignancies [NCT00392782]Phase 224 participants (Actual)Interventional2005-07-31Terminated
Fludarabine, Cyclophosphamide, and Rituximab (FCR) Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia [NCT00381004]Phase 260 participants (Actual)Interventional2006-09-30Completed
Phase II Trial of Triapine (NSC #663249, 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbone) Plus Fludarabine (NSC #312887, Fludarabine Monophosphate) in Adults With Aggressive Myeloproliferative Disorders (MPDs) Including Chronic Myelomonocytic Leukemia (C [NCT00381550]Phase 235 participants (Actual)Interventional2006-08-31Completed
A Phase I-II Study of Oxaliplatin, Fludarabine, Cytarabine and Rituximab in Patients With Richter's Transformation, Prolymphocytic Leukemia or Refractory/Relapsed B-Cell Chronic Lymphocytic Leukemia [NCT00452374]Phase 1/Phase 248 participants (Actual)Interventional2004-11-30Completed
Nonmyeloablative Hematopoietic Cell Transplantation for Patients With Fanconi Anemia Using Alternative Marrow Donors: A Phase II Dose-Finding Study [NCT00453388]Phase 26 participants (Actual)Interventional2007-02-28Completed
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496]Phase 225 participants (Actual)Interventional2007-11-13Completed
Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes and Dendritic Cell Vaccination [NCT00704938]Phase 23 participants (Actual)Interventional2008-06-30Terminated(stopped due to Terminated due to withdrawal of support from our collaborator.)
A Phase II Study for Metastatic Melanoma Using High-Dose Chemotherapy Preparative Regimen Followed by Cell Transfer Therapy Using Tumor-Infiltrating Lymphocytes Plus IL-2 With the Administration of Pembrolizumab in the Retreatment Arm [NCT01993719]Phase 233 participants (Actual)Interventional2013-12-12Completed
Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia [NCT00003816]Phase 2/Phase 3361 participants (Actual)Interventional1998-10-19Completed
A Phase I Trial Evaluating Escalating Doses of ²¹¹At-Labeled Anti-CD38 Monoclonal Antibody Followed by HLA-Matched or Haploidentical Donor Hematopoietic Cell Transplantation for High-Risk Multiple Myeloma [NCT04579523]Phase 130 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion With Cyclophosphamide and Fludarabine for Patients With Metastatic Melanoma [NCT01807182]Phase 211 participants (Actual)Interventional2013-08-20Completed
Allogeneic Peripheral Blood Stem Cell Transplantation Using a Non-Myeloablative Preparative Regimen for Patients With Hematologic Malignancies [NCT00004145]Phase 216 participants (Actual)Interventional1998-11-30Completed
PRO#1278: A Phase III Study of Fludarabine and Busulfan Versus Fludarabine, Busulfan and Low Dose Total Body Irradiation in Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant [NCT01366612]Phase 353 participants (Actual)Interventional2010-06-16Terminated(stopped due to Lack of Accrual)
Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features [NCT00462332]Phase 286 participants (Actual)Interventional2007-05-31Completed
A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation [NCT01529827]Phase 294 participants (Actual)Interventional2012-02-28Completed
A Pilot Study of an Immunosuppressive and Myeloablative Preparative Regimen for Allogeneic Unrelated Donor Hematopoietic Stem Cell Transplantation (HSCT) for Severe Sickle Cell Disease [NCT01279616]Phase 28 participants (Actual)Interventional2010-09-30Terminated(stopped due to PI moving to a different institution.)
A Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Mult [NCT01251575]Phase 277 participants (Actual)Interventional2010-12-01Completed
Dose-Intense Yttrium-90 Ibritumomab Tiuxetan (Zevalin)-Containing Non-Myeloablative Conditioning for Allogeneic Stem Cell Transplantation in B-cell Malignancies [NCT01490723]Phase 220 participants (Actual)Interventional2013-01-31Completed
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies [NCT01499147]100 participants (Actual)Interventional2000-02-29Completed
Natural Killer (NK) Cells and Nonmyeloablative Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) [NCT01390402]Phase 26 participants (Actual)Interventional2012-01-31Completed
A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma Using a Conditioning Regimen of Fludarabine, Melphalan, and Bortezomib [NCT01453101]Phase 254 participants (Actual)Interventional2010-06-09Completed
Pre-Transplant Immunosuppression and Related Haploidentical Hematopoietic Cell Transplantation for Patients With Severe Hemoglobinopathies [NCT04776850]Early Phase 10 participants (Actual)Interventional2020-12-29Withdrawn(stopped due to Competing protocol opened in Adult SCT that will include pediatric patients and is now multi-center. No patients enrolled on study.)
Once Daily Intravenous Busulfex as Part of Reduced-toxicity Conditioning for Patients With Relapsed/Refractory Hodgkin's and Non-Hodgkin's Lymphomas Undergoing Allogeneic Hematopoietic Progenitor Cell Transplantation - A Multicenter Phase II Study [NCT01203020]Phase 222 participants (Actual)Interventional2010-10-12Completed
"A Phase I/II Clinical Trial of Off-the-shelf NK Cell Administration in Combination With Allogeneic SCT to Decrease Disease Relapse in Patients With High-risk Myeloid Malignancies Undergoing Matched Related, Matched Unrelated, One Antigen Mismatched Unrel [NCT05115630]Phase 1/Phase 224 participants (Anticipated)Interventional2022-04-08Recruiting
Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC) [NCT00723099]Phase 273 participants (Actual)Interventional2008-06-25Completed
A Phase I/II Study of Autologous Stem Cell Transplantation Followed by Nonmyeloablative Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Lymphoma - A Multi-center Trial [NCT00005803]Phase 1/Phase 276 participants (Actual)Interventional1999-09-30Completed
A Phase I/II Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Patients With Hematologic Malignancies Using Busulfan, Fludarabine and Total Body Irradiation [NCT00245037]Phase 1/Phase 2147 participants (Actual)Interventional2005-06-30Completed
A Randomized Phase II Study Comparing Two Different Conditioning Regimens Prior to Allogeneic Hematopoietic Cell Transplantation (HCT) for Children With Juvenile Myelomonocytic Leukemia (JMML) [NCT01824693]Phase 230 participants (Actual)Interventional2013-06-24Completed
Adoptive Cell Therapy Across Cancer Diagnoses [NCT03296137]Phase 1/Phase 225 participants (Actual)Interventional2017-10-13Active, not recruiting
A Pilot Study of Allogeneic Hematopoietic Cell Transplantation for Patients With High Grade Central Nervous System Malignancies [NCT04521946]Phase 10 participants (Actual)Interventional2021-01-14Withdrawn(stopped due to No participants enrolled.)
Phase 1 A/B Study of LY2606368 in Combination With Cytarabine and Fludarabine in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HRMDS) [NCT02649764]Phase 115 participants (Actual)Interventional2016-05-04Completed
Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL [NCT00090051]Phase 3552 participants (Actual)Interventional2003-07-31Completed
Allogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination Wi [NCT00112593]5 participants (Actual)Interventional1999-11-30Completed
Decitabine Followed by Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Neoplasms [NCT01707004]Phase 220 participants (Actual)Interventional2013-05-16Completed
A Phase II Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients With Advanced AML or High Risk Myelodysplastic Syndrome [NCT00119366]Phase 218 participants (Actual)Interventional2003-05-31Terminated(stopped due to Funding ended before target accrual was reached; participants are no longer being examined or receiving intervention.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00001586 (2) [back to overview]Number of Participants With Adverse Events
NCT00001586 (2) [back to overview]Change in Gene Expression Post Chemo
NCT00003659 (3) [back to overview]Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease
NCT00003659 (3) [back to overview]Overall Survival Status
NCT00003659 (3) [back to overview]Overall Response Rate
NCT00003816 (4) [back to overview]4 yr OS
NCT00003816 (4) [back to overview]Toxicity/TRM at Day 100
NCT00003816 (4) [back to overview]CR Rate
NCT00003816 (4) [back to overview]4 Year PFS
NCT00005803 (4) [back to overview]Engraftment of HLA Identical PBSC Allografts
NCT00005803 (4) [back to overview]Non-Relapse Mortality
NCT00005803 (4) [back to overview]Overall Survival (OS)
NCT00005803 (4) [back to overview]Progression Free-survival (PFS)
NCT00006184 (2) [back to overview]Number of Participants With Adverse Events
NCT00006184 (2) [back to overview]Immune Response
NCT00027560 (6) [back to overview]Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients
NCT00027560 (6) [back to overview]Acute Graft-versus-Host Disease Matched Related Patients
NCT00027560 (6) [back to overview]Extensive Chronic Graft-versus-Host Disease Matched Related Patients
NCT00027560 (6) [back to overview]Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients
NCT00027560 (6) [back to overview]Overall Survival
NCT00027560 (6) [back to overview]Overall Survival
NCT00036738 (5) [back to overview]Leukemia-free Survival
NCT00036738 (5) [back to overview]Transplant-related Mortality
NCT00036738 (5) [back to overview]Transplant-related Mortality
NCT00036738 (5) [back to overview]Relapse Free Survival
NCT00036738 (5) [back to overview]Overall Survival
NCT00038857 (1) [back to overview]Number of Participants With Absolute Neutrophil Count Engraftment
NCT00040846 (5) [back to overview]Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
NCT00040846 (5) [back to overview]Evaluate the Risk of Occurrence of Acute and Chronic GVHD
NCT00040846 (5) [back to overview]Evaluate the Risk/Incidence of Infections
NCT00040846 (5) [back to overview]Evaluate the Risk of Transplant Related Mortality.
NCT00040846 (5) [back to overview]Evaluate the Risk for Disease Progression and Relapse
NCT00043979 (14) [back to overview]Early Post Transplantation Relapse
NCT00043979 (14) [back to overview]Median Progression Free Survival
NCT00043979 (14) [back to overview]Median Time to Reach a Platelet Count of 50,000/mm(3)
NCT00043979 (14) [back to overview]Median Time to Reach Absolute Neutrophil Count of 500/mm(3)
NCT00043979 (14) [back to overview]Number of Participants With Engraftment
NCT00043979 (14) [back to overview]Toxicity
NCT00043979 (14) [back to overview]Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)
NCT00043979 (14) [back to overview]Median Survival From Date of Progression
NCT00043979 (14) [back to overview]Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant
NCT00043979 (14) [back to overview]Number of Participants to Complete Conversion to >95% Donor Chimerism
NCT00043979 (14) [back to overview]Number of Participants With Acute and Chronic GVHD
NCT00043979 (14) [back to overview]Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy
NCT00043979 (14) [back to overview]Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)
NCT00043979 (14) [back to overview]Cluster of Differentiation 4 (CD4) Reconstitution
NCT00045435 (6) [back to overview]Incidence of Acute and Chronic GVHD
NCT00045435 (6) [back to overview]Incidence of Relapse
NCT00045435 (6) [back to overview]Incidence of Rejection
NCT00045435 (6) [back to overview]Disease-free Survival-incidence of Survival Without Relapse
NCT00045435 (6) [back to overview]Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death
NCT00045435 (6) [back to overview]Overall Survival
NCT00048737 (1) [back to overview]Number of Participants With Graft Failure
NCT00048893 (1) [back to overview]Number of Participants With Adverse Events
NCT00049504 (3) [back to overview]Non-relapse-related Mortality
NCT00049504 (3) [back to overview]Incidence of Grades III-IV Acute GVHD
NCT00049504 (3) [back to overview]Donor Engraftment (Chimerism)
NCT00053989 (4) [back to overview]Acute GvHD
NCT00053989 (4) [back to overview]Day 100 TRM
NCT00053989 (4) [back to overview]OS
NCT00053989 (4) [back to overview]PFS
NCT00054353 (8) [back to overview]Incidence of Chronic (Extensive) GVHD
NCT00054353 (8) [back to overview]Engraftment
NCT00054353 (8) [back to overview]Incidence of Acute GVHD (Grades III-IV)
NCT00054353 (8) [back to overview]Response Rate
NCT00054353 (8) [back to overview]OS
NCT00054353 (8) [back to overview]Relapse Rate
NCT00054353 (8) [back to overview]PFS
NCT00054353 (8) [back to overview]Non-relapse Mortality
NCT00060424 (5) [back to overview]Rate and Types of Infections
NCT00060424 (5) [back to overview]Acute Grade II-IV GVHD and Chronic (Extensive) GVHD
NCT00060424 (5) [back to overview]Transplant-related Mortality
NCT00060424 (5) [back to overview]Rate of Relapse
NCT00060424 (5) [back to overview]Overall Survival
NCT00067002 (5) [back to overview]Rate of Chronic GVHD
NCT00067002 (5) [back to overview]Number of Participants Severity of Acute GVHD by Treatment Arm
NCT00067002 (5) [back to overview]Time To Neutrophil Engraftment
NCT00067002 (5) [back to overview]Rate of Acute Graft Versus Host Disease (GVHD)
NCT00067002 (5) [back to overview]Number of Participants With Engraftment
NCT00070135 (3) [back to overview]Non-relapse Mortality (NRM)
NCT00070135 (3) [back to overview]2 Year DFS for All Patients
NCT00070135 (3) [back to overview]2 Year Disease Free Survival In Unrelated Donor Recipient Group
NCT00074269 (7) [back to overview]Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes
NCT00074269 (7) [back to overview]Overall Survival
NCT00074269 (7) [back to overview]Progression-free Survival
NCT00074269 (7) [back to overview]Response as Measured at 12 Months Post Allografting
NCT00074269 (7) [back to overview]Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting
NCT00074269 (7) [back to overview]Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)
NCT00074269 (7) [back to overview]Number of Participants With Adverse Events
NCT00075478 (8) [back to overview]Incidence of Chronic Extensive GVHD
NCT00075478 (8) [back to overview]Incidence of Grades II-IV Acute GVHD
NCT00075478 (8) [back to overview]Incidence of Graft Rejection
NCT00075478 (8) [back to overview]Incidence of Non-relapse Mortality
NCT00075478 (8) [back to overview]Incidence of Relapse-related Mortality
NCT00075478 (8) [back to overview]Incidence of Relapse/Progression
NCT00075478 (8) [back to overview]Overall Survival
NCT00075478 (8) [back to overview]Progression-free Survival
NCT00076752 (16) [back to overview]Relapse-free Complete Clinical Response
NCT00076752 (16) [back to overview]Absolute Lymphocyte Count
NCT00076752 (16) [back to overview]Absolute Neutrophil Count
NCT00076752 (16) [back to overview]Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody
NCT00076752 (16) [back to overview]Anti-Nuclear Antibody
NCT00076752 (16) [back to overview]Anti-Smith-Ribonuclear Protein Antibody
NCT00076752 (16) [back to overview]Cluster of Differentiation 19 (CD19) + Cells
NCT00076752 (16) [back to overview]Cluster of Differentiation 3 (CD3) + Cells
NCT00076752 (16) [back to overview]Cluster of Differentiation 4 (CD4) + Cells
NCT00076752 (16) [back to overview]Cluster of Differentiation 8 (CD8) + Cells
NCT00076752 (16) [back to overview]Extractable Nuclear Antigen (ENA)
NCT00076752 (16) [back to overview]Natural Killer Cells
NCT00076752 (16) [back to overview]Platelet Count
NCT00076752 (16) [back to overview]Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
NCT00076752 (16) [back to overview]White Blood Cells
NCT00076752 (16) [back to overview]Number of Participants With Adverse Events
NCT00085423 (3) [back to overview]Number of Participants With Lymphocyte Recovery as Measured by Blood Count
NCT00085423 (3) [back to overview]Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
NCT00085423 (3) [back to overview]Time to Progression as Measured by RECIST
NCT00086580 (20) [back to overview]Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)
NCT00086580 (20) [back to overview]Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates for Time to Alternative Therapy
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates of Overall Survival Time
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II
NCT00086580 (20) [back to overview]Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV
NCT00086580 (20) [back to overview]Maximum Plasma Concentration (Cmax) of Fludarabine
NCT00086580 (20) [back to overview]Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline
NCT00086580 (20) [back to overview]Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment
NCT00086580 (20) [back to overview]Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline
NCT00086580 (20) [back to overview]Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment
NCT00086580 (20) [back to overview]Mean Systemic Clearance (CL) of Fludarabine
NCT00086580 (20) [back to overview]Participants With Minimal Residual Disease (MRD)
NCT00086580 (20) [back to overview]Total Volume of Distribution (Vss) of Fludarabine
NCT00086580 (20) [back to overview]Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)
NCT00086580 (20) [back to overview]Summary of Participants With Adverse Experiences (AEs)
NCT00089011 (8) [back to overview]Incidence of Chronic Extensive GVHD
NCT00089011 (8) [back to overview]Incidence of Grade III/IV GVHD
NCT00089011 (8) [back to overview]Incidences of Grades II-IV Acute GVHD
NCT00089011 (8) [back to overview]Incidences of Graft Rejection
NCT00089011 (8) [back to overview]Overall Survival
NCT00089011 (8) [back to overview]Rate and Duration of Steroid Use for the Treatment of Chronic GVHD
NCT00089011 (8) [back to overview]Rates of Disease Progression
NCT00089011 (8) [back to overview]Rates of Relapse-related Mortality
NCT00090051 (15) [back to overview]Number of Participants With Overall Survival (OS) Events
NCT00090051 (15) [back to overview]Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
NCT00090051 (15) [back to overview]Final Analysis: Duration of Response
NCT00090051 (15) [back to overview]Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
NCT00090051 (15) [back to overview]Disease-free Survival (DFS)
NCT00090051 (15) [back to overview]Event-free Survival (EFS)
NCT00090051 (15) [back to overview]Final Analysis: Percentage of Participants With Complete Response
NCT00090051 (15) [back to overview]Final Analysis: Time to Disease-Free Survival Event
NCT00090051 (15) [back to overview]Final Analysis: Time to Event-Free Survival Event
NCT00090051 (15) [back to overview]Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
NCT00090051 (15) [back to overview]Final Analysis: Time to Overall Survival Event
NCT00090051 (15) [back to overview]Final Analysis: Time to Progression-Free Survival Event
NCT00090051 (15) [back to overview]Overall Survival (OS)
NCT00090051 (15) [back to overview]Number of Participants With Disease-free Survival (DFS) Events
NCT00090051 (15) [back to overview]Number of Participants With Event-free Survival (EFS) Events
NCT00096018 (2) [back to overview]Duration of Response
NCT00096018 (2) [back to overview]Overall Responders (Complete and Partial Response)
NCT00096382 (2) [back to overview]Clinical Tumor Regression
NCT00096382 (2) [back to overview]Safety
NCT00098670 (5) [back to overview]Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab
NCT00098670 (5) [back to overview]2 Year Survival
NCT00098670 (5) [back to overview]2 Year Progression Free Survival
NCT00098670 (5) [back to overview]Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab
NCT00098670 (5) [back to overview]Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab
NCT00104858 (8) [back to overview]Number of Participants With Treatment-related Mortality
NCT00104858 (8) [back to overview]Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate)
NCT00104858 (8) [back to overview]Overall Survival
NCT00104858 (8) [back to overview]Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse
NCT00104858 (8) [back to overview]Rituxan Concentration
NCT00104858 (8) [back to overview]Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD
NCT00104858 (8) [back to overview]Number of Participants With Regimen-related Toxicity and Infections
NCT00104858 (8) [back to overview]Number of Participants With Relapse/Progression
NCT00105001 (5) [back to overview]Number of Participants With Grades II-IV Acute GVHD
NCT00105001 (5) [back to overview]Number of Participants Utilizing High-Dose Corticosteroids
NCT00105001 (5) [back to overview]Number of Participants Surviving Without Progression
NCT00105001 (5) [back to overview]Number of Participants Surviving Overall
NCT00105001 (5) [back to overview]Number of Non-Relapse Mortalities
NCT00112593 (6) [back to overview]Overall Survival
NCT00112593 (6) [back to overview]Death From Regimen Toxicity or Opportunistic Infection
NCT00112593 (6) [back to overview]Death From GVHD
NCT00112593 (6) [back to overview]Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin
NCT00112593 (6) [back to overview]Reconstitution of HIV-specific Immunity
NCT00112593 (6) [back to overview]Progression of HIV
NCT00118352 (6) [back to overview]Disease Progression/Relapse
NCT00118352 (6) [back to overview]Incidence of Infection
NCT00118352 (6) [back to overview]Incidence of Grade III-IV Acute GVHD
NCT00118352 (6) [back to overview]Incidence of Graft Rejection
NCT00118352 (6) [back to overview]Incidence of High-dose Corticosteroid Utilization.
NCT00118352 (6) [back to overview]Incidence of Non-relapse Mortality
NCT00119366 (3) [back to overview]Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen
NCT00119366 (3) [back to overview]Number of Participants With 100% Donor Chimerism at Day 28 and Day 84
NCT00119366 (3) [back to overview]Participant Disease Response Within 4 Weeks After Transplant
NCT00119392 (5) [back to overview]Overall and Progression-free Survival
NCT00119392 (5) [back to overview]Response Rates
NCT00119392 (5) [back to overview]Treatment Related Mortality (TRM)
NCT00119392 (5) [back to overview]Engraftment and Hematopoietic Toxicity
NCT00119392 (5) [back to overview]Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
NCT00121186 (2) [back to overview]Overall Survival
NCT00121186 (2) [back to overview]Progression-free Survival
NCT00134004 (5) [back to overview]Progression-free Survival
NCT00134004 (5) [back to overview]Relapse Rate
NCT00134004 (5) [back to overview]Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation
NCT00134004 (5) [back to overview]Graft Failure Rate
NCT00134004 (5) [back to overview]Transplant-related Mortality
NCT00176852 (15) [back to overview]Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
NCT00176852 (15) [back to overview]Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
NCT00176852 (15) [back to overview]Number of Patients Who Experienced Grade 3-5 Treatment Related Toxicity
NCT00176852 (15) [back to overview]The Incidence of Chimerism at 100 Days
NCT00176852 (15) [back to overview]Overall Survival
NCT00176852 (15) [back to overview]Overall Survival
NCT00176852 (15) [back to overview]The Incidence of Chimerism at 1 Year
NCT00176852 (15) [back to overview]The Incidence of Chimerism at 6 Months
NCT00176852 (15) [back to overview]The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)
NCT00176852 (15) [back to overview]The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)
NCT00176852 (15) [back to overview]The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)
NCT00176852 (15) [back to overview]The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)
NCT00176852 (15) [back to overview]Disease Free Survival
NCT00176852 (15) [back to overview]Disease Free Survival
NCT00176852 (15) [back to overview]Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment
NCT00176878 (6) [back to overview]Number of Patients With Chronic Graft Versus Host Disease
NCT00176878 (6) [back to overview]Number of Patients With Succcessful Engraftment After Transplantation
NCT00176878 (6) [back to overview]Number of Patients With Grade 2-4 Acute Graft Versus Host Disease
NCT00176878 (6) [back to overview]Number of Patients With Disease Recurrence
NCT00176878 (6) [back to overview]Number of Patients Alive at Three Years (Survival)
NCT00176878 (6) [back to overview]Number of Patients Alive (Survival) at 2 Years
NCT00245037 (7) [back to overview]Relapse Mortality
NCT00245037 (7) [back to overview]Acute Graft-Versus-Host Disease (aGVHD) Outcome
NCT00245037 (7) [back to overview]Progression-Free Survival
NCT00245037 (7) [back to overview]Overall Survival
NCT00245037 (7) [back to overview]Regimen-Related Toxicities
NCT00245037 (7) [back to overview]Chronic Graft-Versus-Host Disease (cGVHD) Outcome
NCT00245037 (7) [back to overview]Non-relapse Mortality
NCT00255684 (2) [back to overview]Number of Participants Who Developed Acute Graft Versus Host Disease
NCT00255684 (2) [back to overview]Number of Participants Who Survived 100 Days or Longer
NCT00258427 (8) [back to overview]Number of Participants Experiencing Relapse
NCT00258427 (8) [back to overview]Number of Participants Experiencing Overall Survival
NCT00258427 (8) [back to overview]Number of Participants Experiencing Major Infections
NCT00258427 (8) [back to overview]Number of Participants Experiencing Acute Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Acute Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Chronic Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Chronic Graft-Versus-Host Disease
NCT00258427 (8) [back to overview]Number of Participants Experiencing Graft Failure
NCT00274846 (4) [back to overview]Number of Patients With Natural Killer (NK) Cell Expansion
NCT00274846 (4) [back to overview]Overall Survival Time of Patients With Complete Remission
NCT00274846 (4) [back to overview]Number of Patients With Complete Remission
NCT00274846 (4) [back to overview]Median Time to Disease Relapse (Months)
NCT00281918 (11) [back to overview]Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
NCT00281918 (11) [back to overview]Overall Survival (OS)
NCT00281918 (11) [back to overview]Event-free Survival (EFS)
NCT00281918 (11) [back to overview]Final Analysis: Duration of Response
NCT00281918 (11) [back to overview]Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
NCT00281918 (11) [back to overview]Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
NCT00281918 (11) [back to overview]Progression-free Survival (PFS)
NCT00281918 (11) [back to overview]Final Analysis: Time to Event-free Survival Event
NCT00281918 (11) [back to overview]Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
NCT00281918 (11) [back to overview]Final Analysis: Time to Overall Survival Event
NCT00281918 (11) [back to overview]Final Analysis: Time to Progression-free Survival Event
NCT00290511 (7) [back to overview]Tolerance and Efficacy of Maintenance Therapy With Rituximab
NCT00290511 (7) [back to overview]Median Progression Free Survival
NCT00290511 (7) [back to overview]Overall Survival
NCT00290511 (7) [back to overview]Percentage of Participants With Overall Survival Rate at 10 Years
NCT00290511 (7) [back to overview]Progression Free Survival at 10 Years
NCT00290511 (7) [back to overview]Number of Participants With Time to Progression (TTP)
NCT00290511 (7) [back to overview]Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT)
NCT00301834 (5) [back to overview]Disease-free Survival With Correction of Disease at One Year Post Transplantation
NCT00301834 (5) [back to overview]Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation
NCT00301834 (5) [back to overview]Cytomegalovirus (CMV) Viral Infection and Disease Symptoms
NCT00301834 (5) [back to overview]Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation
NCT00301834 (5) [back to overview]Treatment-related Mortality at 100 Days and 1 Year Post Transplantation
NCT00303667 (9) [back to overview]Number of Patients With Graft Failure
NCT00303667 (9) [back to overview]Disease-free Survival at 1 Year
NCT00303667 (9) [back to overview]Number of Patients With Treatment-Related Mortality
NCT00303667 (9) [back to overview]Number of Patients With Disease Relapse
NCT00303667 (9) [back to overview]Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)
NCT00303667 (9) [back to overview]Incidence of Grade III-IV Acute Graft Versus Host Disease
NCT00303667 (9) [back to overview]Incidence of Chronic Graft Versus Host Disease
NCT00303667 (9) [back to overview]In Vivo Expansion of a Donor NK Cells NK Cell Product
NCT00303667 (9) [back to overview]Disease-free Survival at 6 Months
NCT00309842 (11) [back to overview]Percentage Chimerism on Day 100
NCT00309842 (11) [back to overview]Percentage Chimerism at 1 Year
NCT00309842 (11) [back to overview]Percentage Chimerism at 2 Years
NCT00309842 (11) [back to overview]Number of Participants With Neutrophil Engraftment
NCT00309842 (11) [back to overview]Number of Participants With Chronic Graft-Versus-Host Disease
NCT00309842 (11) [back to overview]Number of Participants Who Were Alive at 1 Year Transplant Overall Survival
NCT00309842 (11) [back to overview]Percentage Chimerism on Day 21
NCT00309842 (11) [back to overview]Number of Participants Who Died Due to Transplant
NCT00309842 (11) [back to overview]Number of Participants With Acute Graft-Versus-Host Disease
NCT00309842 (11) [back to overview]Number of Participants With Platelet Engraftment
NCT00309842 (11) [back to overview]Percentage Chimerism at 6 Months
NCT00322101 (6) [back to overview]Non-relapse Mortality
NCT00322101 (6) [back to overview]Overall Survival
NCT00322101 (6) [back to overview]Progression-free Survival
NCT00322101 (6) [back to overview]Donor Cell Engraftment
NCT00322101 (6) [back to overview]Incidence and Severity of Acute and Chronic Graft-vs-host Disease
NCT00322101 (6) [back to overview]Incidence of Disease Progression/Relapse
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Neutrophil Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Attained Platelet Engraftment
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Died Due to Transplant.
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 24 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
NCT00354172 (15) [back to overview]Number of Participants (Patients) Who Experienced Relapse by 12 Months
NCT00354172 (15) [back to overview]Number of Participants (Patients) With Successful Natural Killer Cell Expansion
NCT00354172 (15) [back to overview]Number of Patients Who Were Disease-free and Alive at 24 Months
NCT00354172 (15) [back to overview]Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
NCT00358657 (9) [back to overview]Incidence of Grade III/IV Acute Graft Versus Host Disease (GVHD)
NCT00358657 (9) [back to overview]Number of Patients With Infections
NCT00358657 (9) [back to overview]Graft Failure
NCT00358657 (9) [back to overview]Graft Rejection
NCT00358657 (9) [back to overview]Immune Reconstitution
NCT00358657 (9) [back to overview]Incidence of Chronic GVHD
NCT00358657 (9) [back to overview]Proportion of Patients Who Achieve Greater Than 5% Donor T-cell Chimerism
NCT00358657 (9) [back to overview]Number of Patients With Transplant Related Mortality
NCT00358657 (9) [back to overview]Incidence of Grade I/II Acute Graft Versus Host Disease (GVHD)
NCT00361140 (2) [back to overview]Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)
NCT00361140 (2) [back to overview]Non-relapse Mortality
NCT00381004 (3) [back to overview]Number of Participants Progression-free
NCT00381004 (3) [back to overview]Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.
NCT00381004 (3) [back to overview]Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.
NCT00381550 (2) [back to overview]Incidence of Grade 3 or 4 Drug-related Non-hematologic Toxicity as Assessed by NCI CTCAE v3.0
NCT00381550 (2) [back to overview]Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation
NCT00385788 (1) [back to overview]Transplant Related Mortality Rate
NCT00387959 (1) [back to overview]Survival at 1 Year After Transplantation
NCT00392782 (7) [back to overview]Incidence of Disease-free Survival
NCT00392782 (7) [back to overview]Incidence of Disease Relapse
NCT00392782 (7) [back to overview]Incidence of Chronic Graft-versus-host Disease (GVHD)
NCT00392782 (7) [back to overview]Overall Survival
NCT00392782 (7) [back to overview]Incidence of Graft Failure
NCT00392782 (7) [back to overview]Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)
NCT00392782 (7) [back to overview]Transplant-related Mortality
NCT00393029 (3) [back to overview]The Number of Participants With Adverse Events
NCT00393029 (3) [back to overview]In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants
NCT00393029 (3) [back to overview]Clinical Tumor Regression
NCT00397813 (5) [back to overview]Number of Patients With HCT Failure.
NCT00397813 (5) [back to overview]Number of Patients Who Engrafted
NCT00397813 (5) [back to overview]Number of Patients Who Had Infections
NCT00397813 (5) [back to overview]Number of Patients With Progression-free Survival
NCT00397813 (5) [back to overview]Number of Patients With Relapse/Progression
NCT00425802 (8) [back to overview]Time to Neutrophil Engraftment
NCT00425802 (8) [back to overview]Immune Reconstruction/CD4+ Count at 6 Months
NCT00425802 (8) [back to overview]Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days
NCT00425802 (8) [back to overview]Incidence of Chronic GVHD at 1 Year
NCT00425802 (8) [back to overview]Immune Reconstruction/CD4+ Count at 3 Months
NCT00425802 (8) [back to overview]Overall Survival at 1 Year
NCT00425802 (8) [back to overview]Immune Reconstruction/CD4+ Count at 1 Year
NCT00425802 (8) [back to overview]Time to Platelet Engraftment
NCT00427336 (1) [back to overview]Number of Patients With Engraftment Response
NCT00427557 (1) [back to overview]Number of Participants With Engraftment
NCT00429416 (5) [back to overview]Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)
NCT00429416 (5) [back to overview]Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality
NCT00429416 (5) [back to overview]Rate of Serious Infectious Complications
NCT00429416 (5) [back to overview]Rate of Engraftment of Non-Myeloablative Transplants
NCT00429416 (5) [back to overview]Number of Patients Who Achieve a CD4 Count > 200/Micro-liters
NCT00448019 (3) [back to overview]Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL
NCT00448019 (3) [back to overview]Progression Free Survival (PFS) Rate
NCT00448019 (3) [back to overview]Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)
NCT00448201 (4) [back to overview]Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant
NCT00448201 (4) [back to overview]Graft-vs-host Disease at 6 Months Post-transplant
NCT00448201 (4) [back to overview]Treatment-related Mortality
NCT00448201 (4) [back to overview]5-year Disease-free Survival
NCT00448357 (6) [back to overview]Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)
NCT00448357 (6) [back to overview]Incidence of DNA Chimerism in Patients Between One Month Post Transplant
NCT00448357 (6) [back to overview]Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant
NCT00448357 (6) [back to overview]Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen
NCT00448357 (6) [back to overview]Overall Survival
NCT00448357 (6) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs)
NCT00450983 (4) [back to overview]Risk for Mortality From Infection Before Day 180
NCT00450983 (4) [back to overview]Risk for Life-threatening Infections
NCT00450983 (4) [back to overview]Risk for Graft Failure
NCT00450983 (4) [back to overview]Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)
NCT00452374 (2) [back to overview]Maximum Tolerated Dose (MTD) Oxaliplatin
NCT00452374 (2) [back to overview]Number of Participants With a Complete Response or Partial Response
NCT00453388 (4) [back to overview]Incidence of Adverse Events
NCT00453388 (4) [back to overview]Incidence of Grades III-IV Acute GVHD
NCT00453388 (4) [back to overview]Number of Patients Who Engraft at Each Dose of TBI Used
NCT00453388 (4) [back to overview]Incidence of Transplant-related Mortality
NCT00462332 (2) [back to overview]Length of Survival
NCT00462332 (2) [back to overview]Number of Patients With Complete Response
NCT00469014 (1) [back to overview]Treatment Related Mortality
NCT00475020 (2) [back to overview]Efficacy of This Therapy 3 Years Post-transplant
NCT00475020 (2) [back to overview]Rate of Non-relapse Mortality at 100 Days Post-transplant
NCT00478244 (10) [back to overview]Number of Patients With Platelet Engraftment
NCT00478244 (10) [back to overview]Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)
NCT00478244 (10) [back to overview]Number of Patients With Transplant-Related Mortality
NCT00478244 (10) [back to overview]Number of Patients With >70% Donor Chimerism
NCT00478244 (10) [back to overview]Overall Survival
NCT00478244 (10) [back to overview]Number of Patients With Detectable Collagen Type VII
NCT00478244 (10) [back to overview]Number of Patients With Donor Derived Cells in Skin
NCT00478244 (10) [back to overview]Number of Patients With Neutrophil Engraftment
NCT00478244 (10) [back to overview]Number of Patients With Resistance to Blister Formation
NCT00478244 (10) [back to overview]Number of Patients With Acute Graft-Versus-Host Disease (GVHD)
NCT00480987 (1) [back to overview]Number of Participants With Objective Response
NCT00499889 (3) [back to overview]Participants' With mCR Response to Post Transplant DLI
NCT00499889 (3) [back to overview]Number of Participants in Complete Molecular Remission at 1 Year
NCT00499889 (3) [back to overview]Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy
NCT00502905 (1) [back to overview]Number of Participants With Successful Engraftment
NCT00505895 (2) [back to overview]Number of Participants With Successful Engraftment at Day 100
NCT00505895 (2) [back to overview]Acute Grade II-IV Graft Versus Host Disease (GVHD)
NCT00505921 (1) [back to overview]Participant Progression Free Survival at 2 Years
NCT00506129 (2) [back to overview]Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
NCT00506129 (2) [back to overview]Average Overall Survival (OS) Length
NCT00506857 (2) [back to overview]Maximum Tolerated Dose (MTD)
NCT00506857 (2) [back to overview]Number of Participants With Graft Versus Host Disease (GVHD)
NCT00509496 (2) [back to overview]Toxicity
NCT00509496 (2) [back to overview]Clinical Tumor Regression.
NCT00513604 (2) [back to overview]Toxicity
NCT00513604 (2) [back to overview]Clinical Response
NCT00513747 (5) [back to overview]Overall Survival in Low Risk Patients
NCT00513747 (5) [back to overview]Disease-Free Survival in High Risk Patients
NCT00513747 (5) [back to overview]Overall Survival (OS) for High Risk Patients
NCT00513747 (5) [back to overview]Time to First Treatment Survival in Low Risk Patients
NCT00513747 (5) [back to overview]Time to Second Treatment in High Risk Patients
NCT00525603 (1) [back to overview]Overall Participant Response
NCT00525876 (1) [back to overview]Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)
NCT00544115 (2) [back to overview]Neutrophil Engraftment - The Days Till ANC Recovery
NCT00544115 (2) [back to overview]Two-year Overall Survival
NCT00544466 (2) [back to overview]Overall Survival on Day 180 Days Post-transplant
NCT00544466 (2) [back to overview]Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.
NCT00547196 (2) [back to overview]Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
NCT00547196 (2) [back to overview]Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)
NCT00553098 (11) [back to overview]Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant
NCT00553098 (11) [back to overview]Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant
NCT00553098 (11) [back to overview]Disease Response by 1 Year Post Transplant
NCT00553098 (11) [back to overview]Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant
NCT00553098 (11) [back to overview]Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism
NCT00553098 (11) [back to overview]Overall Survival
NCT00553098 (11) [back to overview]Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD
NCT00553098 (11) [back to overview]Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD
NCT00553098 (11) [back to overview]Number of Patients Diagnosed With Chronic GVHD
NCT00553098 (11) [back to overview]Number of Patients Diagnosed With Acute GVHD
NCT00553098 (11) [back to overview]Immune Reconstitution by 1 Year Post Transplant
NCT00574496 (3) [back to overview]Progression-free Survival at 1 Year
NCT00574496 (3) [back to overview]Overall Survival
NCT00574496 (3) [back to overview]Disease Relapse or Progression as Measured by CT Scan or PET
NCT00577278 (3) [back to overview]Relapse/Progression Rate at Two Years
NCT00577278 (3) [back to overview]Progression-free Survival at Two Years
NCT00577278 (3) [back to overview]Overall Survival at Two Years
NCT00582933 (1) [back to overview]Death From GVHD
NCT00589316 (1) [back to overview]Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen
NCT00589563 (14) [back to overview]Time to Absolute Neutrophil Count Recovery (Engraftment)
NCT00589563 (14) [back to overview]Incidence of Disease Relapse/Progression at 2 Years Post HSCT
NCT00589563 (14) [back to overview]Event Free Survival at Two Years Post HSCT
NCT00589563 (14) [back to overview]Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
NCT00589563 (14) [back to overview]Cumulative Incidence of Chronic GVHD
NCT00589563 (14) [back to overview]Non-relapse Mortality at 100 Days Post HSCT
NCT00589563 (14) [back to overview]Overall Survival at Two Years Post HSCT
NCT00589563 (14) [back to overview]Non-relapse Mortality at Two Years Post HSCT
NCT00589563 (14) [back to overview]Occurrence of Thrombotic Microangiopathy
NCT00589563 (14) [back to overview]Severity of Chronic GVHD
NCT00589563 (14) [back to overview]Severity of Acute GVHD
NCT00589563 (14) [back to overview]Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
NCT00589563 (14) [back to overview]Time to Platelet Count Recovery (Engraftment)
NCT00589563 (14) [back to overview]Occurence of Sinusoidal Obstructive Syndrome (SOS)
NCT00602459 (6) [back to overview]Overall Response Rates in Patients With Del(11q22.3)
NCT00602459 (6) [back to overview]Overall Response Rate in Patients Without Del(11q22.3)
NCT00602459 (6) [back to overview]PFS Rate of Patients With Del(11q22.3)
NCT00602459 (6) [back to overview]Time-to-progression in Patients With Del(11q22.3)
NCT00602459 (6) [back to overview]Time-to-progression in Patients Without Del(11q22.3)
NCT00602459 (6) [back to overview]2-Year Progression Free Survival (PFS) Rate
NCT00603954 (11) [back to overview]Percentage of Participants With Chronic GVHD in the 2 Groups
NCT00603954 (11) [back to overview]Percentage of Relapse Rate in the 2 Groups
NCT00603954 (11) [back to overview]Percentage of 4-year Overall Survival in the 2 Groups
NCT00603954 (11) [back to overview]Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels
NCT00603954 (11) [back to overview]Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups
NCT00603954 (11) [back to overview]Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups.
NCT00603954 (11) [back to overview]Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism
NCT00603954 (11) [back to overview]Percentage of 4-year Progression Free Survival in the 2 Groups
NCT00603954 (11) [back to overview]Percentage of 5-year Overall Survival in the 2 Groups
NCT00603954 (11) [back to overview]Percentage of 5-year Progression Free Survival in the 2 Groups
NCT00603954 (11) [back to overview]Percentage of Non Relapse Mortality in the 2 Groups
NCT00608517 (7) [back to overview]Number of Participants With Acute Graft-versus-host Disease (GVHD)
NCT00608517 (7) [back to overview]Overall Survival
NCT00608517 (7) [back to overview]Number of Subjects With All-cause Mortality
NCT00608517 (7) [back to overview]Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells
NCT00608517 (7) [back to overview]Number of Participants With Chronic Graft Versus Host Disease (GVHD)
NCT00608517 (7) [back to overview]Number of Participants With 100-day Non-relapse Mortality
NCT00608517 (7) [back to overview]Number of Participants Who Relapsed at 1 Year
NCT00610311 (2) [back to overview]Number of Participants With Adverse Events
NCT00610311 (2) [back to overview]Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)
NCT00612222 (2) [back to overview]Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)
NCT00612222 (2) [back to overview]Number of Participants With Adverse Events
NCT00618540 (8) [back to overview]Neutrophil Engraftment
NCT00618540 (8) [back to overview]Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)
NCT00618540 (8) [back to overview]Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)
NCT00618540 (8) [back to overview]Incidence of Chronic GVHD
NCT00618540 (8) [back to overview]Overall Survival
NCT00618540 (8) [back to overview]Transplantation-related Death
NCT00618540 (8) [back to overview]Disease-free Survival at 12 Months Post Transplantation
NCT00618540 (8) [back to overview]Platelet Engraftment
NCT00619645 (2) [back to overview]Number of Patients With Day 100 Transplant-related Mortality
NCT00619645 (2) [back to overview]Number of Patients Alive 24 Months Post Day 100 Transplant
NCT00622895 (10) [back to overview]Treatment-related Mortality
NCT00622895 (10) [back to overview]Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36)
NCT00622895 (10) [back to overview]Incidence and Severity of Graft-versus-host Disease (GVHD)
NCT00622895 (10) [back to overview]Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)
NCT00622895 (10) [back to overview]Skin Score
NCT00622895 (10) [back to overview]Event-free Survival (EFS)
NCT00622895 (10) [back to overview]EFS
NCT00622895 (10) [back to overview]Incidence of Graft Rejection
NCT00622895 (10) [back to overview]Overall Survival
NCT00622895 (10) [back to overview]The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections
NCT00625729 (6) [back to overview]Number of Patients Exhibiting Natural Killer Cell Expansion
NCT00625729 (6) [back to overview]Number of Patients With Interleukin-15 Production and NK Cell Expansion
NCT00625729 (6) [back to overview]Number of Patients With Adequate Natural Killer Cells Infused
NCT00625729 (6) [back to overview]Number of Patients Whose Disease Progressed After Treatment
NCT00625729 (6) [back to overview]Number of Patients With Overall Survival
NCT00625729 (6) [back to overview]Number of Patients With Overall Response
NCT00652899 (4) [back to overview]Median Number of Days to Progression
NCT00652899 (4) [back to overview]Number of Patients Per Disease Response
NCT00652899 (4) [back to overview]Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
NCT00652899 (4) [back to overview]Median Overall Survival Number of Days Patients Alive After Treatment
NCT00670748 (3) [back to overview]Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00670748 (3) [back to overview]Number of Participants With Serious and Non-Serious Adverse Events
NCT00670748 (3) [back to overview]Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells
NCT00691015 (8) [back to overview]Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )
NCT00691015 (8) [back to overview]Overall Survival.
NCT00691015 (8) [back to overview]Karnofsky Performance Status Performance Status
NCT00691015 (8) [back to overview]Incidence of Acute Graft-versus-host Disease (GVHD)
NCT00691015 (8) [back to overview]Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)
NCT00691015 (8) [back to overview]Incidence of Chronic GVHD.
NCT00691015 (8) [back to overview]Severity of Acute Graft-versus-host Disease (GVHD)
NCT00691015 (8) [back to overview]Safety, as Defined by Serious Adverse Events and Adverse Events Related to Study Treatment.
NCT00704938 (2) [back to overview]Clinical Response (Complete Response + Partial Response)
NCT00704938 (2) [back to overview]Number of Participants With Adverse Events
NCT00719849 (16) [back to overview]Chimerism
NCT00719849 (16) [back to overview]Incidence of Relapse at 2 Years
NCT00719849 (16) [back to overview]Incidence of Non-relapse Mortality at 6 Months
NCT00719849 (16) [back to overview]Incidence of Neutrophil Engraftment at Day 42
NCT00719849 (16) [back to overview]Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100
NCT00719849 (16) [back to overview]Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100
NCT00719849 (16) [back to overview]Probability of Survival at 1 Year
NCT00719849 (16) [back to overview]Incidence of Clinically Significant Infections at 6 Months
NCT00719849 (16) [back to overview]Incidence of Clinically Significant Infections at 2 Years
NCT00719849 (16) [back to overview]Incidence of Clinically Significant Infections at 1 Year
NCT00719849 (16) [back to overview]Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year
NCT00719849 (16) [back to overview]Incidence of Relapse at 1 Year
NCT00719849 (16) [back to overview]Incidence of Platelet Engraftment at 6 Months
NCT00719849 (16) [back to overview]Probability of Survival at 2 Years
NCT00719849 (16) [back to overview]Probability of Progression-free Survival at 2 Years
NCT00719849 (16) [back to overview]Probability of Progression-free Survival at 1 Year
NCT00723099 (9) [back to overview]Number of Participants With Graft Failure/Rejection
NCT00723099 (9) [back to overview]Time to Platelet Engraftment of > 20,000 Cells Per mm3
NCT00723099 (9) [back to overview]Median Time to ANC > 500
NCT00723099 (9) [back to overview]Overall Survival
NCT00723099 (9) [back to overview]Percent of Patients With Acute GVHD Grades III-IV
NCT00723099 (9) [back to overview]Percent of Patients With Chronic GVHD
NCT00723099 (9) [back to overview]Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
NCT00723099 (9) [back to overview]Percent of Patients With Non-relapse Mortality
NCT00723099 (9) [back to overview]Percent of Patients With Non-relapse Mortality
NCT00727415 (6) [back to overview]Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).
NCT00727415 (6) [back to overview]Maximum Tolerated Dose of Lenalidomide (Phase I)
NCT00727415 (6) [back to overview]Number of Patients Reaching Disease-free Survival (DSF) Overall
NCT00727415 (6) [back to overview]Number of Patients With Severe Infections
NCT00727415 (6) [back to overview]Overall Complete Response (CR) Rate (Phase II)
NCT00727415 (6) [back to overview]Toxicity as Assessed by NCI CTCAE v3.0
NCT00775931 (4) [back to overview]Incidence of Grade II - IV Acute Graft-versus-host Disease
NCT00775931 (4) [back to overview]Transplant Related Toxicity
NCT00775931 (4) [back to overview]Number of Patients Who Achieved Donor Cell Engraftment
NCT00775931 (4) [back to overview]Transplant Related Mortality at 100 Days
NCT00782379 (11) [back to overview]Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation
NCT00782379 (11) [back to overview]Overall Survival at Day 100
NCT00782379 (11) [back to overview]Overall Survival at 12 Months
NCT00782379 (11) [back to overview]Disease Free Survival at Day 100
NCT00782379 (11) [back to overview]Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)
NCT00782379 (11) [back to overview]Incidence of Graft Rejection for Patients at Day 100
NCT00782379 (11) [back to overview]Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)
NCT00782379 (11) [back to overview]Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)
NCT00782379 (11) [back to overview]Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation
NCT00782379 (11) [back to overview]Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation
NCT00782379 (11) [back to overview]Disease Free Survival at 12 Months
NCT00787761 (8) [back to overview]Non-relapse Mortality (NRM) at Day 180 Post-transplantation
NCT00787761 (8) [back to overview]Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)
NCT00787761 (8) [back to overview]Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease
NCT00787761 (8) [back to overview]Overall Survival (OS) at 24 Months
NCT00787761 (8) [back to overview]T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)
NCT00787761 (8) [back to overview]T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)
NCT00787761 (8) [back to overview]Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation
NCT00787761 (8) [back to overview]Disease-free Survival (DFS) at 24 Months
NCT00789776 (7) [back to overview]Number of Participants Who Experienced Chronic Extensive GVHD
NCT00789776 (7) [back to overview]Number of Participants With Relapsed Disease
NCT00789776 (7) [back to overview]Number of Non-relapse Participant Mortalities
NCT00789776 (7) [back to overview]Number of Subjects Surviving Post-transplant.
NCT00789776 (7) [back to overview]Number of Participants With Grades III-IV Acute GVHD
NCT00789776 (7) [back to overview]Number of Participants With Dose Limiting Toxicities
NCT00789776 (7) [back to overview]Number of Participants Who Experienced Graft Failure
NCT00793572 (6) [back to overview]Number of Patients Surviving Progression-free
NCT00793572 (6) [back to overview]Number of Patients Surviving Overall
NCT00793572 (6) [back to overview]Number of Patients With Non-relapse Mortality
NCT00793572 (6) [back to overview]Number of Patients With Toxicities Related to Bortezomib Maintenance Therapy
NCT00793572 (6) [back to overview]Number of Patients With Grade II-IV Acute GVHD
NCT00793572 (6) [back to overview]Number of Patients With Chronic GVHD
NCT00794820 (3) [back to overview]Overall Survival (OS) Rate
NCT00794820 (3) [back to overview]Remission Duration/Time to Progression (TTP)
NCT00794820 (3) [back to overview]Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months
NCT00796068 (12) [back to overview]Number of Participants Surviving up to 2 Years Without Disease Progression
NCT00796068 (12) [back to overview]Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100
NCT00796068 (12) [back to overview]Number of Participants With Graft Failure/Rejection
NCT00796068 (12) [back to overview]Number of Participants With Secondary Graft Failure
NCT00796068 (12) [back to overview]The Number of Participants Alive at Two-years Follow up.
NCT00796068 (12) [back to overview]Number of Patients With Non-relapse Mortality (NRM)
NCT00796068 (12) [back to overview]Duration (Days) Until Participants Obtained Platelet Engraftment
NCT00796068 (12) [back to overview]Incidence of Acute or Chronic Graft-versus-host Disease (GVHD)
NCT00796068 (12) [back to overview]Incidence of Clinically Significant Infections
NCT00796068 (12) [back to overview]Incidence of Relapse or Disease Progression
NCT00796068 (12) [back to overview]Non-relapse Mortality
NCT00796068 (12) [back to overview]Number of Participants Surviving by 1 Year
NCT00800839 (6) [back to overview]2-year Overall Survival
NCT00800839 (6) [back to overview]Day-100 Treatment-Related Mortality
NCT00800839 (6) [back to overview]2-year Progression-Free Survival
NCT00800839 (6) [back to overview]Cumulative Incidence of Grade II to IV Acute GVHD
NCT00800839 (6) [back to overview]Cumulative Incidence of Grade III to IV Acute GVHD
NCT00800839 (6) [back to overview]Rate of Engraftment
NCT00813124 (1) [back to overview]Number of Participants With Molecular Response
NCT00818961 (11) [back to overview]Overall Survival at 1 Year
NCT00818961 (11) [back to overview]Non-relapse Mortality at 1 Year Post-transplant
NCT00818961 (11) [back to overview]Neutrophil Recovery
NCT00818961 (11) [back to overview]Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism
NCT00818961 (11) [back to overview]Platelet Engraftment
NCT00818961 (11) [back to overview]Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant
NCT00818961 (11) [back to overview]Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant
NCT00818961 (11) [back to overview]Non-relapse Mortality at Day 100
NCT00818961 (11) [back to overview]Complete Donor Chimerism
NCT00818961 (11) [back to overview]Survival at Day 100
NCT00818961 (11) [back to overview]Number of Patients Experiencing Chronic Graft Versus Host Disease
NCT00822770 (3) [back to overview]Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30
NCT00822770 (3) [back to overview]Number of Participants Alive With no Disease Progression at Time of Allo Transplant
NCT00822770 (3) [back to overview]Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor
NCT00827099 (2) [back to overview]Number of Patients That Engrafted Blood Counts by 30 Days After Transplant
NCT00827099 (2) [back to overview]Number of Participants With 100 Day Transplant-related Mortality (TRM)
NCT00856388 (8) [back to overview]Rate of Complete Donor Chimerism - Blood
NCT00856388 (8) [back to overview]Median Time to Platelet Engraftment
NCT00856388 (8) [back to overview]Rate of Complete Donor Chimerism - Blood
NCT00856388 (8) [back to overview]Median Time to ANC Engraftment
NCT00856388 (8) [back to overview]Day 100 TRM
NCT00856388 (8) [back to overview]Acute GVHD Grade III-IV
NCT00856388 (8) [back to overview]1 yr Extenstive Chronic GVHD
NCT00856388 (8) [back to overview]3 yr Overall Survival
NCT00860574 (8) [back to overview]Incidence of Chronic GVHD
NCT00860574 (8) [back to overview]Incidence of Grades II-IV Acute GVHD
NCT00860574 (8) [back to overview]Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood
NCT00860574 (8) [back to overview]Non Relapse Mortality (NRM) Incidence
NCT00860574 (8) [back to overview]Relapse-free Survival
NCT00860574 (8) [back to overview]Relapse Incidence
NCT00860574 (8) [back to overview]Overall Survival (OS)
NCT00860574 (8) [back to overview]Non Relapse Mortality Incidence
NCT00871689 (8) [back to overview]Number of Patients With Complete Remission of Disease
NCT00871689 (8) [back to overview]Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease
NCT00871689 (8) [back to overview]Number of Patients With Acute Graft-Versus-Host (GVHD) Disease
NCT00871689 (8) [back to overview]Number of Patients With Neutrophil Engraftment
NCT00871689 (8) [back to overview]Number of Patients With Successful Natural Killer Expansion
NCT00871689 (8) [back to overview]Number of Patients With Transplant-Related Death (TRD)
NCT00871689 (8) [back to overview]Median Overall Survival
NCT00871689 (8) [back to overview]Incidence of Primary Graft Failure
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to Progression According to the IRC Central Review
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review
NCT00875667 (47) [back to overview]Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review
NCT00875667 (47) [back to overview]Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis
NCT00875667 (47) [back to overview]Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review
NCT00875667 (47) [back to overview]Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Constipation
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
NCT00875667 (47) [back to overview]Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
NCT00875667 (47) [back to overview]Number of Participants With Treatment Emergent Adverse Events
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit
NCT00875667 (47) [back to overview]Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit
NCT00899431 (1) [back to overview]Percentage of Participants With GVHD (Graft Versus Host Disease)
NCT00914940 (4) [back to overview]Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant
NCT00914940 (4) [back to overview]Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant
NCT00914940 (4) [back to overview]Transplant-related Mortality by Day 100
NCT00914940 (4) [back to overview]Number of Participants With Chronic GVHD
NCT00918723 (4) [back to overview]To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat
NCT00918723 (4) [back to overview]Percentage of Patients With Progression-free Survival at 2 Years
NCT00918723 (4) [back to overview]Overall Survival
NCT00918723 (4) [back to overview]Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)
NCT00919503 (10) [back to overview]Number of Participants With Infections
NCT00919503 (10) [back to overview]Preliminary Efficacy
NCT00919503 (10) [back to overview]Number of Patients With of Chronic Graft-versus-host Disease
NCT00919503 (10) [back to overview]Number of Patients With Grade II-IV Acute Graft-versus-host Disease
NCT00919503 (10) [back to overview]Non-relapse Mortality
NCT00919503 (10) [back to overview]Immune Reconstitution Following Hematopoietic Cell Transplantation
NCT00919503 (10) [back to overview]Disease Response at One Year Following Hematopoietic Cell Transplantation
NCT00919503 (10) [back to overview]Donor Chimerism CD3 at 100 Days Post Transplant
NCT00919503 (10) [back to overview]Overall Survival
NCT00919503 (10) [back to overview]Donor Chimerism CD33 at Day 100 Post Transplant
NCT00923364 (7) [back to overview]Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)
NCT00923364 (7) [back to overview]Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
NCT00923364 (7) [back to overview]Days to Neutrophil Engraftment
NCT00923364 (7) [back to overview]Days to Platelet Engraftment
NCT00923364 (7) [back to overview]Number of Participants With Disease Free Survival
NCT00923364 (7) [back to overview]Number of Participants With Serious and Non-serious Adverse Events
NCT00923364 (7) [back to overview]Overall Survival
NCT00924326 (2) [back to overview]Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).
NCT00924326 (2) [back to overview]Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma
NCT00943800 (3) [back to overview]Percentage of Participants With Neutrophil Engraftment
NCT00943800 (3) [back to overview]Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years
NCT00943800 (3) [back to overview]Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)
NCT00963872 (20) [back to overview]Chronic Graft-Versus-Host Disease
NCT00963872 (20) [back to overview]Disease Progression
NCT00963872 (20) [back to overview]Disease Progression
NCT00963872 (20) [back to overview]Donor Chimerism
NCT00963872 (20) [back to overview]Donor Chimerism
NCT00963872 (20) [back to overview]Donor Chimerism in Blood
NCT00963872 (20) [back to overview]Incidence of Grades II-IV Graft-vs-host Disease
NCT00963872 (20) [back to overview]Incidence of Grades III-IV Graft-vs-host Disease
NCT00963872 (20) [back to overview]Neutrophil Engraftment
NCT00963872 (20) [back to overview]Non-Relapse Mortality
NCT00963872 (20) [back to overview]Non-relapse Mortality
NCT00963872 (20) [back to overview]Number of Patients With the Complement 3a (C3a) Unit Predominating
NCT00963872 (20) [back to overview]Overall Survival
NCT00963872 (20) [back to overview]Overall Survival at Day 720
NCT00963872 (20) [back to overview]Platelet Recovery
NCT00963872 (20) [back to overview]Donor Chimerism
NCT00963872 (20) [back to overview]Relapse of Disease
NCT00963872 (20) [back to overview]Relapse of Disease
NCT00963872 (20) [back to overview]Donor Chimerism in Blood
NCT00963872 (20) [back to overview]Bone Marrow Chimerism
NCT01008462 (7) [back to overview]Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
NCT01008462 (7) [back to overview]Event-Free Survival (EFS)
NCT01008462 (7) [back to overview]Number of Patients Who Engrafted
NCT01008462 (7) [back to overview]Number of Patients Who Had Infections
NCT01008462 (7) [back to overview]Number of Patients With Relapsed/Progressive Disease
NCT01008462 (7) [back to overview]Overall Survival
NCT01008462 (7) [back to overview]Non-relapse Mortality (NRM)
NCT01010217 (6) [back to overview]cGVHD
NCT01010217 (6) [back to overview]Disease Free Survival
NCT01010217 (6) [back to overview]Number of Participants With Non-relapse Mortality (NRM)
NCT01010217 (6) [back to overview]Number of Participants With Non Related Mortality (NRM)
NCT01010217 (6) [back to overview]Grade III-IV aGVHD
NCT01010217 (6) [back to overview]Engraftments
NCT01019317 (1) [back to overview]Participants With a Complete Response
NCT01027000 (1) [back to overview]2-year Progression-free Survival in Early Disease Participants
NCT01028716 (12) [back to overview]Number of Platelet Transfusions
NCT01028716 (12) [back to overview]Non-relapse Mortality at 1 Year
NCT01028716 (12) [back to overview]Incidence of Primary Graft Failure
NCT01028716 (12) [back to overview]Incidence of Grades III/IV Acute Graft Versus Host Disease
NCT01028716 (12) [back to overview]Disease-free Survival
NCT01028716 (12) [back to overview]Relapse of Malignancy After Transplantation
NCT01028716 (12) [back to overview]Percentage of Participants With Chronic Graft Versus Host Disease
NCT01028716 (12) [back to overview]Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System
NCT01028716 (12) [back to overview]Time to Neutrophil Recovery
NCT01028716 (12) [back to overview]Number of Red Blood Cell Transfusions
NCT01028716 (12) [back to overview]Time to Platelet Recovery
NCT01028716 (12) [back to overview]Point Estimate of Overall Survival at 3 Years
NCT01044745 (4) [back to overview]Transplant-related Mortality (TRM)
NCT01044745 (4) [back to overview]Number of Participants With Grades II-IV Acute GVHD
NCT01044745 (4) [back to overview]Event-free Survival
NCT01044745 (4) [back to overview]Overall Survival
NCT01050764 (6) [back to overview]To Measure the Incidence and Severity of Acute and Chronic GvHD
NCT01050764 (6) [back to overview]Overall Survival (OS), 1 Year
NCT01050764 (6) [back to overview]Median Overall Survival (OS)
NCT01050764 (6) [back to overview]Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells
NCT01050764 (6) [back to overview]Acute Graft-versus-Host-Disease (aGvHD)
NCT01050764 (6) [back to overview]Serious Infections
NCT01082939 (1) [back to overview]Number of Participants With an Overall Response
NCT01096992 (2) [back to overview]Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
NCT01096992 (2) [back to overview]Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)
NCT01131169 (2) [back to overview]Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)
NCT01131169 (2) [back to overview]Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years
NCT01145209 (6) [back to overview]Progression Free Survival Rate 2 Years After Initiation of Induction Therapy
NCT01145209 (6) [back to overview]Number of Grade 3 and 4 Treatment Related Adverse Events
NCT01145209 (6) [back to overview]Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity
NCT01145209 (6) [back to overview]Participants With Minimal Residual Disease (MRD) Negativity
NCT01145209 (6) [back to overview]Participants With Complete Response Rates Following Induction Chemoimmunotherapy.
NCT01145209 (6) [back to overview]Median Relationship of CD20 Expression With MRD Negativity Rate
NCT01168219 (3) [back to overview]100-day Mortality
NCT01168219 (3) [back to overview]Overall Survival (OS)
NCT01168219 (3) [back to overview]Progression-free Survival
NCT01203020 (9) [back to overview]Relapse Rate (RR) Following Transplantation at 2-year.
NCT01203020 (9) [back to overview]Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.
NCT01203020 (9) [back to overview]Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.
NCT01203020 (9) [back to overview]Relapse Rate (RR) Following Transplantation at 1-year.
NCT01203020 (9) [back to overview]Percentage of 1-year Progression Free Survival (PFS)
NCT01203020 (9) [back to overview]Percentage of 2-year Progression Free Survival (PFS)
NCT01203020 (9) [back to overview]Percentage of 2 Year Overall Survival (OS)
NCT01203020 (9) [back to overview]Rates of Acute and Chronic Graft Versus Host Disease (GVHD).
NCT01203020 (9) [back to overview]Percentage of 1 Year Overall Survival (OS)
NCT01231412 (6) [back to overview]Number of Patients With Grades III-IV Acute GVHD
NCT01231412 (6) [back to overview]Number of of Participants Surviving Overall
NCT01231412 (6) [back to overview]Number of Patients With Chronic Extensive GVHD
NCT01231412 (6) [back to overview]Number of Non-Relapse Mortalities
NCT01231412 (6) [back to overview]Number of Participants With Relapse/Progression
NCT01231412 (6) [back to overview]Number of Patients With Grades II-IV Acute GVHD
NCT01251575 (3) [back to overview]Number of Non-Relapse Mortalities
NCT01251575 (3) [back to overview]Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)
NCT01251575 (3) [back to overview]Number of Patients With Grade III-IV Acute GVHD
NCT01256398 (6) [back to overview]Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
NCT01256398 (6) [back to overview]Disease Free Survival (DFS)
NCT01256398 (6) [back to overview]Response
NCT01256398 (6) [back to overview]Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
NCT01256398 (6) [back to overview]Overall Survival (OS)
NCT01256398 (6) [back to overview]Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.
NCT01300572 (9) [back to overview]Achievement of Remission
NCT01300572 (9) [back to overview]Rates of Engraftment
NCT01300572 (9) [back to overview]Rates of Donor Chimerism
NCT01300572 (9) [back to overview]The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.
NCT01300572 (9) [back to overview]Disease-free Survival
NCT01300572 (9) [back to overview]Rates of Non-relapse Mortality
NCT01300572 (9) [back to overview]Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor
NCT01300572 (9) [back to overview]Duration of Remission
NCT01300572 (9) [back to overview]Overall Survival
NCT01310179 (2) [back to overview]Treatment Outcome and Percent Change in Tumor Volume
NCT01310179 (2) [back to overview]Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment
NCT01339910 (10) [back to overview]Number of Participants With Primary Graft Failure
NCT01339910 (10) [back to overview]Percentage of Participants With Chronic GVHD
NCT01339910 (10) [back to overview]Percentage of Participants With Disease Relapse
NCT01339910 (10) [back to overview]Percentage of Participants With Relapse-Free Survival (RFS)
NCT01339910 (10) [back to overview]Number of Participants With Donor Cell Engraftment
NCT01339910 (10) [back to overview]Number of Participants With Secondary Graft Failure
NCT01339910 (10) [back to overview]Percentage of Participants With Treatment-related Mortality
NCT01339910 (10) [back to overview]Percentage of Participants With Acute Graft Versus Host Disease (GVHD)
NCT01339910 (10) [back to overview]Percentage of Participants With Neutrophil and Platelet Engraftment
NCT01339910 (10) [back to overview]Percentage of Participants With Overall Survival (OS)
NCT01366612 (1) [back to overview]To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment
NCT01390402 (1) [back to overview]Number of Participants With Molecular Complete Remission at 3 Month Post Transplant
NCT01410344 (7) [back to overview]Chimerism
NCT01410344 (7) [back to overview]Percentage of Participants With Overall Survival
NCT01410344 (7) [back to overview]Percentage of Participants With Non-Relapse Mortality
NCT01410344 (7) [back to overview]Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD)
NCT01410344 (7) [back to overview]Percentage of Participants With Relapse/Progression
NCT01410344 (7) [back to overview]Percentage of Participants Recovering Hematologic Function
NCT01410344 (7) [back to overview]Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD)
NCT01427881 (9) [back to overview]Grades II-IV and III-IV Acute GVHD
NCT01427881 (9) [back to overview]Persistent or Recurrent Malignancy After HCT
NCT01427881 (9) [back to overview]Overall Survival
NCT01427881 (9) [back to overview]Chronic GVHD Requiring Systemic Immunosuppressive Treatment
NCT01427881 (9) [back to overview]Hematologic Recovery
NCT01427881 (9) [back to overview]Disease-free Survival
NCT01427881 (9) [back to overview]Donor Engraftment
NCT01427881 (9) [back to overview]Graft Failure
NCT01427881 (9) [back to overview]Non-relapse Mortality
NCT01434472 (7) [back to overview]Overall Survival
NCT01434472 (7) [back to overview]Treatment-related Mortality
NCT01434472 (7) [back to overview]Progression-free Survival
NCT01434472 (7) [back to overview]Absolute Neutrophil Count (ANC) Engraftment
NCT01434472 (7) [back to overview]Hematopoietic Toxicity
NCT01434472 (7) [back to overview]Response Rates
NCT01434472 (7) [back to overview]Platelet Engraftment
NCT01453101 (3) [back to overview]Overall Response Rate
NCT01453101 (3) [back to overview]Progression Free Survival
NCT01453101 (3) [back to overview]Overall Survival (OS)
NCT01471444 (4) [back to overview]Number of Participants With Non Relapse Mortality at 100 Day Post Transplant
NCT01471444 (4) [back to overview]Progression-Free Survival (PFS)
NCT01471444 (4) [back to overview]Overall Survival (OS) Post Transplant at 1, 3 and 5 Years
NCT01471444 (4) [back to overview]Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant.
NCT01490723 (2) [back to overview]Treatment-Related Mortality (TRM)
NCT01490723 (2) [back to overview]Overall Survival (OS)
NCT01499147 (4) [back to overview]Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
NCT01499147 (4) [back to overview]Number of Participants With Engraftment.
NCT01499147 (4) [back to overview]Participants With 100 Day Transplant-related Mortality.
NCT01499147 (4) [back to overview]Time to ANC and Platelet Engraftment
NCT01518153 (2) [back to overview]Overall Survival (OS)
NCT01518153 (2) [back to overview]Success Rate
NCT01527045 (8) [back to overview]Number of Patients With Recurrent or Progressive Malignancy
NCT01527045 (8) [back to overview]Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant
NCT01527045 (8) [back to overview]Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)
NCT01527045 (8) [back to overview]Number of Donors Discontinuing Atorvastatin Due to Toxicity
NCT01527045 (8) [back to overview]Number of Non-relapse Mortalities
NCT01527045 (8) [back to overview]Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy
NCT01527045 (8) [back to overview]Number of Patients Surviving Overall
NCT01527045 (8) [back to overview]Number of Patients With Chronic Extensive GVHD
NCT01529827 (4) [back to overview]Transplant Related Mortality (TRM)
NCT01529827 (4) [back to overview]Clinical Response
NCT01529827 (4) [back to overview]Median Time to Neutrophil Engraftment
NCT01529827 (4) [back to overview]Progression Free Survival (PFS) at One Year
NCT01570348 (11) [back to overview]Disease Activity
NCT01570348 (11) [back to overview]Incidence of Graft Rejection
NCT01570348 (11) [back to overview]Overall Survival
NCT01570348 (11) [back to overview]Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire
NCT01570348 (11) [back to overview]Regimen-related Toxicity Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4
NCT01570348 (11) [back to overview]Treatment-related Mortality (TRM)
NCT01570348 (11) [back to overview]Incidence of Disease-modifying Drugs for CD Initiated Post-transplant
NCT01570348 (11) [back to overview]Incidence and Severity of GVHD
NCT01570348 (11) [back to overview]EFS
NCT01570348 (11) [back to overview]Development of Infectious Complications
NCT01570348 (11) [back to overview]Event-free Survival (EFS)
NCT01572662 (3) [back to overview]Non-Relapse Mortality Rate (NRM)
NCT01572662 (3) [back to overview]Overall Survival
NCT01572662 (3) [back to overview]Overall Survival
NCT01640301 (11) [back to overview]Treatment-related Toxicity Rate (Arm II)
NCT01640301 (11) [back to overview]Treatment-related Toxicity Rate (Arm I)
NCT01640301 (11) [back to overview]Maintenance of T Cell Receptor (TCR) Expression of Transduced T Cells (Arm I) i.e. Persistence
NCT01640301 (11) [back to overview]Maintenance of Function of Transduced T Cells (Arm I)
NCT01640301 (11) [back to overview]Incidence of Relapse After T Cell Therapy (Arm II)
NCT01640301 (11) [back to overview]Disease-free Survival After T Cell Therapy
NCT01640301 (11) [back to overview]Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)
NCT01640301 (11) [back to overview]Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)
NCT01640301 (11) [back to overview]Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)
NCT01640301 (11) [back to overview]Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)
NCT01640301 (11) [back to overview]Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)
NCT01690520 (6) [back to overview]Overall Survival
NCT01690520 (6) [back to overview]Proportion of Participants With Chronic Graft Versus Host Disease
NCT01690520 (6) [back to overview]Time to Platelet Engraftment (20k)
NCT01690520 (6) [back to overview]Time to Neutrophil Engraftment
NCT01690520 (6) [back to overview]Proportion of Patients With Severe Acute Graft Versus Host Disease
NCT01690520 (6) [back to overview]Non-relapse Mortality
NCT01707004 (8) [back to overview]Overall Survival (OS)
NCT01707004 (8) [back to overview]Number of Participants With Primary Graft Failure
NCT01707004 (8) [back to overview]Number of Participants With Complete Remission After Transplantation
NCT01707004 (8) [back to overview]Cumulative Incidence of Grade III-IV Acute GVHD
NCT01707004 (8) [back to overview]Cumulative Incidence of Chronic GVHD According to BMTCTN
NCT01707004 (8) [back to overview]Time to Neutrophil Recovery
NCT01707004 (8) [back to overview]Progression Free Survival
NCT01707004 (8) [back to overview]Percentage of Participants With Platelet Recovery by Day 30
NCT01807182 (3) [back to overview]Count of Participants Who Experienced Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01807182 (3) [back to overview]A Count of Participants With Biomarker Expression Above Threshold
NCT01807182 (3) [back to overview]Number of Participants Who Experienced in Vivo Persistence of Adoptively Transferred T Cells Following TIL Infusion
NCT01823198 (3) [back to overview]Number of Participants Who Experienced Dose-limiting Toxicities (DLT)
NCT01823198 (3) [back to overview]Overall Survival
NCT01823198 (3) [back to overview]Number of Participants With Grade 3 Toxicities
NCT01824693 (4) [back to overview]Percent Probability of Event-free Survival (EFS)
NCT01824693 (4) [back to overview]Percent Probability of 18 Months-relapse Event Between Arms
NCT01824693 (4) [back to overview]Percentage of Participants Who Experience Primary Graft Failure Event Between Arms
NCT01824693 (4) [back to overview]Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100
NCT01861002 (1) [back to overview]Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
NCT01875237 (8) [back to overview]To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD
NCT01875237 (8) [back to overview]To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.
NCT01875237 (8) [back to overview]To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism
NCT01875237 (8) [back to overview]To Assess the Proportions of GvHD Response Post-administration of AP1903.
NCT01875237 (8) [back to overview]Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.
NCT01875237 (8) [back to overview]To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.
NCT01875237 (8) [back to overview]To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.
NCT01875237 (8) [back to overview]To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
NCT01877837 (2) [back to overview]Number of Participants With Graft Failure
NCT01877837 (2) [back to overview]Overall Survival
NCT01894477 (2) [back to overview]Number of Participants That Did Not Progress Within 6 Months
NCT01894477 (2) [back to overview]Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT01898793 (8) [back to overview]Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)
NCT01898793 (8) [back to overview]Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)
NCT01898793 (8) [back to overview]Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)
NCT01898793 (8) [back to overview]Overall Survival (OS) (Phase I, Phase II, and Pediatric)
NCT01898793 (8) [back to overview]Time to Progression (Phase I, Phase II, and Pediatric)
NCT01898793 (8) [back to overview]Safety of CIML NK Cells as Measured by the Number of Participants With Treatment Related Adverse Events (Pediatric Cohort)
NCT01898793 (8) [back to overview]Toxicity as Measured by the Number of Participants With Treatment Related Adverse Events (Phase I and Phase II)
NCT01898793 (8) [back to overview]Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)
NCT01993719 (13) [back to overview]Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
NCT01993719 (13) [back to overview]Number of Participants With Treatment-related Grade 3-5 Adverse Events in Arm 1N and Arm 1P
NCT01993719 (13) [back to overview]Overall Response Rate (ORR)
NCT01993719 (13) [back to overview]Overall Response Rate (ORR)
NCT01993719 (13) [back to overview]Overall Response Rate (ORR)
NCT01993719 (13) [back to overview]Progression-free Survival (PFS)
NCT01993719 (13) [back to overview]Progression-free Survival (PFS)
NCT01993719 (13) [back to overview]Progression-free Survival (PFS)
NCT01993719 (13) [back to overview]Overall Survival
NCT01993719 (13) [back to overview]Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01993719 (13) [back to overview]Number of Treatment-related Adverse Events for Participants Who Received Pembrolizumab
NCT01993719 (13) [back to overview]Overall Progression Free Survival (PFS)
NCT01993719 (13) [back to overview]Overall Survival
NCT02048813 (2) [back to overview]Progression-free Survival (PFS) Rate at 3 Years
NCT02048813 (2) [back to overview]Overall Survival (OS) Rate at 3 Years
NCT02248597 (5) [back to overview]12 Month Disease Free Survival Probability
NCT02248597 (5) [back to overview]Overall Survival
NCT02248597 (5) [back to overview]Progression Free Survival
NCT02248597 (5) [back to overview]Rate of Acute GvHD
NCT02248597 (5) [back to overview]Relapse-free Mortality
NCT02259348 (9) [back to overview]Incidence and Severity of Chronic GvHD
NCT02259348 (9) [back to overview]Event-free Survival (EFS)
NCT02259348 (9) [back to overview]Incidence of Malignant Relapse
NCT02259348 (9) [back to overview]Mean of Days to Absolute Neutrophil Count (ANC) Engraftment
NCT02259348 (9) [back to overview]Median Days to Absolute Neutrophil Count (ANC) Engraftment
NCT02259348 (9) [back to overview]Overall Survival (OS)
NCT02259348 (9) [back to overview]Percentage of Participants Engrafted by Day 42 Post-transplant
NCT02259348 (9) [back to overview]Rate of Transplant-related Mortality (TRM)
NCT02259348 (9) [back to overview]Incidence and Severity of Acute GvHD
NCT02626338 (1) [back to overview]Clinical Response to Crenolanib With Standard Salvage Chemotherapy
NCT02642965 (11) [back to overview]Liposome-encapsulated Cytarabine Clearance
NCT02642965 (11) [back to overview]Liposome-encapsulated Cytarabine Time of Maximum Concentration
NCT02642965 (11) [back to overview]Liposome-encapsulated Cytarabine Volume of Distribution
NCT02642965 (11) [back to overview]Liposome-encapsulated Daunorubicin Area Under the Curve
NCT02642965 (11) [back to overview]Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy
NCT02642965 (11) [back to overview]Liposome-encapsulated Daunorubicin Clearance
NCT02642965 (11) [back to overview]Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles
NCT02642965 (11) [back to overview]Liposome-encapsulated Daunorubicin Time of Maximum Concentration
NCT02642965 (11) [back to overview]Liposome-encapsulated Daunorubicin Volume of Distribution
NCT02642965 (11) [back to overview]Number of Participants With a Dose-limiting Toxicity
NCT02642965 (11) [back to overview]Liposome-encapsulated Cytarabine Area Under the Curve
NCT02652468 (7) [back to overview]Number of Participants With Severe Chronic GVHD
NCT02652468 (7) [back to overview]Number of Participants With Treatment-related Mortality
NCT02652468 (7) [back to overview]Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days
NCT02652468 (7) [back to overview]Overall Survival (OS)
NCT02652468 (7) [back to overview]Progression-free Survival
NCT02652468 (7) [back to overview]Number of Participants With Graft Failure
NCT02652468 (7) [back to overview]Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria
NCT02756572 (19) [back to overview]Acute Graft Versus Host Disease Among Patients Who Received Early Transplant
NCT02756572 (19) [back to overview]Demonstrate the Feasibility of Collecting Resource Utilization Data for Trial Participants
NCT02756572 (19) [back to overview]Event-free Survival (EFS) Among Patients Who Received Early Transplant
NCT02756572 (19) [back to overview]Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84
NCT02756572 (19) [back to overview]Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
NCT02756572 (19) [back to overview]Event-free Survival (EFS) Among Patients Who Received Early Transplant
NCT02756572 (19) [back to overview]Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE
NCT02756572 (19) [back to overview]Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - TREATMENT RELATED MORTALITY
NCT02756572 (19) [back to overview]Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
NCT02756572 (19) [back to overview]Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant
NCT02756572 (19) [back to overview]Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant
NCT02756572 (19) [back to overview]Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER
NCT02756572 (19) [back to overview]Treatment Related Mortality Among Patients Who Received Early Transplant vs Patients Who Did Not Receive Early Transplant
NCT02756572 (19) [back to overview]Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
NCT02756572 (19) [back to overview]Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
NCT02756572 (19) [back to overview]Overall Survival (OS) Among Patients Who Received Early Transplant.
NCT02756572 (19) [back to overview]Overall Survival (OS) Among Patients Who Received Early Transplant.
NCT02756572 (19) [back to overview]Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
NCT02756572 (19) [back to overview]Relapse-free Survival (RFS) Among Patients Who Received Early Transplant
NCT02757885 (12) [back to overview]Event-free Survival (EFS) Rate
NCT02757885 (12) [back to overview]Infection Rate
NCT02757885 (12) [back to overview]Frequency of Stroke
NCT02757885 (12) [back to overview]Frequency of Idiopathic Pneumonia Syndrome (IPS)
NCT02757885 (12) [back to overview]Late Graft Rejection Rate
NCT02757885 (12) [back to overview]Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease
NCT02757885 (12) [back to overview]Veno-occlusive Disease (VOD) Rate
NCT02757885 (12) [back to overview]Rate of Disease Recurrence
NCT02757885 (12) [back to overview]Rate of Central Nervous System (CNS) Toxicity
NCT02757885 (12) [back to overview]Primary Graft Rejection Rate
NCT02757885 (12) [back to overview]Overall Survival Rate
NCT02757885 (12) [back to overview]Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment.
NCT02774291 (1) [back to overview]Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0
NCT03071276 (3) [back to overview]Complete Response
NCT03071276 (3) [back to overview]Complete Response or Complete Response With Incomplete Count Recovery
NCT03071276 (3) [back to overview]The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)
NCT03128359 (3) [back to overview]Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading
NCT03128359 (3) [back to overview]Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year
NCT03128359 (3) [back to overview]Overall Survival (OS) at 1 Year
NCT03287674 (4) [back to overview]Overall Survival
NCT03287674 (4) [back to overview]Progression Free Survival
NCT03287674 (4) [back to overview]Treatment Related Immune Responses
NCT03287674 (4) [back to overview]Number of Participants With Reported Adverse Events by Type
NCT03813147 (8) [back to overview]Number of Participants With Adverse Events Attributable to MLN4924 (Pevonedistat)
NCT03813147 (8) [back to overview]Number of Participants With Antitumor Activity of MLN4924 (Pevonedistat)
NCT03813147 (8) [back to overview]Number of Participants With Dose Limiting Toxicities of MLN4924 (Pevonedistat)
NCT03813147 (8) [back to overview]Total Plasma Clearance of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
NCT03813147 (8) [back to overview]Maximum Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
NCT03813147 (8) [back to overview]Elimination Half-life of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
NCT03813147 (8) [back to overview]Area Under the Plasma Concentration Versus Time Curve of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
NCT03813147 (8) [back to overview]Maximum Time to Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS
NCT03873805 (2) [back to overview]Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
NCT03873805 (2) [back to overview]Grade 3 Toxicity Profile

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00001586)
Timeframe: 13 years, 10.5 months

InterventionParticipants (Number)
Intermediate-high Risk B-Cell Pts18

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Change in Gene Expression Post Chemo

Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells. (NCT00001586)
Timeframe: 6 hours post treatment, and 24 hours post treatment

InterventionPercent change in cells (Number)
6 hours post treatment (e.g. ># cells)24 hours post treatment (e.g. > # cells)
Intermediate-high Risk B-Cell Pts3050

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Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease

The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol. Immunophenotypic analysis of bone marrow and/ or peripheral blood demonstrate a normal k:λ ratio and a normal number of CD5/CD19 (or CD5/CD20) dual staining cells (<5% of the lymphocyte gate). (NCT00003659)
Timeframe: 3 years

Interventionparticipants (Number)
Flow cytometric complete responseMolencular (PCR) complete response
Intermediate or High Risk Chronic Lymphocytic Leukemia2012

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Overall Survival Status

The 5 year survival rate. The survival of patients with this disease is dependent on the stage of disease. Two useful staging systems are: Three-stage Rai System Clinical Feature and the Binet System. (NCT00003659)
Timeframe: up to 5 years

Interventionparticipants (Number)
Intermediate or High Risk Chronic Lymphocytic Leukemia26

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Overall Response Rate

Response was determined as indicated in the protocol. The categories are: complete response, nodular partial response, partial response and failure. The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. The laboratory and radiographic studies which were abnormal pre-study, will be repeated to document the degree of maximal response. (NCT00003659)
Timeframe: 3 years

Interventionparticipants (Number)
Complete ResponseNodular Partial ResponsePartial ResponseFailure
Intermediate or High Risk Chronic Lymphocytic Leukemia22284

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4 yr OS

Overall survival estimate at 4 years post BMT (NCT00003816)
Timeframe: 4-year

Interventionpercentage of participants (Number)
BuCy56.4
CyTBI56.5
FluMel38.2
VpCyTBI39.1
Other53.3

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Toxicity/TRM at Day 100

Death due to treatment related causes before day +100 after BMT (NCT00003816)
Timeframe: Day +100

InterventionParticipants (Count of Participants)
BuCy3
CyTBI4
FluMel31
VpCyTBI4
Other4

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CR Rate

Rate of Complete Remission by Day +100 (NCT00003816)
Timeframe: day 100

InterventionParticipants (Count of Participants)
BuCy42
CyTBI55
FluMel134
VpCyTBI18
Other7

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4 Year PFS

progression free survival estimate at 4 years post BMT (events are disease progression/relapse and death due to any cause) (NCT00003816)
Timeframe: 4 years

Interventionpercentage of participants (Number)
BuCy49.1
CyTBI52.2
FluMel33.2
VpCyTBI26.1
Other40

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Engraftment of HLA Identical PBSC Allografts

"Number of patients who engrafted by Day 56 post allogeneic transplant. Failure to engraft is defined as the absence of detectable donor cells in the marrow. The rates and accompanying confidence intervals associated with failure of engraftment at day +56 will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)." (NCT00005803)
Timeframe: Day 56

InterventionParticipants (Count of Participants)
Treatment (Tandem Transplantation)53

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Non-Relapse Mortality

"The rates and accompanying confidence intervals associated with transplant-related mortality will be calculated after every 5th patient is enrolled on the study. If the lower limit to the appropriate one-sided 80% confidence interval exceeds 25%, this will be considered sufficient evidence of an excess failure rate and the study will be stopped. For these purposes, all patients will be evaluated together (patients with chemosensitive and chemoresistant disease)." (NCT00005803)
Timeframe: Day 100 post-non-myeloablative allografting following mobilization and high-dose chemotherapy with autografting

InterventionParticipants (Count of Participants)
Treatment (Tandem Transplantation)3

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Overall Survival (OS)

Number of patients surviving by interval. Chemosensitive and chemoresistant subjects will be analyzed separately. (NCT00005803)
Timeframe: From the date of autologous transplant until the time of death, assessed up to 3 years

,,
InterventionParticipants (Count of Participants)
6 Months1 Year1.5 Years2 Years3 Years
Chemoresistant Group1410988
Chemosensitive Group3931272623
Unknown Chemosensitivity Group10000

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Progression Free-survival (PFS)

Number of patients surviving without disease by interval. Chemosensitive and chemoresistant subjects will be analyzed separately. (NCT00005803)
Timeframe: From the date of autologous transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission, assessed up to 3 years

,,
InterventionParticipants (Count of Participants)
6 Months1 Year1.5 Years2 Years3 Years
Chemoresistant Group128888
Chemosensitive Group3627252522
Unknown Chemosensitivity Group10000

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00006184)
Timeframe: 9 years

InterventionParticipants (Count of Participants)
Recipient - Chemotherapy Group10
Donor - Vaccination Generation Group10

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Immune Response

Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells. (NCT00006184)
Timeframe: 105 days

InterventionParticpants (Number)
Recipient - Chemotherapy Group7

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Overall Survival

(NCT00027560)
Timeframe: 12 months post transplant

Interventionparticipants (Number)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES37

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Overall Survival

(NCT00027560)
Timeframe: 24 months post transplant

Interventionparticipants (Number)
TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES30

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Leukemia-free Survival

Number of patients surviving in CR up to five years post-transplant. (NCT00036738)
Timeframe: Assessed up to 5 years

InterventionParticipants (Count of Participants)
6 Months1 Year2 Years3 Years4 Years5 Years
Treatment (Allogeneic Nonmyeloablative HSCT)191713111110

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Relapse Free Survival

Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission. (NCT00036738)
Timeframe: Assessed up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Nonmyeloablative HSCT)3

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Overall Survival

Number of patients surviving up to five years post-transplant. (NCT00036738)
Timeframe: Assessed up to 5 years

InterventionParticipants (Count of Participants)
6 Months1 Year2 Years3 Years4 Years5 Years
Treatment (Allogeneic Nonmyeloablative HSCT)262419171613

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Number of Participants With Absolute Neutrophil Count Engraftment

Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant. (NCT00038857)
Timeframe: Day 0 up to Day 30

Interventionparticipant (Number)
Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC21

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Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.

Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells. (NCT00040846)
Timeframe: 100 days after transplant

Interventionpercentage of participants (Number)
CD3 - Graft rejectionCD3 - Mixed chimerismCD3 - Full donor chimerismCD3 - UnknownCD33 - Graft RejectionCD33 - Mixed chimerismCD33 - Full donor chimerismCD33 - Unknown
Dose Level 1 (No Campath)3.318.3708.331.73.38015

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Evaluate the Risk of Occurrence of Acute and Chronic GVHD

"Percentage patients who developed acute/chronic GVHD.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00040846)
Timeframe: 1 year after transplant

Interventionpercentage of participants (Number)
Grade III-IV aGVHDcGVHD
Dose Level 1 (No Campath)23.341.7

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Evaluate the Risk/Incidence of Infections

Percentage patients who experienced infections within 100 days post-transplant. (NCT00040846)
Timeframe: 100 days after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)91.7

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Evaluate the Risk for Disease Progression and Relapse

Percentage patients who relapsed/progressed within 1 year post-transplant. (NCT00040846)
Timeframe: 1 year after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)21.7

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Early Post Transplantation Relapse

Participants who experienced recurrence or progression of disease following transplant. (NCT00043979)
Timeframe: up to 300 days

InterventionDays (Median)
Arm 2-Recipients100

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Median Progression Free Survival

Progression free survival was based on the time from on-study date until progression or last follow-up. (NCT00043979)
Timeframe: up to 77 months

InterventionMonths (Median)
Arm 2-Recipients15.9

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Median Time to Reach a Platelet Count of 50,000/mm(3)

Days for participants to achieve a platelet count of 50,000/mm(3). (NCT00043979)
Timeframe: up to 43 days

InterventionDays (Median)
Arm 2-Recipients15

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Median Time to Reach Absolute Neutrophil Count of 500/mm(3)

Days for participants to achieve a neutrophil count of 500/mm(3). (NCT00043979)
Timeframe: up to 12 days

InterventionDays (Median)
Arm 2-Recipients9

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Number of Participants With Engraftment

Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients. (NCT00043979)
Timeframe: 100 days

InterventionParticipants (Number)
Arm 2-Recipients23

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Toxicity

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00043979)
Timeframe: 16.5 months

InterventionParticipants (Number)
Arm 2-Recipients30

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Best Response Post-Hematopoietic Stem Cell Transplant EOCH (Etoposide, Vincristine, Cyclophosphamide, and Doxorubicin)

Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). RECIST criteria offer a simplified, conservative, extraction of imaging data for wide application in clinical trials. They presume that linear measures are an adequate substitute for 2-D (dimensional) methods and registers four response categories: Complete response (CR) is disappearance of all target lesions. Partial response (PR) is 30% increase in the sum of the longest diameter of target lesions. Progressive disease (PD) is 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) is small changes that do not meet above criteria. For the purposes of this study very good partial response ((VGPR) is >75% reduction in disease) was also employed. (NCT00043979)
Timeframe: up to 10 cycles of therapy or 280 days

InterventionParticipants (Count of Participants)
Complete Response (CR)Progressive Disease (PD)Partial Response (PR)Very Good Partial Response (VGPR)
Arm 2-Recipients2442

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Median Survival From Date of Progression

Median survival from date of progression is based on the time from on-study date until progression or last follow-up. (NCT00043979)
Timeframe: up to 77 months

InterventionMonths (Median)
Participants who did not receive a transplant(n=7)Participants who received a transplant (n=23)
Arm 2-Recipients3.319.1

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Two Year Survival Rate for Patients Undergoing Allo-Hematopoietic Stem Cell Transplant

Participants who are alive at two years following Allo-Hematopoietic Stem Cell Transplant. (NCT00043979)
Timeframe: 2 years

Interventionpercentage of participants (Number)
From date of enrollmentFrom date of transplantation
Arm 2-Recipients39.134.8

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Number of Participants to Complete Conversion to >95% Donor Chimerism

Participants who tolerated the transplantation regimen and accepted >95% of the donors blood, marrow, and/or tissue. (NCT00043979)
Timeframe: up to 30 days

InterventionParticipants (Count of Participants)
Day +14Day +28
Arm 2-Recipients2323

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Number of Participants With Acute and Chronic GVHD

Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100. (NCT00043979)
Timeframe: up to 5 years or death

,
Interventionparticipants (Number)
acute GVHDchronic GVHD
Recipients -Cyclosporine GVHD Prophylaxis1212
Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis55

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Post-Hematopoietic Stem Cell Transplant (HSCT) Radiotherapy

Site of radiotherapy (high energy radiation) and/or toxicity experienced by the participants post HSCT radiotherapy. Grading was preformed using the Modified Glucksberg Criteria. (NCT00043979)
Timeframe: up to 6 cycles or 168 days

InterventionParticipants (Count of Participants)
Chest wall; G2 skinAbdomen; G4 GIPancreas; G4 LFTs, G4 pancreatitisPleura, mediastinum; G4 LFTs, G2 mucositisChest wall; G4 skin, G3 mucositisSpine, skull; G2 nausea+vomiting, G2 fatiguePelvis; G4 enteritisPulmonary (cyberknife)Brain; B3 mucositisWhole lung; G3 mucositis, G3 skin, G5 lungL arm, R shoulder, B/L femur
Arm 2-Recipients11111111111

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Number of Participants Who Experienced Graft Versus Tumor Effect (GVT)

GVT is defined as tumor response after day 42 post-transplantation without cytotoxic therapy. (NCT00043979)
Timeframe: up to day 100

InterventionParticipants (Count of Participants)
Arm 2-Recipients0

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Cluster of Differentiation 4 (CD4) Reconstitution

The median CD4 count with a range of 85-1565 (absolute count) was used to determine recovery and were considered recovered if in this range. The CD4 count was established by flow cytometry testing. (NCT00043979)
Timeframe: Day +28-42

Interventionmm(3) (Median)
Arm 2-Recipients284

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Incidence of Acute and Chronic GVHD

Percent patients with acute/chronic GVHD (NCT00045435)
Timeframe: aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.

Interventionpercentage of participants (Number)
Grade II-IV aGVHDcGVHD
Treatment (Nonmyeloablative Donor PBSC Transplant)35.335.3

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Incidence of Relapse

Percent patients with relapsed disease post-transplant. (NCT00045435)
Timeframe: By 1 year after transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative Donor PBSC Transplant)41.2

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Incidence of Rejection

Percent patients who developed infections post-transplant. (NCT00045435)
Timeframe: By 1 year after transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative Donor PBSC Transplant)0

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Disease-free Survival-incidence of Survival Without Relapse

Sufficient evidence will be taken to be an observed rate of DFS at one year after transplant that corresponds to a one-sided 95% confidence interval with an upper limit lower than 35%. (NCT00045435)
Timeframe: By 1 year after transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative Donor PBSC Transplant)47

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Nonrelapse Mortality (NRM)-Incidence of Nonrelapse Death

Defined as death without morphologic evidence of disease. Sufficient evidence will be taken to be an observed rate of NRM within 200 days of transplant that corresponds to a one-sided 80% confidence interval with a lower limit greater than 15%. (NCT00045435)
Timeframe: 200 days after transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative Donor PBSC Transplant)6

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Overall Survival

Percent patients surviving. (NCT00045435)
Timeframe: By 1 year after transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative Donor PBSC Transplant)70.6

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Number of Participants With Graft Failure

Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells. (NCT00048737)
Timeframe: 100 days

Interventionparticipants (Number)
90Y Zevalin in ASCT1

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Number of Participants With Adverse Events

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00048893)
Timeframe: 91 months

InterventionParticipants (Number)
Carcinoembryonic Antigen (CEA)-Tricom Vaccines11

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Incidence of Grades III-IV Acute GVHD

Grade III GVHD represents moderate severity. Grade IV GVHD represents extreme severity (NCT00049504)
Timeframe: At any time within 200 days after transplantation

InterventionParticipants (Count of Participants)
Treatment (Nonmyeloablative HSCT)4

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Donor Engraftment (Chimerism)

Defined by the detection of at least 50% donor derived T-cells (CD3+), as a proportion of the total T-cell population (NCT00049504)
Timeframe: At day +84 after transplantation

InterventionParticipants (Count of Participants)
Treatment (Nonmyeloablative HSCT)34

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Acute GvHD

overall grade II-IV acute GvHD (NCT00053989)
Timeframe: Day +100

InterventionParticipants (Count of Participants)
All Patients16

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Day 100 TRM

treatment related mortality within 100 days from hematopoietic stem cell (HSC) infusion on day 0 (NCT00053989)
Timeframe: from start or conditioning (day -6 or -5) through day +100 after HSC infusion

InterventionParticipants (Count of Participants)
All Patients4

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OS

Overall survival with events defined as death due to any cause and censored patients are alive as of 1 year post HSC infusion (NCT00053989)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Patients44

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PFS

Progression free survival defined as time from HSC infusion (day 0) until progression of disease or death due to any cause. Patients are censored if alive without disease progression through 1 year after HSC infusion (NCT00053989)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Patients27

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Incidence of Chronic (Extensive) GVHD

Number of subjects with chronic extensive GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Related Donor4
Unrelated Donor1

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Engraftment

Number of subjects who engrafted post-transplant. Engraftment will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Related Donor12
Unrelated Donor4

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Incidence of Acute GVHD (Grades III-IV)

Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion. (NCT00054353)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Related Donor2
Unrelated Donor0

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Response Rate

Number of subjects who achieved CR post-transplant. Response rate will be summarized using cumulative incidence estimates. (NCT00054353)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Related Donor2
Unrelated Donor1

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OS

Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated. (NCT00054353)
Timeframe: At 6 months and then every year thereafter, up to 5 years

,
InterventionParticipants (Count of Participants)
6 Months1 Year2 Years3 Years4 Years5 Years
Related Donor854333
Unrelated Donor320000

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Relapse Rate

Number of subjects who relapsed after achieving CR post-transplant. Relapse rate will be summarized using cumulative incidence estimates. (NCT00054353)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Related Donor1
Unrelated Donor1

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PFS

PFS will be calculated for all patients from the date of transplant until the time of progression, relapse, death, or the date the patient was last known to be in remission. Progressive disease is defined as greater than 25% increase in serum or urine M proteins compared to best response status after autologous transplant and/or appearance of new lytic bone lesions or plasmocytomas. (NCT00054353)
Timeframe: At 1 year post-transplant

InterventionParticipants (Count of Participants)
Related Donor4
Unrelated Donor1

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Non-relapse Mortality

Early NRM will be monitored in a sequential fashion. (NCT00054353)
Timeframe: At day 100

InterventionParticipants (Count of Participants)
Related Donor1
Unrelated Donor1

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Rate and Types of Infections

Number of infections patients experienced, by infection type. (NCT00060424)
Timeframe: 18 months

Interventioninfections (Number)
ViralFungalFever of unknown originBacterialOther
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)27136535

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Acute Grade II-IV GVHD and Chronic (Extensive) GVHD

"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00060424)
Timeframe: aGVHD: 100 days after transplant; cGVHD: 1 Year after transplant.

InterventionParticipants (Count of Participants)
Acute GVHDChronic extensive GVHD
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)1010

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Rate of Relapse

Number of patients with relapsed disease post-transplant. Relapse/progression is defined as 1) Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, 2) circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, or 3) lymph node Biopsy Richter's transformation. (NCT00060424)
Timeframe: 18 months

InterventionParticipants (Count of Participants)
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)8

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Overall Survival

Number of patients surviving 18 months post-transplant. (NCT00060424)
Timeframe: At 18 months

InterventionParticipants (Count of Participants)
Treatment (Enzyme Inhibitor, Transplant, GVHD Prophylaxis)15

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Rate of Chronic GVHD

Number of participants who present GVHD post-transplant and display features of chronic GVHD. Diagnostic and distinctive features of chronic GVHD are present. There are no features of acute GVHD. (NCT00067002)
Timeframe: Up to one year

,
InterventionParticipants (Count of Participants)
Overall Chronic GVHDLimitedExtensive
Expanded CB Arm201413
Un-Manipulated CB Arm16109

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Number of Participants Severity of Acute GVHD by Treatment Arm

The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. The stages of individual organ involvement is assessed using Glucksberg grade (I-IV) where Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. (NCT00067002)
Timeframe: Following first 100 days, up to one year

,
InterventionParticipants (Count of Participants)
Grade ≤ 2Grade ≥ 3No GVHD
Expanded CB Arm15227
Un-Manipulated CB Arm20619

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Time To Neutrophil Engraftment

Engraftment is defined as a sustained ANC > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment date is the first of the 3 days with sustained absolute neutrophil count (ANC) >/= 0.5 x 10^9/L. (NCT00067002)
Timeframe: First 100 days, evaluation and blood tests twice weekly

InterventionDays (Median)
Un-Manipulated CB Arm17
Expanded CB Arm15

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Rate of Acute Graft Versus Host Disease (GVHD)

Number of participants who display features of acute GVHD within 100 days of transplant. (NCT00067002)
Timeframe: Review over first 100 days

InterventionParticipants (Count of Participants)
Un-Manipulated CB Arm29
Expanded CB Arm24

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Number of Participants With Engraftment

Engraftment defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for at least 3 consecutive days. Engraftment Failure defined as ANC <500/ul by day +42 and participant has no evidence of donor chimerism on bone marrow examination. (NCT00067002)
Timeframe: First 100 days, evaluation and blood tests twice weekly

InterventionParticipants (Count of Participants)
Un-Manipulated CB Arm45
Expanded CB Arm44

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Non-relapse Mortality (NRM)

Percentage of patients who died due to causes other than relapse (NCT00070135)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)16

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2 Year DFS for All Patients

Percentage of participants who were alive and relapse free at 2 years for all patients. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method. (NCT00070135)
Timeframe: Up to 2 years

Interventionpercentage of participants (Number)
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)42

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2 Year Disease Free Survival In Unrelated Donor Recipient Group

"Percentage of participants who were alive and relapse free at 2 years for patients who were matched with an unrelated donor for transplant. The 2 year disease free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A relapse is defined as any of the following:~Reappearance of leukemia blasts cells in peripheral blood~>5% blasts in the marrow, not attributable to another cause (e.g., bone marrow regeneration)~If there are no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow ≥ 1 week later with >5% blasts is necessary to meet the criteria for relapse~The development of extramedullary leukemia or leukemic cells in the cerebral spinal fluid" (NCT00070135)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Treatment (Fludarabine, Busulfan, Allogeneic PBSC)40

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Number of Participants With Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes

Long-term Engraftment of Allogeneic Stem Cells and Lymphocytes based on cell counts of ANC >1000 for 3 consecutive days and platelet count of >50,000 (NCT00074269)
Timeframe: 30 days post transplant

InterventionParticipants (Count of Participants)
Treatment5

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Overall Survival

(NCT00074269)
Timeframe: 1 year from the time of transplant

Interventiondays (Median)
Treatment279.4

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Progression-free Survival

Progression assessed by CT scan (NCT00074269)
Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Interventiondays (Median)
Treatment110

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Response as Measured at 12 Months Post Allografting

response (partial and complete) assessed by CT scan at 12 months post allografting (NCT00074269)
Timeframe: From date of transplant until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

InterventionParticipants (Count of Participants)
Treatment3

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Frequency of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1 Month Post Allografting

(NCT00074269)
Timeframe: 1 month post allografting

InterventionParticipants (Count of Participants)
Treatment5

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Number of Participants With Acute and Chronic Graft-versus-host Disease (GVHD)

(NCT00074269)
Timeframe: 100 days post transplant

InterventionParticipants (Count of Participants)
Treatment3

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Number of Participants With Adverse Events

(NCT00074269)
Timeframe: 5 years post transplant

InterventionParticipants (Count of Participants)
Treatment5

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Incidence of Chronic Extensive GVHD

Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)72
Arm II (TBI, Transplant, GVHD Prophylaxis)48

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Incidence of Grades II-IV Acute GVHD

Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 120 days after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)46
Arm II (TBI, Transplant, GVHD Prophylaxis)32

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Incidence of Graft Rejection

Donor CD3 chimerism less than 5% (NCT00075478)
Timeframe: 1 year after transplant

Interventionparticipants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)0
Arm II (TBI, Transplant, GVHD Prophylaxis)2

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Incidence of Non-relapse Mortality

Percentage of NRM as estimated by cumulative incidence methods with competing risks (NCT00075478)
Timeframe: 3 years after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)7
Arm II (TBI, Transplant, GVHD Prophylaxis)9

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Incidence of Relapse/Progression

Percentage of relapse estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)40
Arm II (TBI, Transplant, GVHD Prophylaxis)55

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Overall Survival

Percentage of patients surviving as estimated by Kaplan-Meier. (NCT00075478)
Timeframe: 3 years after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)65
Arm II (TBI, Transplant, GVHD Prophylaxis)54

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Progression-free Survival

Percentage of patients with progression-free survival, estimated by cumulative incidence methods (NCT00075478)
Timeframe: 3 years after transplant

Interventionpercentage of participants (Number)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)53
Arm II (TBI, Transplant, GVHD Prophylaxis)36

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Relapse-free Complete Clinical Response

Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of ≤3; prednisone ≤10mg/day at 6 months and ≤5mg/day at 12 months or later. (NCT00076752)
Timeframe: 60 months

InterventionMonths (Median)
Autologous HSCT in SLE54

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Absolute Lymphocyte Count

The absolute lymphocyte count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 0.45-4.9 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE0.540.00650.420.530.821.751.81.81.75

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Absolute Neutrophil Count

The absolute neutrophil count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 1.29-7.5 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE5.660.459.112.722.783.442.724.043.77

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Anti-Double Stranded Deoxyribonucleic Acid (DNA) Antibody

Anti-Double stranded deoxyribonucleic acid antibody is a well accepted biological clinical laboratory marker especially specific for systemic lupus. Range of normal values is 0-24 IU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionIU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE17.38.80000000

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Anti-Nuclear Antibody

Anti-Nuclear antibody is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-0.9 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years 9
Autologous HSCT in SLE5.44.73.73.22.72.62.82.52.5

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Anti-Smith-Ribonuclear Protein Antibody

Anti-Smith-Ribonuclear protein antibody is a well accepted biological clinical laboratory marker of systemic lupus.Range of normal values is 0-19 EU. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months and 2 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years
Autologous HSCT in SLE4951.631.529.828.52016.6725.67

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Cluster of Differentiation 19 (CD19) + Cells

The CD19 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 47-409 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year3 years
Autologous HSCT in SLE0.010.236.745.32142.69246.83

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Cluster of Differentiation 3 (CD3) + Cells

The CD3+Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 650-2108 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE2.99239.47435.97699.471493.291678.76

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Cluster of Differentiation 4 (CD4) + Cells

The CD4 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 358-1259 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE2.58103.37112.8316.25702.87958.03

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Cluster of Differentiation 8 (CD8) + Cells

The CD8 + Cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 194-836 u/L. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year2 years
Autologous HSCT in SLE0.34138.68318.47334.91736.67674.69

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Extractable Nuclear Antigen (ENA)

Extractable nuclear antigen is a well accepted biological clinical laboratory marker of systemic lupus. Range of normal values is 0-19. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionEU (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE66.964.861.558.551.357.260.650.626.3

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Natural Killer Cells

The natural killer cells test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 87-505 uL. (NCT00076752)
Timeframe: Day 0, 1 month, 3 months, 6 months, 1 year and 2 years.

Interventioncells/mL^3 (Mean)
Day 01 month3 months6 months1 year3 years
Autologous HSCT in SLE0.03117.06116.57123.18158.9115.18

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Platelet Count

The platelet count test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 162-380 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE251113166187170226210308272

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Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

The SLEDAI activity index test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Complete clinical response is defined as complete clinical response in the target organ and no clinical signs of active lupus as determined by a SLEDAI score of ≤3; partial response is at least 50% improvement in general disease activity as measured by SLEDAI. Remission is a SLEDAI score <3 and prednisone <10mg/day. 6+ indicates active disease requiring therapy. A score of 0 indicates a better outcome and a score greater then 6+ indicates a worse outcome. (NCT00076752)
Timeframe: Day -7, day 0, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years and 3 years.

Interventionscores on a scale. (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE4.254.133.631.600000

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White Blood Cells

The white blood cell test was performed to investigate immunological efficacy and mechanisms of response after lymphodepleting auto-hematopoietic stem cell transplant for systemic lupus erythematosus. Range of normal values is 3.4-9.6 K/uL. (NCT00076752)
Timeframe: Day -7, day 0, 1 3, and 6 months, 1 year, 18 months, 2 years and 3 years.

InterventionK/uL (Mean)
Day -7Day 01 month3 months6 months1 year18 months2 years3 years
Autologous HSCT in SLE6.890.4710.323.844.215.815.247.176.34

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00076752)
Timeframe: 18 months

Interventionparticipants (Number)
Autologous HSCT in SLE8

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Number of Participants With Lymphocyte Recovery as Measured by Blood Count

Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame. (NCT00085423)
Timeframe: on days 1-15, weekly for 2 weeks, and then every 2-3 months

Interventionparticipants (Number)
Group 118

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Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST

Objective response as measured by radiological and physical examination using RECIST criteria. (NCT00085423)
Timeframe: Response at 12 weeks

Interventionparticipants (Number)
Group 13

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Time to Progression as Measured by RECIST

Clinical outcome used the National Cancer Institute's Response Evaluation Criteria in Solid Tumors (RECIST)1.0. (NCT00085423)
Timeframe: From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months

Interventionyears (Mean)
Group 1.3

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Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)

AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau). (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)

Interventionng*h/mL (Mean)
Combination Arm (FluCAM)8203
Fludarabine Alone5669

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Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)

Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)27.96
Fludarabine Alone18.68

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Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)

Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)25.10
Fludarabine Alone19.14

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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment

Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)23.65
Fludarabine Alone16.48

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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II

Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)23.75
Fludarabine Alone20.76

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Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV

Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)20.53
Fludarabine Alone11.51

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Kaplan-Meier Estimates for Time to Alternative Therapy

Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)25.43
Fludarabine Alone22.01

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Kaplan-Meier Estimates of Overall Survival Time

Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)NA
Fludarabine Alone52.93

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Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II

Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)NA
Fludarabine AloneNA

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Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV

Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV. (NCT00086580)
Timeframe: Up to 6 years

Interventionmonths (Median)
Combination Arm (FluCAM)NA
Fludarabine Alone23.52

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Maximum Plasma Concentration (Cmax) of Fludarabine

Cmax is the maximum plasma concentration of fludarabine observed. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)

Interventionng/mL (Mean)
Combination Arm (FluCAM)4084
Fludarabine Alone1847

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Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline

EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). (NCT00086580)
Timeframe: Day 0 (baseline)

Interventionunits on a scale (Mean)
Combination Arm (FluCAM)0.7959
Fludarabine Alone0.7822

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Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment

EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59). (NCT00086580)
Timeframe: up to month 6 (end of treatment)

Interventionunits on a scale (Mean)
Combination Arm (FluCAM)0.8049
Fludarabine Alone0.7749

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Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline

"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom." (NCT00086580)
Timeframe: Day 0 (baseline)

Interventionunits on a scale (Mean)
Combination Arm (FluCAM)70.9
Fludarabine Alone70.2

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Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment

"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom." (NCT00086580)
Timeframe: up to month 6 (end of treatment)

Interventionunits on a scale (Mean)
Combination Arm (FluCAM)77.1
Fludarabine Alone75.7

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Mean Systemic Clearance (CL) of Fludarabine

Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)

Interventionliters/hour (Mean)
Combination Arm (FluCAM)9.46
Fludarabine Alone9.54

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Participants With Minimal Residual Disease (MRD)

MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome. (NCT00086580)
Timeframe: up to 9 months

Interventionparticipants (Number)
Combination Arm (FluCAM)6
Fludarabine Alone0

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Total Volume of Distribution (Vss) of Fludarabine

The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data. (NCT00086580)
Timeframe: month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)

Interventionliters (Mean)
Combination Arm (FluCAM)117
Fludarabine Alone172

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Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)

Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology. (NCT00086580)
Timeframe: Up to 9 months

,
Interventionparticipants (Number)
Overall Response (CR+PR)Complete Response (CR)Partial Response (PR)Progressive Disease (PD)Stable Disease (SD)Not Evaluable (NE)
Combination Arm (FluCAM)1372111661213
Fludarabine Alone126711992111

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Summary of Participants With Adverse Experiences (AEs)

Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab. (NCT00086580)
Timeframe: Up to 6 years

,
Interventionparticipants (Number)
At least 1 treatment emergent AEAt least 1 related treatment emergent AEAt least 1 treatment-emergent infectionAt least 1 drug-related infectionAt least 1 serious AEAt least 1 related serious AEDiscontinuation of study drug due to AEDiscontinuation of study drug due to related AEDeathsPatients who died due to a related AEPatients who died within 30 days of the last dose
Combination Arm (FluCAM)1611596744544737321074
Fludarabine Alone1491255830412832241267

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Incidence of Chronic Extensive GVHD

Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. (NCT00089011)
Timeframe: Day 180 post-transplantation

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)15
Arm II (Nonmyeloablative Conditioning With TBI)6

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Incidence of Grade III/IV GVHD

"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00089011)
Timeframe: Day 180 post-transplantation

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)2
Arm II (Nonmyeloablative Conditioning With TBI)4

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Incidences of Grades II-IV Acute GVHD

"Number of patients who developed acute/chronic GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 3 skin and/or stage 1 gut involvement and/or stage 1 liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00089011)
Timeframe: Day 180 post-transplantation

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)26
Arm II (Nonmyeloablative Conditioning With TBI)14

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Incidences of Graft Rejection

Number of patients who rejected their graft. Rejection is defined as the inability to detect or loss of detection of greater than 5% donor T cells (CD3+) as a proportion of the total T cell population, respectively, after nonmyeloablative HCT. (NCT00089011)
Timeframe: Day 180 post-transplantation

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)0
Arm II (Nonmyeloablative Conditioning With TBI)0

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Overall Survival

Number of patients surviving post-transplant. (NCT00089011)
Timeframe: At 1 year after conditioning

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)85
Arm II (Nonmyeloablative Conditioning With TBI)39

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Rate and Duration of Steroid Use for the Treatment of Chronic GVHD

Number of patients that received prednisone treatment of chronic GVHD, and number of days for which they received prednisone. (NCT00089011)
Timeframe: Up to 5 years

Interventiondays (Median)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)78
Arm II (Nonmyeloablative Conditioning With TBI)89

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Rates of Disease Progression

"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~CMML, AML, ALL >30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia.~CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions." (NCT00089011)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Arm I (Nonmyeloablative Conditioning With Fludarabine and TBI)41
Arm II (Nonmyeloablative Conditioning With TBI)33

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Number of Participants With Overall Survival (OS) Events

Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

,
Interventionparticipants (Number)
Patients with eventPatients without events
Fludarabine+Cyclophosphamide (FC)68208
Fludarabine+Cyclophosphamide+Rituximab (FCR)62214

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Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)

Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

,
Interventionparticipants (Number)
Patients with eventPatients without events
Fludarabine+Cyclophosphamide (FC)148128
Fludarabine+Cyclophosphamide+Rituximab (FCR)137139

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Final Analysis: Duration of Response

Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)869.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1333.0

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Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)660
Fludarabine+Cyclophosphamide+Rituximab (FCR)813

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Disease-free Survival (DFS)

Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1285
Fludarabine+Cyclophosphamide+Rituximab (FCR)1204

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Event-free Survival (EFS)

Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)586
Fludarabine+Cyclophosphamide+Rituximab (FCR)874

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Final Analysis: Percentage of Participants With Complete Response

Complete response was defined as the disappearance of all signs of cancer in response to treatment. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionPercentage of participants (Number)
Fludarabine+Cyclophosphamide (FC)13.4
Fludarabine+Cyclophosphamide+Rituximab (FCR)25.0

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Final Analysis: Time to Disease-Free Survival Event

Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1285.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1803.0

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Final Analysis: Time to Event-Free Survival Event

Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)630.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)932.0

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Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment

Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1085.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1625.0

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Final Analysis: Time to Overall Survival Event

Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)2056.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)2167.0

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Final Analysis: Time to Progression-Free Survival Event

Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first. (NCT00090051)
Timeframe: Median observation time was approximately 5 years

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)683.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)969.0

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Overall Survival (OS)

Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1580
Fludarabine+Cyclophosphamide+Rituximab (FCR)NA

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Number of Participants With Disease-free Survival (DFS) Events

Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

,
Interventionparticipants (Number)
Patients with eventPatients without event
Fludarabine+Cyclophosphamide (FC)1026
Fludarabine+Cyclophosphamide+Rituximab (FCR)1948

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Number of Participants With Event-free Survival (EFS) Events

Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date. (NCT00090051)
Timeframe: Mean observation time at time of analysis was approximately 26 months

,
Interventionparticipants (Number)
Patients with eventPatients without events
Fludarabine+Cyclophosphamide (FC)162114
Fludarabine+Cyclophosphamide+Rituximab (FCR)134142

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Duration of Response

(NCT00096018)
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years

Interventionmonths (Mean)
Phase I - Dose Escalation43.3
Phase II30.0

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Overall Responders (Complete and Partial Response)

Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.) (NCT00096018)
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 years

Interventionparticipants (Number)
Phase I - Dose Escalation8
Phase II18

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Clinical Tumor Regression

Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. (NCT00096382)
Timeframe: Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.

,
InterventionParticipants (Number)
Complete ResponsePartial Response
TBI 200cGy + TIL +HD IL-2, No Prior IL-212
TBI 200cGy + TIL +HD IL-2, Prior IL-219

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Safety

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. (NCT00096382)
Timeframe: 4 years

InterventionParticipants (Number)
TBI 200cGy + TIL +HD IL-2, Prior IL-223
TBI 200cGy + TIL +HD IL-2, No Prior IL-23

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Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab

"Response, as defined by the National Cancer Institute Working Group (NCIWG):~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions" (NCT00098670)
Timeframe: Up to 9 months

Interventionparticipants (Number)
Alemtuzumab Consolidation92

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2 Year Survival

Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method. (NCT00098670)
Timeframe: 2 years from registration

Interventionpercentage of participants (Number)
Alemtuzumab Consolidation86

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2 Year Progression Free Survival

Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method. (NCT00098670)
Timeframe: 2 years from registration

Interventionpercentage of participants (Number)
Alemtuzumab Consolidation72

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Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab

"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy" (NCT00098670)
Timeframe: Duration of treatment (up to 13.5 months)

Interventionparticipants (Number)
Alemtuzumab Consolidation38

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Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab

"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death." (NCT00098670)
Timeframe: 6 weeks beginning at study week 36

Interventionparticipants (Number)
Alemtuzumab Consolidation23

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Number of Patients Achieving Complete Response and Partial Response (Overall Response Rate)

"Complete Remission (CR):~Imaging studies (Xray, CT, MRI) (nodes, liver, and spleen): Normal Peripheral blood by flow cytometry: No clonal lymphocytes Bone marrow by morphology: No nodules; or if present, nodules are free from CLL cells by immunohistochemistry Duration: ≥2 months~CR with minimal residual disease Peripheral blood or bone marrow by flow cytometry: >0 - <1 CLL cells/1000 leukocytes (0.1%)~Partial Remission (PR):~Both criteria:~Absolute lymphocyte count in peripheral blood: ≥50% decrease Physical exam/Imaging studies (nodes, liver, and/or spleen): ≥50% decrease Duration: ≥2 months" (NCT00104858)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Rituximab Followed by HCT)35

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Overall Survival

Number of participants surviving post-transplant (NCT00104858)
Timeframe: At 18 months

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Rituximab Followed by HCT)34

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Donor and Host Polymorphisms of the FCgammaRIIIa Receptor and CD32 and Their Impact on Disease Response and Relapse

Number of participants without progressive disease and surviving at one year. Participants with FCgammaRIIIa receptor vs participants without FCgammaRIIIa receptor. (NCT00104858)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Surviving participants w/ FCgammaRIIIa receptorSurviving participants w/o FCgammaRIIIa receptorw/ FCgammaRIIIa receptor w/o progressive diseasew/o FCgammaRIIIa receptor w/o progressive disease
Treatment (Chemotherapy and Rituximab Followed by HCT)221219

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Rituxan Concentration

Median rituxan level at days 60, 84, 180, and 1 year. (NCT00104858)
Timeframe: Days 60, 84, 180, and 1 year

Interventionug/ml (Median)
Day 60Day 84Day 1801 year
Treatment (Chemotherapy and Rituximab Followed by HCT)109511.3.03

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Number of Participants With Grade II-III and III-IV Acute GVHD and Chronic GVHD

"Number of patients who developed acute GVHD post-transplant. Grade I +1 to +2 skin rash, No gut or liver involvement Grade II +1 to +3 skin rash, +1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or +2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD." (NCT00104858)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Rituximab Followed by HCT)46

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Number of Participants With Relapse/Progression

"Relapse/Progression criteria for CLL~Progressive disease:~≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~Relapsed disease:~Criteria of progression occurring 6 months after achievement of complete or partial remission." (NCT00104858)
Timeframe: Day 84

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Rituximab Followed by HCT)1

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Number of Participants With Grades II-IV Acute GVHD

"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT00105001)
Timeframe: 150 days after transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and Tacrolimus)44
Arm II (MMF and Tacrolimus Alternate Schedule)34
Arm III (MMF, Tacrolimus, and Sirolimus)32

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Number of Participants Utilizing High-Dose Corticosteroids

"Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 150 days after transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and Tacrolimus)38
Arm II (MMF and Tacrolimus Alternate Schedule)35
Arm III (MMF, Tacrolimus, and Sirolimus)22

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Number of Participants Surviving Without Progression

"Number of patients with progression-free survival, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 2 Years post-transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and Tacrolimus)28
Arm II (MMF and Tacrolimus Alternate Schedule)27
Arm III (MMF, Tacrolimus, and Sirolimus)26

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Number of Participants Surviving Overall

"Number of patients surviving, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and Tacrolimus)48
Arm II (MMF and Tacrolimus Alternate Schedule)47
Arm III (MMF, Tacrolimus, and Sirolimus)40

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Number of Non-Relapse Mortalities

"Percentage of NRM as estimated by cumulative incidence methods with competing risks.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref) Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198" (NCT00105001)
Timeframe: 200 days after transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and Tacrolimus)3
Arm II (MMF and Tacrolimus Alternate Schedule)6
Arm III (MMF, Tacrolimus, and Sirolimus)2

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Overall Survival

Kaplan-Meier estimate assessed at 1 year. (NCT00112593)
Timeframe: Up to 1 year

Interventionsurvival probability (Number)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)0.40

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Death From Regimen Toxicity or Opportunistic Infection

(NCT00112593)
Timeframe: Within the first 100 days

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)0

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Death From GVHD

(NCT00112593)
Timeframe: Within the first 360 days

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)0

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Successful Induction of Mixed Hematopoietic Chimerism as Assessed by the Percentage of Peripheral Blood T Cells That Are of Donor Origin

Determined by a DNA-based assay that compares the profile of amplified fragment length polymorphisms (ampFLP) of the patient and donor. (NCT00112593)
Timeframe: Up to day 80

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)5

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Reconstitution of HIV-specific Immunity

(NCT00112593)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)2

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Progression of HIV

Count of participants with HIV progression. (NCT00112593)
Timeframe: Within 1 year

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Hematopoietic Stem Cell Transplantation)0

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Disease Progression/Relapse

"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions." (NCT00118352)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)25

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Incidence of Infection

Percentage patients that experienced infection(s). (NCT00118352)
Timeframe: Up to 5 years post-transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)100

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Incidence of Grade III-IV Acute GVHD

"Severity of Individual Organ Involvement~Liver:~Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml~Gut:~Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall~Severity of GVHD~Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 2 to 4 liver involvement with or without a rash Grade IV - Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00118352)
Timeframe: 100 days after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)25

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Incidence of Graft Rejection

Percentage patients that experienced graft rejection. (NCT00118352)
Timeframe: 84 days after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)0

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Incidence of High-dose Corticosteroid Utilization.

Percentage patients requiring steroids greater than 1 mg/kg. (NCT00118352)
Timeframe: 100 days after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)83.3

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Incidence of Non-relapse Mortality

Percentage patient deaths due to non-relapse mortality (NCT00118352)
Timeframe: 100 days after transplant

Interventionpercentage of participants (Number)
Dose Level 1 (No Campath)8.3

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Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen

"Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.~Normalization of blood counts (no blasts, platelets >100,000/mm3, granulocytes >1,500/mm3).~No extramedullary disease." (NCT00119366)
Timeframe: 2 years post transplant

InterventionParticipants (Count of Participants)
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody0
Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody2
Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody1
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody0
Dose Level 10: 28 Gy Iodine-131+ BC82

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Number of Participants With 100% Donor Chimerism at Day 28 and Day 84

Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis (NCT00119366)
Timeframe: Day 28 and Day 80 after transplant

,,,,
InterventionParticipants (Count of Participants)
Day 28 Donor ChimerismDay 84 Donor Chimerism
Dose Level 1: 12 Gy Iodine-131+ BC8 Monoclonal Antibody00
Dose Level 10: 28 Gy Iodine-131+ BC874
Dose Level 7: 22 Gy Iodine-131+ BC8 Monoclonal Antibody11
Dose Level 8: 24 Gy Iodine-131+ BC8 Monoclonal Antibody33
Dose Level 9: 26 Gy Iodine-131+ BC8 Monoclonal Antibody22

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Participant Disease Response Within 4 Weeks After Transplant

"The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant.~Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis.~Normalization of blood counts (no blasts, platelets >100,000/mm3, granulocytes >1,500/mm3).~No extramedullary disease.~Relapse is measured as follows:~After CR: >5% blasts in the bone marrow and/or peripheral blood.~Confirmation of relapse by bone marrow analysis with more than 10% blasts.~Extramedullary disease confirmed cytologically or histologically." (NCT00119366)
Timeframe: 4 weeks after transplant

,,,,
InterventionParticipants (Count of Participants)
Number of participants that are in CR 4 weeks after transplantNumber of participants that relapsed 4 weeks after transplant
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody01
Dose Level 10: 28 Gy Iodine-131 + BC8 Monoclonal Antibody62
Dose Level 7: 22 Gy Iodine-131 + BC8 Monoclonal Antibody20
Dose Level 8: 24 Gy Iodine-131 + BC8 Monoclonal Antibody30
Dose Level 9: 26 Gy Iodine-131 + BC8 Monoclonal Antibody11

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Overall and Progression-free Survival

Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years. (NCT00119392)
Timeframe: Up to 8 years

Interventionpercent (Number)
Overall survivalProgression free survival
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)5431

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Response Rates

(NCT00119392)
Timeframe: Up to 8 years

InterventionParticipants (Count of Participants)
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)25

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Engraftment and Hematopoietic Toxicity

Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter. (NCT00119392)
Timeframe: At day +100

Interventiondays (Median)
NeutrophilsPlatelets
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)1711

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Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.

(NCT00119392)
Timeframe: At day +84

InterventionParticipants (Count of Participants)
Acute GVHD: Grade 1-2Acute GVHD: Grade 3Chronic extensive GVHD
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)2745

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Overall Survival

OS rate at 1 year. (NCT00121186)
Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

Interventionparticipants (Number)
Nonmyeloablative Allogeneic Stem Cell Transplant1

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Progression-free Survival

PFS rate at 1 year. (NCT00121186)
Timeframe: 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration

Interventionparticipants (Number)
Nonmyeloablative Allogeneic Stem Cell Transplant1

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Progression-free Survival

Percentage of participants who do not experience disease relapse, disease progression, or death. (NCT00134004)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Mini-haplo BMT34

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Relapse Rate

Percentage of participants who experience disease relapse. (NCT00134004)
Timeframe: Cumulative incidence for the entire study, up to 11 years

Interventionpercentage of participants (Number)
Mini-haplo BMT55

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Hematologic and Non-hematologic Toxicities as Measured by NCI Common Toxicity Criteria for Adverse Events, v 3.0 Weekly Until 1 Year After Transplantation

Percentage of study participants who experienced a serious adverse event (SAE) within 1 year of bone marrow transplant. Complete data is provided in the Adverse Event tables. (NCT00134004)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Mini-haplo BMT9.5

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Graft Failure Rate

Percentage of participants who experienced failure to engraft (also called graft failure or graft rejection). Failure to engraft is defined as <5% donor chimerism and absence of relapse or any other reason for that chimerism value. All participants who met this criterion were included in this outcome measure. (NCT00134004)
Timeframe: Cumulative incidence for the entire study, up to 11 years

Interventionpercentage of participants (Number)
Mini-haplo BMT13

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Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment

"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: 2 years

Interventionunits on a scale (Median)
RIC Bu/Flu (A) (Discontinued)100
MA Bu/Cy (B)100
RIC Cy/Flu/TBI (A2)100

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Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment

"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: 1 year

Interventionunits on a scale (Median)
RIC Bu/Flu (A) (Discontinued)97
MA Bu/Cy (B)100
RIC Cy/Flu/TBI (A2)100

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The Incidence of Chimerism at 100 Days

The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)1
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)11

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Overall Survival

Number of patients alive 1 year after transplant. (NCT00176852)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)3
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)12

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Overall Survival

Number of patients alive 100 days after transplant. (NCT00176852)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)3
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)12

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The Incidence of Chimerism at 1 Year

The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)1
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)8

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The Incidence of Chimerism at 6 Months

The number of patients whose blood and/or bone marrow contains > 10% donor cells. (NCT00176852)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)1
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)8

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The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)

The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant. (NCT00176852)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)0
MA Bu/Cy (B)0
RIC Cy/Flu/TBI (A2)0

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The Incidence of Chronic Graft Versus Host Disease (Chronic GVHD)

The number of patients who experienced Chronic GVHD. Chronic GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Chronic GVHD can appear at any time after allogeneic transplant or several years after transplant. (NCT00176852)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)0
MA Bu/Cy (B)0
RIC Cy/Flu/TBI (A2)0

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The Incidence of Grade 2-4 Acute Graft Versus Host Disease (Acute GVHD)

The number of patients who experienced grades 2-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. Grades 2-4 equate to mild to severe disease. Symptoms typically appear within weeks after transplant. (NCT00176852)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)0
MA Bu/Cy (B)0
RIC Cy/Flu/TBI (A2)0

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The Incidence of Grade 3-4 Acute Graft Versus Host Disease (Acute GVHD)

The number of patients who experienced grades 3-4 Acute GVHD. Acute GVHD is when the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body. IGrades 3-4 equate to moderate to severe disease. Symptoms typically appear within weeks after transplant. (NCT00176852)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)0
MA Bu/Cy (B)0
RIC Cy/Flu/TBI (A2)0

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Disease Free Survival

Number of patients alive without disease 100 days after transplant. (NCT00176852)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)3
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)11

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Disease Free Survival

Number of patients alive without disease 1 year after transplant. (NCT00176852)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
RIC Bu/Flu (A) (Discontinued)3
MA Bu/Cy (B)5
RIC Cy/Flu/TBI (A2)11

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Change in the Patient's Quality of Life as Compared to the Pre-Transplant Assessment

"The measure for quality of life used in this study is the Karnofsky Performance Score. The Karnofsky Performance Score runs from 100 to 0, where 100 is perfect health and 0 is death." (NCT00176852)
Timeframe: pre-transplant

Interventionunits on a scale (Median)
RIC Bu/Flu (A) (Discontinued)100
MA Bu/Cy (B)98
RIC Cy/Flu/TBI (A2)99

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Number of Patients With Chronic Graft Versus Host Disease

Number of patients who exhibited chronic (normally occurs after 100 days) Graft Versus Host Disease at 2 years post transplant. Chronic graft-versus-host-disease, over its long-term course, can also cause damage to the connective tissue and exocrine glands. (NCT00176878)
Timeframe: 2 years

InterventionParticipants (Number)
Bone Marrow Failure Patients3

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Number of Patients With Succcessful Engraftment After Transplantation

"Number of patients who received non-genotypic identical marrow or cord blood cells using a non-myeloablative preparative regimen and exhibited engraftment at Day 42." (NCT00176878)
Timeframe: 42 Days

InterventionParticipants (Number)
Bone Marrow Failure Patients10

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Number of Patients With Grade 2-4 Acute Graft Versus Host Disease

Number of patients with Grade 2, 3 and 4 Acute (normally observed within the first 100 days) Graft Versus Host Disease. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of 1 to a high of 4. Patients with grade IV GVHD usually have a poor prognosis. Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening. (NCT00176878)
Timeframe: 100 Days

InterventionParticipants (Number)
Bone Marrow Failure Patients5

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Number of Patients With Disease Recurrence

Number of patients who exhibited disease recurrence at 2 years. (NCT00176878)
Timeframe: 2 years

InterventionParticipants (Number)
Bone Marrow Failure Patients0

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Number of Patients Alive at Three Years (Survival)

Number of subjects who survived 3 years post-transplant. (NCT00176878)
Timeframe: 3 years

InterventionParticipants (Number)
Bone Marrow Failure Patients6

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Number of Patients Alive (Survival) at 2 Years

Calculated from day 1 of transplant to last contact. (NCT00176878)
Timeframe: 2 years

InterventionParticipants (Number)
Bone Marrow Failure Patients6

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Relapse Mortality

The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate. (NCT00245037)
Timeframe: Years 1 and 2

Interventionpercentage of analyzed participants (Number)
Year 1Year 2
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)1320

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Acute Graft-Versus-Host Disease (aGVHD) Outcome

"Grading of Acute GVHD:~Severity of Individual Organ Involvement:~Skin~1 a maculopapular eruption involving less than 25% of the body surface~2 a maculopapular eruption involving 25-50% of the body surface~3 generalized erythroderma~4 generalized erythroderma with bullous formation and/or with desquamation Liver~1 bilirubin 2.0-3.0mg/100mL~2 bilirubin 3-5.9mg/100mL~3 bilirubin 6-14.9mg/100mL~4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea~1 <1000mL of liquid stool/day~2 >1,000mL of stool/day~3 >1,500mL of stool/day~4 2,000mL of stool/day, severe abdominal pain, with or without ileus~Severity of GVHD:~Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver" (NCT00245037)
Timeframe: Day 100, Month 6

Interventionpercentage of analyzed participants (Number)
Day 100Month 6
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)5560

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Progression-Free Survival

"The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.~Definition of Disease Progression:~MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.~CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.~AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.~CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.~MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence." (NCT00245037)
Timeframe: Years 1, 2, 3, and 5

Interventionpercentage of analyzed participants (Number)
Year 1Year 2Year 3Year 5
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)48393529

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Overall Survival

The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5. (NCT00245037)
Timeframe: Years 1, 2, 3 and 5

Interventionpercentage of analyzed participants (Number)
Year 1Year 2Year 3Year 5
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)60484229

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Chronic Graft-Versus-Host Disease (cGVHD) Outcome

"Grading of Chronic GVHD:~Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD~Extensive:~One or more of the following:~Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ~Chronic GVHD Severity:~Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.~Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.~Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy" (NCT00245037)
Timeframe: Years 1, 2 and 3

Interventionpercentage of analyzed participants (Number)
Year 1Year 2Year 3
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)64.66667.3

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Non-relapse Mortality

Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. (NCT00245037)
Timeframe: Two years post-transplant

InterventionParticipants (Count of Participants)
Year 1Year 2
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)2733

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Number of Participants Who Developed Acute Graft Versus Host Disease

(NCT00255684)
Timeframe: 3 months

Interventionparticipants (Number)
Conditioning Therapy Followed by TBI0

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Number of Participants Who Survived 100 Days or Longer

(NCT00255684)
Timeframe: 100 days

Interventionparticipants (Number)
Conditioning Therapy Followed by TBI13

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Number of Participants Experiencing Relapse

Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. (NCT00258427)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm2
Marrow Clinimacs1
Sibling withoutCliniMACS0

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Number of Participants Experiencing Overall Survival

Overall Survival - Number of patients alive at 1 year post transplant (NCT00258427)
Timeframe: 1 Year

InterventionParticipants (Count of Participants)
Marrow Isolex1
USB Arm4
Marrow Clinimacs1
Sibling withoutCliniMACS1

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Number of Participants Experiencing Major Infections

Number of participants experiencing Major Infections by the end of treatment (NCT00258427)
Timeframe: Day 1 through 1 year post-transplant

InterventionParticipants (Count of Participants)
Marrow Isolex3
USB Arm8
Marrow Clinimacs2
Sibling withoutCliniMACS1

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Number of Participants Experiencing Acute Graft-Versus-Host Disease

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm1
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Acute Graft-Versus-Host Disease

Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00258427)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Chronic Graft-Versus-Host Disease

Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. (NCT00258427)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Marrow Isolex0
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Participants Experiencing Graft Failure

Graft failure is defined as absolute neutrophil count( ANC ) <5 x 10^8/L by day 30. (NCT00258427)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
Marrow Isolex1
USB Arm0
Marrow Clinimacs0
Sibling withoutCliniMACS0

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Number of Patients With Natural Killer (NK) Cell Expansion

Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14). (NCT00274846)
Timeframe: Study Day 14

InterventionParticipants (Number)
Patients With Relapsed/Refractory AML - Evaluable Group2

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Overall Survival Time of Patients With Complete Remission

Median number of months patients were alive after NK cell infusion. (NCT00274846)
Timeframe: From Day 1 of Treatment until death or patient received bone marrow transplant.

InterventionMonths (Median)
Patients Achieving Complete Remission - Responders13

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Number of Patients With Complete Remission

Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery). (NCT00274846)
Timeframe: Day 28-35

InterventionParticipant (Number)
Patients With Relapsed/Refractory AML - Evaluable Group2

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Median Time to Disease Relapse (Months)

Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood. (NCT00274846)
Timeframe: From 1st Day of treatment until death or receipt of bone marrow transplant.

InterventionMonths (Median)
Patients Achieving Complete Remission - Responders7.3

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Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months

,
InterventionDays to an event (Number)
Minimum number of days to an eventMaximum number of days to an event
Fludarabine+Cyclophosphamide (FC)841164
Fludarabine+Cyclophosphamide+Rituximab (FCR)911226

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Overall Survival (OS)

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months

,
InterventionDays (Number)
Minimum number of days to an eventMaximum number of days to an event
Fludarabine+Cyclophosphamide (FC)51373
Fludarabine+Cyclophosphamide+Rituximab (FCR)41372

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Event-free Survival (EFS)

Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)947.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1212.0

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Final Analysis: Duration of Response

Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1102.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1718.0

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Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionPercentage of participants (Number)
Fludarabine+Cyclophosphamide (FC)72.4
Fludarabine+Cyclophosphamide+Rituximab (FCR)85.8

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Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)

CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1488.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1854.0

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Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. (NCT00281918)
Timeframe: Median observation time at time of analysis was approximately 21 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)981.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1212.0

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Final Analysis: Time to Event-free Survival Event

Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)951.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1666.0

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Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)

The time from randomization to the start of a new treatment. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)1455.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)2082.0

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Final Analysis: Time to Overall Survival Event

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)2613.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)NA

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Final Analysis: Time to Progression-free Survival Event

Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first. (NCT00281918)
Timeframe: Median observation time was approximately 66.4 months

InterventionDays (Median)
Fludarabine+Cyclophosphamide (FC)998.0
Fludarabine+Cyclophosphamide+Rituximab (FCR)1703.0

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Tolerance and Efficacy of Maintenance Therapy With Rituximab

"To assess the tolerance and efficacy of maintenance therapy with rituximab. Participants proceeded to the rituximab maintenance program of 6 treatments comprising 1 every 2 months. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as CR unconfirmed on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as > 50% increase in the size of liver and/or spleen, or a > 50% increase in absolute number of circulating lymphocytes." (NCT00290511)
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 years

InterventionParticipants (Count of Participants)
Complete Response (CR)Progression Disease (PD)
R-FIND + Zevalin383

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Median Progression Free Survival

Progression-free survival time is defined as time from registration/randomization to the date of progression or death from any cause. Median Progression Free Survival estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval. (NCT00290511)
Timeframe: up to 5 years

Interventionmonths (Median)
R-FIND + Zevalin84

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Overall Survival

OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Median Overall Survival was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval. (NCT00290511)
Timeframe: up to 5 years

Interventionmonths (Number)
R-FIND + Zevalin143

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Percentage of Participants With Overall Survival Rate at 10 Years

OS is defined as the interval from first dose of study treatment to the date of death, irrespective of the cause of death; subjects still alive will be censored at the date of the last contact. Overall Survival Rate estimated by the method of Kaplan and Meier. (NCT00290511)
Timeframe: 10 years

Interventionpercentage of participants (Number)
R-FIND + Zevalin69

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Progression Free Survival at 10 Years

Progression-free survival time is defined as time from registration/randomization to the date of progression or death from any cause. PFS was estimated by the method of Kaplan and Meier, and accompanied by 95% confidence interval. (NCT00290511)
Timeframe: 10 years

Interventionmonths (Number)
R-FIND + Zevalin49

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Number of Participants With Time to Progression (TTP)

Regimen regarded as a success if median TTP can be prolonged to 36 months or greater. Time to Progression measured by the method of Kaplan and Meier, and accompanied by 95% confidence interval. Complete Response (CR) defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays and Partial Response (PR) is defined as a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. av (NCT00290511)
Timeframe: baseline, 2 and 4 courses, approximately month 8, 9, and 12 months, then restaging every 4 months, then at 2 years every 4-6 months, then yearly until progressive disease or lost to follow up, average of 10 years

InterventionParticipants (Count of Participants)
Complete Response (CR)Partial Response (PR)
R-FIND + Zevalin424

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Tolerance and Efficacy of Maintenance Therapy With Yttrium-90 Ibritumomab Tiuxetan (YIT)

"To assess the tolerance and efficacy of maintenance therapy with YIT. CR: defined as those who achieve a normal state which includes no detectable evidence of disease on x-rays. CRu: defined as CR unconfirmed on the basis of minimal residual abnormalities on x-ray such as a residual mass <25% of original measurement, and or residual indeterminate bone marrow aggregates. PR: a 50% or more reduction in the sum of the products of the diameters of the 6 largest measurable lesions. No new sites of disease. Progressive disease (PD) is also defined by the appearance of new lymph nodes, of other new or worsening sites of disease, such as > 50% increase in the size of liver and/or spleen, or a > 50% increase in absolute number of circulating lymphocytes." (NCT00290511)
Timeframe: cycle 1 and every 2 weeks thereafter until completion of therapy, an average of 10 years

InterventionParticipants (Count of Participants)
Complete Response (CR)Progressive Disease
R-FIND + Zevalin371

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Disease-free Survival With Correction of Disease at One Year Post Transplantation

"Patients deemed alive and well at follow-up timepoint later than 1-year post-transplantation" (NCT00301834)
Timeframe: 1 year post-transplantation

Interventionparticipants (Number)
Single Arm - Transplant Pre-conditioning Per Study Protocol22

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Number of Participants Achieving Durable Engraftment (Presence of Donor Cells) at 6 Weeks Post Transplantation

Peripheral blood chimerism studies were performed by quantitative real time polymerase chain reaction (qPCR) evaluation of differential short tandem repeat DNA sequences (NCT00301834)
Timeframe: 6 weeks post-transplant

Interventionparticipants (Number)
Single Arm - Transplant Pre-conditioning Per Study Protocol31

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Cytomegalovirus (CMV) Viral Infection and Disease Symptoms

polymerase chain reaction testing for presence of CMV weekly until at least day +100 then every 2 weeks until T-cell reconstitution as defined by cluster of differentiation 4 (CD4) > 200 cells/mm3. Median time to T-cell reconstitution was 6 months. (NCT00301834)
Timeframe: Up to one year post-transplant

,
Interventionparticipants (Number)
Positive CMV Viral Load AssaySymptomatic CMV disease
CMV Seronegative Participants10
CMV Seropositive Participants120

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Toxicity Grade ≥ 3 From Start of Conditioning Through the First Year Post Transplantation

(NCT00301834)
Timeframe: 1 year post-transplantation

Interventionparticipants (Number)
Grade 3-4 acute Graft-Versus-Host DiseaseGrade 3-4 mucositis
Single Arm216

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Treatment-related Mortality at 100 Days and 1 Year Post Transplantation

(NCT00301834)
Timeframe: 100 days and 1 year

Interventionparticipants (Number)
Transplantation-related mortality 0-100 daysTransplantation-related mortality 100-365 days
Single Arm - Transplant Pre-conditioning Per Study Protocol21

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Number of Patients With Graft Failure

Number of patients with graft failure defined as <500 donor neutrophils count by day 28 in the absence of residual or relapsed leukemia (NCT00303667)
Timeframe: Day 28

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema1
SCT w/Donor Natural Killer Cells - Extended Schema4

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Disease-free Survival at 1 Year

Number of patients alive without evidence of disease at 1 year after transplant (NCT00303667)
Timeframe: 1 Year

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema0
SCT w/Donor Natural Killer Cells - Extended Schema3

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Number of Patients With Disease Relapse

Disease relapse is the recurrence of leukemia in patients who had cleared their leukemia after treatment. Patients with persistent leukemia are not evaluable for relapse. (NCT00303667)
Timeframe: 1 Year

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema5
SCT w/Donor Natural Killer Cells - Extended Schema12

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Incidence of Post-transplant Lymphoproliferative Disorder (PTLD)

Post-transplant lymphoproliferative disorder (PTLD) is a virally-driven cancer of the lymphoid cells caused by immunosuppressive drugs taken after allogeneic stem cell transplantation to prevent or control graft versus host disease. (NCT00303667)
Timeframe: 1 Year

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema0
SCT w/Donor Natural Killer Cells - Extended Schema3

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Incidence of Grade III-IV Acute Graft Versus Host Disease

Grade III-IV acute graft versus host disease is a severe short term complication created by infusion of donor cells into a foreign host (NCT00303667)
Timeframe: Month 6

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema0
SCT w/Donor Natural Killer Cells - Extended Schema0

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Incidence of Chronic Graft Versus Host Disease

Chronic graft versus host disease is a severe long term complication created by infusion of donor cells into a foreign host (NCT00303667)
Timeframe: 1 Year

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema0
SCT w/Donor Natural Killer Cells - Extended Schema0

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In Vivo Expansion of a Donor NK Cells NK Cell Product

Number of patients with in vivo expansion of donor NK cells. In vivo expansion of NK cell is defined as detection of >100 donor-derived NK cells per microliter of blood. (NCT00303667)
Timeframe: 12 - 14 days after NK cell infusion

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Extended Schema19

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Disease-free Survival at 6 Months

Number of patients alive without evidence of disease at 6 months after transplant (NCT00303667)
Timeframe: Month 6

Interventionparticipants (Number)
SCT w/Donor Natural Killer Cells - Short Schema0
SCT w/Donor Natural Killer Cells - Extended Schema4

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Percentage Chimerism on Day 100

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Day 100

Interventionpercentage of donor cells (Mean)
Unrelated UCBT for Blood Cancers98.1

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Percentage Chimerism at 1 Year

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: 1 Year

Interventionpercentage of donor cells (Mean)
Unrelated UCBT for Blood Cancers99.1

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Percentage Chimerism at 2 Years

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: 2 Years

Interventionpercentage of donor cells (Mean)
Unrelated UCBT for Blood Cancers100

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Number of Participants With Neutrophil Engraftment

Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC > 5 x 10^8/L of donor origin by day +42) (NCT00309842)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Unrelated UCBT for Blood Cancers21

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Number of Participants With Chronic Graft-Versus-Host Disease

"Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00309842)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Unrelated UCBT for Blood Cancers39

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Number of Participants Who Were Alive at 1 Year Transplant Overall Survival

Number of patients alive at 1 year after transplant. (NCT00309842)
Timeframe: at 1 year

InterventionParticipants (Count of Participants)
Unrelated UCBT for Blood Cancers130

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Percentage Chimerism on Day 21

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Day 21

Interventionpercentage of donor cells (Mean)
Unrelated UCBT for Blood Cancers92.6

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Number of Participants Who Died Due to Transplant

Determine the incidence of transplant-related mortality at 6 months after UCBT (NCT00309842)
Timeframe: At Month 6

InterventionParticipants (Count of Participants)
Unrelated UCBT for Blood Cancers58

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Number of Participants With Acute Graft-Versus-Host Disease

"Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD.~Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level." (NCT00309842)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Grade II-IVGrade III-IV
Unrelated UCBT for Blood Cancers10649

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Number of Participants With Platelet Engraftment

Determine the incidence of platelet engraftment (platelet recovery >50,000/uL) at 6 months after UCBT. (NCT00309842)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Unrelated UCBT for Blood Cancers159

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Percentage Chimerism at 6 Months

Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28. (NCT00309842)
Timeframe: Month 6

Interventionpercentage of donor cells (Mean)
Unrelated UCBT for Blood Cancers98.1

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Non-relapse Mortality

(NCT00322101)
Timeframe: At 100 days

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)0
Arm II (Myeloablative Regimen)0

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Overall Survival

(NCT00322101)
Timeframe: At 2 years

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)6
Arm II (Myeloablative Regimen)6

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Progression-free Survival

IWG criteria was used to determine disease progression (NCT00322101)
Timeframe: After stem cell infusion to date of last follow up.

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)7
Arm II (Myeloablative Regimen)5

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Donor Cell Engraftment

Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%. (NCT00322101)
Timeframe: After stem cell infusion to day 28

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)11
Arm II (Myeloablative Regimen)11

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Incidence and Severity of Acute and Chronic Graft-vs-host Disease

(NCT00322101)
Timeframe: After transplantation

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)1
Arm II (Myeloablative Regimen)4

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Incidence of Disease Progression/Relapse

Disease progression/relapse was defined by IWG criteria (NCT00322101)
Timeframe: After stem cell infusion to date of last follow up.

Interventionparticipants (Number)
Arm I (Nonmyeloablative Regimen)7
Arm II (Myeloablative Regimen)2

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Number of Participants (Patients) Who Attained Neutrophil Engraftment

"Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days.~ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3)." (NCT00354172)
Timeframe: Day 42 Post Transplant

InterventionParticipants (Number)
Evaluable Patients13

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Number of Participants (Patients) Who Attained Platelet Engraftment

Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients5

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Number of Participants (Patients) Who Died by 12 Months

Number of patients who died after receiving treatment within 12 months post transplant. (NCT00354172)
Timeframe: 1 year Post Transplant

InterventionParticipants (Number)
Evaluable Patients14

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Number of Participants (Patients) Who Died by 24 Months

Number of patients who died after receiving treatment within 24 months post transplant. (NCT00354172)
Timeframe: 2 years post-transplant

InterventionParticipants (Number)
Evaluable Patients15

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Number of Participants (Patients) Who Died Due to Transplant.

Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients4

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Number of Participants (Patients) With Chronic Graft-Versus-Host Disease

The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. (NCT00354172)
Timeframe: Day 100 through 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Experienced Relapse by 24 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 2 Years Post transplant

InterventionParticipants (Number)
Evaluable Patients11

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Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months

Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. (NCT00354172)
Timeframe: 12 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months

Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. (NCT00354172)
Timeframe: 6 Months Post Transplant

InterventionParticipants (Number)
Evaluable Patients2

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Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 Post Transplant

InterventionParticipants (Number)
Evaluable Patients6

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Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV

Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. (NCT00354172)
Timeframe: Day 100 post transplant

InterventionParticipants (Number)
Evaluable Patients1

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Number of Participants (Patients) Who Experienced Relapse by 12 Months

Number of patients who experienced recurrence or progression of disease from the time of transplant. (NCT00354172)
Timeframe: 1 Year Post Transplant

InterventionParticipants (Number)
Evaluable Patients10

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Number of Participants (Patients) With Successful Natural Killer Cell Expansion

Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population (NCT00354172)
Timeframe: 10-13 Days Post Infusion

InterventionParticipants (Number)
Evaluable Patients3

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Number of Patients Who Were Disease-free and Alive at 24 Months

Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. (NCT00354172)
Timeframe: 24 Months Post transplant

InterventionParticipants (Number)
Evaluable Patients0

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Chimerism After Double Umbilical Cord Blood Transplant (UCBT)

Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient). (NCT00354172)
Timeframe: Day 21, Day 100, 6 Months

InterventionPercentage of Engrafted Cells (Median)
Day 21Day 1006 Months
Evaluable Patients9210096.5

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Incidence of Grade III/IV Acute Graft Versus Host Disease (GVHD)

Number of patients diagnosed with overall GIII/IV acute GVHD by Day 100 (NCT00358657)
Timeframe: Day 100 post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)5

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Number of Patients With Infections

Number of patients with clinically significant infections requiring treatment within 200 days after HCT (NCT00358657)
Timeframe: Through day 200 after HCT

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)11

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Graft Failure

Number of patients with graft failure (grade IV thrombocytopenia and neutropenia after day 21 that lasts > 2 weeks andn is refractory to growth factor support). (NCT00358657)
Timeframe: Day 84

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)0

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Graft Rejection

Number of patients with graft rejection (CD3 donor chimerisms <5%). (NCT00358657)
Timeframe: Day 84

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)1

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Immune Reconstitution

Number of patients with normal range CD3 @ 1 year post transplant (NCT00358657)
Timeframe: 1 year post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)4

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Incidence of Chronic GVHD

Number of patients diagnosed with chronic GVHD by 1 year post transplant (NCT00358657)
Timeframe: 1 year post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)11

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Proportion of Patients Who Achieve Greater Than 5% Donor T-cell Chimerism

Number of patients who achieve greater than 5% donor T-cell (CD3+) chimerisms (NCT00358657)
Timeframe: By day 84

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)13

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Incidence of Grade I/II Acute Graft Versus Host Disease (GVHD)

Number of patients diagnosed with overall GI/G2 acute GVHD by Day 100 (NCT00358657)
Timeframe: Day 100 post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemo, Total-body Irradiation, Transplant)7

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Severe Venous Occlusive Disease (VOD)/ Sinusoidal Obstructive Syndrome (SOS)

The number of subjects with severe VOD / SOS; severity staged according to criteria set forth by McDonald G.B., Hinds M.S., Fisher L.D., et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118:255-267. Assessed within the first 100 days post transplant. (NCT00361140)
Timeframe: 100 days

Interventionparticipants (Number)
AUC 60000
AUC 75001
AUC 90002

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Non-relapse Mortality

The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant. (NCT00361140)
Timeframe: 100 days

Interventionparticipants (Number)
AUC 60003
AUC 75004
AUC 90002

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Number of Participants Progression-free

Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level > 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression. (NCT00381004)
Timeframe: 6 months or until disease progression if earlier

Interventionparticipants (Number)
FCR + Sargramostim60

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Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.

Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease. (NCT00381004)
Timeframe: Baseline to 6 Months

InterventionPercentage of Participants (Number)
FCR + Sargramostim100

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Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions.

Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)11 g/dL, absolute neutrophil count (ANC)>/=1.5x109/L, & platelet count>100x109/L. Bone marrow:<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb>11 g/dL or 50% improvement (imp.) in deviation, or ANC>/=1.5x109/L or 50% imp., or platelet>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC11 g/dL, ANC>/=1.5x109/L & platelet count>100x109/L; <30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression &/or appearance new malignant disease; Reappearance bone marrow disease. (NCT00381004)
Timeframe: Baseline to 6 Months

InterventionParticipants (Number)
Complete Response (CR)Nodular Partial Response (nPR)Partial Response (PD)
FCR + Sargramostim4569

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Response Rate Including Complete Response, Partial Response, and Hematological Improvement Assessed by Blood Cell Counts, Number of Blasts in Bone Marrow, and Clinical Evaluation

Bone marrow aspiration and biopsies were performed prior to treatment, during week 3 of the first cycle, at the time of hematologic recovery from all cycles of therapy (defined as neutrophil count >500/mm3 and platelets >20,000/mm3 independently of transfusion), or at any time that leukemia regrowth was suspected. The overall response rate was defined as complete remission, partial remission, or hematologic improvement, lasting for ≥30 days. Given the different subsets of diseases, standardized response criteria were used for CMML (the Myelodysplastic Syndrome International Working Group criteria),33 CMML transforming to acute myeloid leukemia (standard AML response criteria) , accelerated MPN (Giles et al.), and transformation of MPN to secondary AML (Mascarenhas et al.). (NCT00381550)
Timeframe: Up to 4 years

Interventionparticipants (Number)
Arm I18

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Survival at 1 Year After Transplantation

The number of patients survival status 1 year after transplantation (NCT00387959)
Timeframe: 1 Year after transplant

Interventionparticipants (Number)
Alive at 1 Year Post TransplantDied Prior to 1 Year Post Transplant
Unrelated Donor Umbilical Cord Transplant106

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Incidence of Disease-free Survival

Number of patients alive and without disease at 1 year after transplant. (NCT00392782)
Timeframe: 1 Year

InterventionParticipants (Number)
All Treated Patients18

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Incidence of Disease Relapse

Number of patients with disease at 1 year. (NCT00392782)
Timeframe: 1 Year

InterventionParticipants (Number)
All Treated Patients6

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Incidence of Chronic Graft-versus-host Disease (GVHD)

"Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD." (NCT00392782)
Timeframe: 1 Year

InterventionParticipants (Number)
All Treated Patients4

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Overall Survival

Number of patients who were deceased at 1 year post transplant. (NCT00392782)
Timeframe: 1 Year

InterventionParticipants (Number)
All Treated Patients10

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Incidence of Graft Failure

Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days. (NCT00392782)
Timeframe: Day 100

InterventionParticipants (Number)
All Treated Patients1

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Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)

"Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening." (NCT00392782)
Timeframe: Day 100

InterventionParticipants (Number)
All Treated Patients6

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The Number of Participants With Adverse Events

Here are the total number of participants with adverse events. Adverse events were described using the Common Terminology Criteria for Adverse Events (CTCAE) version 3. For the detailed list of adverse events see the adverse event module. (NCT00393029)
Timeframe: events related to all components of the treatment regimen were reported from the start of the non-myeloablative conditioning regiment through 30 days following treatment or resolution.

Interventionparticipants (Number)
Metastatic Melanoma2
Other Metastatic Cancers9

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In Vivo Survival of T-cell Receptor (TCR) Gene-engineered Cells in Participants

Survival of TCR gene-engineered cells is defined as >10% murine TCR positive cells. (NCT00393029)
Timeframe: 3-12 months

Interventionparticipants (Number)
Metastatic Melanoma2
Other Metastatic Cancers9

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Clinical Tumor Regression

"Response Evaluation Criteria In Solid Tumors (RECIST).~See the protocol Link module for full criteria if desired." (NCT00393029)
Timeframe: 1-11 months

InterventionParticipants (Number)
Metastatic Melanoma & Other Metastatic Cancers1

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Number of Patients With HCT Failure.

HCT failure will be defined as graft rejection (defined as < 5% donor T-cell chimerism) or disease progression within 200 days of transplant. (NCT00397813)
Timeframe: 200 days

InterventionParticipants (Count of Participants)
Arm A - Dose Level 14
Arm A - Dose Level 20
Arm A - Dose Level 30
Arm B - Dose Level 15
Arm B - Dose Level 23
Arm B - Dose Level 32

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Number of Patients Who Engrafted

Continued engraftment will be defined as the detection of donor T-cells (CD3+) as a proportion of the total T-cell of greater than 5%. (NCT00397813)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm A - Dose Level 135
Arm A - Dose Level 20
Arm A - Dose Level 30
Arm B - Dose Level 112
Arm B - Dose Level 24
Arm B - Dose Level 324

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Number of Patients Who Had Infections

Number of patients who experienced bacterial, fungal, or viral infections. (NCT00397813)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm A - Dose Level 124
Arm A - Dose Level 20
Arm A - Dose Level 30
Arm B - Dose Level 112
Arm B - Dose Level 24
Arm B - Dose Level 324

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Number of Patients With Progression-free Survival

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. (NCT00397813)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm A - Dose Level 124
Arm A - Dose Level 20
Arm A - Dose Level 30
Arm B - Dose Level 11
Arm B - Dose Level 22
Arm B - Dose Level 311

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Number of Patients With Relapse/Progression

Evidence of disease progression will be an indication for therapeutic intervention. Defined as any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of an incremental increase in 5% blasts in MDS/CMML; defined as any evidence of blastic transformation in agnogenic myeloid metaplasia/atypical CML; and defined as progressive erythrocytosis, thrombocytosis, or evidence of leukemic transformation in polycythemia vera and essential thrombocythemia. (NCT00397813)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Arm A - Dose Level 16
Arm A - Dose Level 20
Arm A - Dose Level 30
Arm B - Dose Level 16
Arm B - Dose Level 23
Arm B - Dose Level 36

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Time to Neutrophil Engraftment

(NCT00425802)
Timeframe: 2 years

Interventiondays (Median)
Treatment15

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Immune Reconstruction/CD4+ Count at 6 Months

(NCT00425802)
Timeframe: 6 months

Interventioncells/microliter (Median)
Treatment312

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Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days

(NCT00425802)
Timeframe: 100 days

Interventionpercentage of patients (Number)
Treatment18

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Incidence of Chronic GVHD at 1 Year

(NCT00425802)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Treatment14

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Immune Reconstruction/CD4+ Count at 3 Months

(NCT00425802)
Timeframe: 3 months

Interventioncells/microliters (Median)
Treatment253

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Overall Survival at 1 Year

(NCT00425802)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Treatment90

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Immune Reconstruction/CD4+ Count at 1 Year

(NCT00425802)
Timeframe: 1 year

Interventioncells/microliter (Median)
Treatment333

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Time to Platelet Engraftment

(NCT00425802)
Timeframe: 1 year

Interventiondays (Median)
Treatment12

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Number of Patients With Engraftment Response

Engraftment defined as (1) the first of three consecutive days of an Absolute neutrophil count (ANC) >500/mL (b) the first of seven consecutive days of an unsupported platelet count 20,000. Patient needs to survive at least 28 days to be evaluable for engraftment. Chimerism studies need to demonstrate donor-derived hematopoiesis (>90%) (NCT00427336)
Timeframe: First 100 days post transplant.

InterventionParticipants (Number)
Fludarabine + Cyclophosphamide + ATG9

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Number of Participants With Engraftment

Engraftment defined as first of three (3) consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L; assessed from baseline to 100 days post-engraftment. (NCT00427557)
Timeframe: Baseline to 100 days post-engraftment

Interventionparticipants (Number)
Fludarabine + Melphalan + Umbilical Cord Blood Unit27

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Incidence of Grade II-IV Acute Graft-Versus-Host-Disease (GVHD)

Determine the incidence of grade II-IV acute GVHD after administration of grafts when combined with Cyclosporine/Mycophenolate Mofetil for GVHD prophylaxis. GVHD assessments occur daily as an in patient and at each out patient visit. (NCT00429416)
Timeframe: Through 24 months post-treatment

Interventionparticipants (Number)
Developed grade II-IV GVHDDeveloped cGVHD (Chronic GVHD)
LLME to Decrease GVHD Following HSC T31

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Safety of CD34+ Stem Cell Infusions Followed by LLME as Measured by 100-Day Mortality

"Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events.~This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included." (NCT00429416)
Timeframe: Through 100 days post-transplant or death

Interventionparticipants (Number)
LLME to Decrease GVHD Following HSC T1

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Rate of Serious Infectious Complications

"Determine the rate of serious infectious complications. A serious infection will be defined as any requiring hospitalization or parenteral therapy.~CD4 counts will be measured monthly for the first 3 months after transplant." (NCT00429416)
Timeframe: Through 3 months post-transplant

Interventionparticipants (Number)
LLME to Decrease GVHD Following HSC T2

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Rate of Engraftment of Non-Myeloablative Transplants

Determine the engraftment rate of non-myeloablative transplants using CD34+ stem cells and LLME treated CD34- products. (NCT00429416)
Timeframe: Through 30 days post-transplant

Interventionparticipants (Number)
LLME to Decrease GVHD Following HSC T13

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Number of Patients Who Achieve a CD4 Count > 200/Micro-liters

Determine the number of patients who achieve a CD4 count > 200/micro-liters by 60 days after transplant. (NCT00429416)
Timeframe: Through 60 Days Post Transplant

Interventionparticipants (Number)
LLME to Decrease GVHD Following HSC T13

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Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL

ORR defined as CR and PR response where response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR). (NCT00448019)
Timeframe: Response assessed after three 4-week courses and after six courses, up to 24 weeks

Interventionpercentage of participants (Number)
FCR + Bevacizumab79

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Progression Free Survival (PFS) Rate

Progression free survival (PFS) was defined as the time from the start of treatment to progression, which included treatment failure, relapse, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00448019)
Timeframe: Baseline up to 5 years

InterventionMonths (Median)
FCR + Bevacizumab13.5

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Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)

Response criteria for Complete response (CR) - Nodes: None; Liver/Spleen Size: Not palpable; Symptoms: None; polymorphonuclear leukocytes (PMN): >1,500/μl; Platelets >100,000/μl; Hemoglobin (untransfused): >11,0 g/dl; Lymphocytes: <4,000/μl; Bone Marrow aspirate: <30% lymphocytes; Biopsy: No lymphocyte infiltrate; and for Partial Response (PR), Nodes: >/= 50% decrease; Liver/Spleen Size: >/= 50% decrease; Symptoms: None; Platelets >100,000/μl or > 50% improvement from baseline; Hemoglobin (untransfused): >11.0 g/dl or >50% improvement from baseline; Lymphocytes: >50% decrease; Biopsy: <30% lymphocytes with residual disease on biopsy for nodular PR (NPR). (NCT00448019)
Timeframe: Response assessed after three 4-week courses and after six courses, up to 24 weeks

Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)Nodular Partial Response (NPR)
FCR + Bevacizumab13248

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Complete or Mixed Donor Chimerism at 30, 60, and 90 Days Post-transplant

"Complete chimerism is defined as 100% donor cells detected, suggesting complete hematopoietic replacement. Mixed donor chimerism means host cells are detected in particular cells like lymphocytes. Five to 90% donor cells set the criteria for mixed chimerism (MC).~Chimerism was not tabulated on day 30." (NCT00448201)
Timeframe: Days 30, 60, and 90

,
Interventionpercentage of patients (Number)
Complete DonorMixed Donor
Day 608218
Day 908713

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Graft-vs-host Disease at 6 Months Post-transplant

"Graft-vs-host disease (GVHD) can be mild, moderate or severe depending on the differences in tissue type between patient and donor. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces~Acute GVHD - Can occur soon after the transplanted cells begin to appear in the recipient. Acute GVHD ranges from mild, moderate or severe, and can be life-threatening if its effects are not controlled.~Extensive chronic GVHD - Usually occurs at about three months post-transplant." (NCT00448201)
Timeframe: 6 Months

Interventionpercentage of participants (Number)
Acute GVHDExtensive Chronic GVHD
All Trial Participants1330

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5-year Disease-free Survival

The length of time post-transplant that the patient survives without any signs or symptoms of that cancer. (NCT00448201)
Timeframe: Year 5

Interventionpercentage of participants (Number)
All Trial Participants31

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Three-year Relapse-free Survival (RFS) Rate at the Maximum Tolerated Dose Identified During Phase I of the Trial (Target AUC 6912)

Relapse is defined as new or increased sites of disease or positive one marrow after a complete response (CR). The RFS was calculated as the percentage of patients who were alive and without relapse at 3 years (NCT00448357)
Timeframe: Three years post-transplant

Interventionpercentage of participants (Number)
Low Busulfan AUC Tertile22
Intermediate Busulfan AUC Tertile39
High Busulfan AUC Tertile43

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Incidence of DNA Chimerism in Patients Between One Month Post Transplant

Deoxyribonucleic acid (DNA) chimerism is a measure identifying the genetic profiles of the transplant recipient and of the donor and then evaluating the extent of mixture in the recipient's blood, bone marrow, or other tissue. (NCT00448357)
Timeframe: 30 days post transplant

InterventionParticipants (Count of Participants)
Whole blood chimerism-AnyWhole blood chimerism->=95% donorT Cell chimerism-AnyT Cell chimerism>=95% donor
Experimental: GVHD Prophylaxis49474630

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Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant

"GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include:~Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body~Blistering, causing the exposed skin surface to flake off in severe cases~Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected~Jaundice, or a yellowing of the skin, which can indicate liver damage~Excessive dryness of the mouth and throat, leading to ulcers~Dryness of the lungs, vagina and other surfaces" (NCT00448357)
Timeframe: 100 days post transplant

,,
InterventionParticipants (Count of Participants)
Acute GVHD grade >=IIAcute GVHD grades III and IVChronic GVHD; intermediate/severe
High Busulfan AUC Tertile1132
Intermediate Busulfan AUC Tertile1046
Low Busulfan AUC Tertile724

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Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen

Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error. (NCT00448357)
Timeframe: Day -15 to Day -11

Interventionpercentage of error (Number)
Dose Level 111.7
Dose Level 24.9
Dose Level 310.2
Dose Level 411.1
Dose Level 515.9

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Overall Survival

Percentage of participants alive at 3 years post transplant (NCT00448357)
Timeframe: Three years post-transplant

Interventionpercentage of participants (Number)
Low Busulfan AUC Tertile (5078)28
Intermediate Busulfan AUC Tertile (6372)39
High Busulfan AUC Tertile (7605)55

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Number of Participants With Dose Limiting Toxicities (DLTs)

Dose limiting toxicity will be defined as any irreversible grade 3 or any grade 4 non-hematologic toxicity that is related to busulfan infusion and not graft vs host disease or late infection after recovery from the initial period of myelosuppression. The maximum tolerated dose (MTD) is defined as the dose with probability of dose limiting toxicity (DLT) of 0.25. The dose of continuous infusion IV busulfan based on blood levels derived from a test dose in conjunction with fludarabine and alemtuzumab plus tacrolimus for GVHD prophylaxis. (NCT00448357)
Timeframe: first 6 weeks or 42 days following stem cell infusion

InterventionDLTs (Number)
Dose Level 11
Dose Level 21
Dose Level 31
Dose Level 42
Dose Level 52

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Risk for Mortality From Infection Before Day 180

Count of participant deaths from infection up to day 180. (NCT00450983)
Timeframe: Up to day 180

InterventionParticipants (Count of Participants)
Treatment0

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Risk for Life-threatening Infections

Count of participants with life-threatening infections (NCT00450983)
Timeframe: Up to day 100

InterventionParticipants (Count of Participants)
Treatment1

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Risk for Graft Failure

Count of participant that had graft failure. (NCT00450983)
Timeframe: Engraftment documented day +20

InterventionParticipants (Count of Participants)
Treatment0

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Risk of Developing Grades III-IV Acute Graft-vs-host Disease (GVHD)

Count of participants with acute GVHD grades III-IV. (NCT00450983)
Timeframe: Up to day 100

InterventionParticipants (Count of Participants)
Treatment0

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Maximum Tolerated Dose (MTD) Oxaliplatin

MTD defined as dose level at which 2/3 or 2/6 participants experience Dose Limiting Toxicity (DLT), where DLTs are any oxaliplatin-related ≥Grade 3 non-hematological toxicity involving a major organ system (brain, heart, kidney, liver, lung) in the National Cancer Institute (NCI) Version 3.0 toxicity scale. (NCT00452374)
Timeframe: From treatment onset to end of each cycle of treatment (every 21 days)

Interventionmg/m^2 (Number)
Oxaliplatin, Fludarabine, Cytarabine + Rituximab25

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Number of Participants With a Complete Response or Partial Response

According to International Workshop Response Criteria for Non-Hodgkin's Lymphomas: Complete remission (CR) defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; and Partial remission (PR) defined as > 50% decrease of clinical symptoms from baseline and recovery from blood counts. (NCT00452374)
Timeframe: Evaluation every 3 cycles of treatment (28 days per cycle), approximately 90 days

InterventionParticipants (Number)
Complete response (CR)Partial response (PR)
Oxaliplatin, Fludarabine, Cytarabine + Rituximab1228

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Incidence of Adverse Events

Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria (NCT00453388)
Timeframe: Up to Day 100

InterventionParticipants (Count of Participants)
Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)3
Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)0

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Incidence of Grades III-IV Acute GVHD

"Number of subjects who developed maximum grade acute graft-vs-host disease~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma with bullous formation and often with desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00453388)
Timeframe: Up to Day 100

InterventionParticipants (Count of Participants)
Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)1
Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)0

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Number of Patients Who Engraft at Each Dose of TBI Used

Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism. (NCT00453388)
Timeframe: Up to Day 200

InterventionParticipants (Count of Participants)
Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation)5
Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation)1

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Length of Survival

(NCT00462332)
Timeframe: At 2 years and a half from study entry

Interventionyears (Mean)
High Risk Patientes1.57
Low Risk Patients1.1

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Number of Patients With Complete Response

"Normal clinical or X-ray examination (lymph nodes, liver, spleen)~No symptoms~Lymphocytes higher or equal to 4.0 per 10^9/L~Neutrophils lower or equal to 1.5 per 10^9/L~Platelets >100 per 10^9/L~Hb >11.0 g/dL~Bone marrow lymphs according to age, lymphocytes <30%, no nodules." (NCT00462332)
Timeframe: At 2 years from study entry

Interventionparticipants (Number)
Low Risk Patients14
High Risk Patients3

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Efficacy of This Therapy 3 Years Post-transplant

Efficacy Assessed as Number of Participants with Overall Survival, Leukemia Progression, Primary Graft Failure and Complete Hematological Response. Primary graft failure is defined as failure to achieve an ANC >/= 0.5 x 10 (9)/L for 3 consecutive days and evidence of donor chimerism by Day +28. Complete hematological response is defined by hemoglobin >/= 120 g/L; or achievement of transfusion independence, with stable Hb > 110 g/L, for RBC transfusion-dependent participants; Spleen not palpable; platelet count 150 x 10 (9)/L; White blood cell 4 x 10 (9)/L to 10 x 10(9)/L. (NCT00475020)
Timeframe: Up to 3 years post-transplant

InterventionParticipants (Count of Participants)
Overall survival at 3 yearsLeukemia progressionPrimary graft failuresComplete hematological remission
Participants With Myelofibrosis and Myelodysplastic Syndrome2527044

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Rate of Non-relapse Mortality at 100 Days Post-transplant

To evaluate the safety of Fludarabine/Busulfan as conditioned regimen for allogeneic stem cell transplantation in patients with myelofibrosis/myelodysplastic syndrome at 100 days post-transplant (NCT00475020)
Timeframe: Non-relapse mortality at 100 days post-transplant

InterventionParticipants (Count of Participants)
InfectionsOrgan FailuresSudden death: likely due to ischemic cardiac event
Participants With Myelofibrosis and Myelodysplastic Syndrome121

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Number of Patients With Platelet Engraftment

Number of patients with a platelet count >5 x 10^10 cells/liter for 3 consecutive measurements. (NCT00478244)
Timeframe: Day 180 Post Transplant

Interventionparticipants (Number)
Evaluable Patients5

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Number of Patients With Chronic Graft-Versus-Host Disease (cGVHD)

Number of patients with cGVHD; a severe long-term complication created by infusion of donor cells into a foreign host. (NCT00478244)
Timeframe: Day 365 Post Transplant

Interventionparticipants (Number)
Evaluable Patients0

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Number of Patients With >70% Donor Chimerism

Number of patients with donor chimerism - percentage of donor cells in the patient via the peripheral blood or bone marrow. (NCT00478244)
Timeframe: Days 21, 100, 180, 365 and 730 Post Transplant

Interventionparticipants (Number)
Day 21Day 100Day 180Day 365Day 730
Evaluable Patients65555

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Overall Survival

Survival is defined as the number of patients that were alive post transplant. (NCT00478244)
Timeframe: 1 year and 2 years Post Transplant

Interventionparticipants (Number)
1 Year Post Transplant2 Years Post Transplant
Evaluable Patients55

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Number of Patients With Detectable Collagen Type VII

Number of patients with epidermolysis bullosa who had collagen type VII. Type VII collagen defects cause recessive dystrophic epidermolysis bullosa (RDEB), a blistering skin disorder often accompanied by epidermal cancers. (NCT00478244)
Timeframe: Day 100 Post Transplant

Interventionparticipants (Number)
Evaluable Patients5

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Number of Patients With Donor Derived Cells in Skin

Number of patients who had donor skin chimerism - donor cells in the patient's epidermis (a state in bone marrow transplantation in which bone marrow and host cells exist compatibly without signs of graft-versus-host rejection disease). (NCT00478244)
Timeframe: Day 90 Post Transplant

Interventionparticipants (Number)
Evaluable Patients6

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Number of Patients With Neutrophil Engraftment

Number of patients with an absolute neutrophil count >5 x 10^8 cells/liter for 3 consecutive days. (NCT00478244)
Timeframe: Day 42 Post Transplant

Interventionparticipants (Number)
Evaluable Patients6

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Number of Patients With Resistance to Blister Formation

Resistance to Blister Formation demonstrated by response to negative pressure. (NCT00478244)
Timeframe: Month 1 through Month 24 Inclusive

Interventionparticipants (Number)
Evaluable Patients2

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Number of Patients With Acute Graft-Versus-Host Disease (GVHD)

Number of patients with GVHD. Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. (NCT00478244)
Timeframe: Day 100 Post Transplant

Interventionparticipants (Number)
Evaluable Patients1

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Number of Participants With Objective Response

Objective response: Complete Response/Remission (CR) defined as a bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/Liters or more and platelet count of 100*10^9/Liters or more; Complete Response with Platelets/remission without platelet recovery (CRp) defined as a complete response except for a platelet less than 100*10^9/Liters and transfusion independent; and Partial Response/Remission defined as peripheral blood count recovery as for CR with decrease in marrow blasts >/= 50% and not more than 6-25% abnormal cells in the marrow. (NCT00480987)
Timeframe: After 2 months

InterventionParticipants (Number)
Complete responseComplete response with plateletsPartial response
Oxaliplatin + Cytarabine + Fludarabine320

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Participants' With mCR Response to Post Transplant DLI

Number of participants with response of molecular complete remission (mCR) to DLI as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests. (NCT00499889)
Timeframe: 1 year

InterventionParticipants (Number)
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin4

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Number of Participants in Complete Molecular Remission at 1 Year

Participants at 1 year in molecular remission, post transplant, post imatinib mesylate and donor lymphocyte infusion (DLI). Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests (this test is most commonly used in clinical trials). (NCT00499889)
Timeframe: Baseline to 1 year

Interventionparticipants (Number)
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin21

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Participants' With mCR Response to Post Transplant Imatinib Mesylate Therapy

Number of participants with response of molecular complete remission (mCR) to Imatinib Mesylate therapy as treatment for residual disease after transplant. Molecular remission is a complete remission with no evidence of disease in the blood cells and/or bone marrow using sensitive polymerase chain reaction (PCR) tests. (NCT00499889)
Timeframe: 1 Year

InterventionParticipants (Number)
Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin10

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Number of Participants With Successful Engraftment

Successful Engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Failure to engraft by day +30 considered primary engraftment failure. Study period one week prior to transplant through post Day 28. (NCT00502905)
Timeframe: Study period one week prior to transplant through post Day 28

Interventionparticipants (Number)
Busulfan + Fludarabine192

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Number of Participants With Successful Engraftment at Day 100

(NCT00505895)
Timeframe: Day 100

Interventionparticipants (Number)
Fludarabine + Melphalan + Stem Cell Infusion27
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion23

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Acute Grade II-IV Graft Versus Host Disease (GVHD)

Effects of Rituximab as measured by percentage of participants with Acute and Chronic Graft Versus Host Disease (GVHD) incidences after allogeneic transplantation. GVHD occurring anytime after day 90 post transplant was considered chronic GVHD; otherwise it was considered acute GVHD. Acute GVHD status defined as GVHD with maximum grade ≥2. Clinical grading of Acute GVHD (Thomas et al., New England Journal of Medicine (NEJM), 229:895, 1975): Grade 1 to 4. (NCT00505895)
Timeframe: GVHD grading weekly during first 100 days; Annual examinations for nine year study period

,
Interventionpercentage of participants (Number)
Acute GVHDChronic GVHD
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion2148
Fludarabine + Melphalan + Stem Cell Infusion2229

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Participant Progression Free Survival at 2 Years

Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant. (NCT00505921)
Timeframe: 2 years

Interventionparticipants (Number)
Campath-1H15

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Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)

Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( > 90% to < 100%); only traces of disease remains; 2) Significant improvement ( > 75% to < 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( > 50% to < 75%); 4) Some improvement ( > 25% to < 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by > 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one. (NCT00506129)
Timeframe: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.

Interventionparticipants (Number)
Complete Response (CR) Converted Post TransplantCR Prior to TransplantPartial Response (PR)Stable Disease (SD)Progressive Disease (PD)
Fludarabine + Melphalan With PBPC1960016

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Average Overall Survival (OS) Length

OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days. (NCT00506129)
Timeframe: Baseline to disease progression, followed up to 5 years post transplant

InterventionDays (Mean)
Fludarabine + Melphalan With PBPC1207

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Maximum Tolerated Dose (MTD)

"Continual reassessment method (four times a day) used to determine an MTD, with a target toxicity probability of 20%, where toxicity is defined as grade 3 or 4 conventional toxicity [National Cancer Institute Common Toxicity Criteria (NCI-CTC)]. Participant evaluation in a cohort with each modality is 30 days." (NCT00506857)
Timeframe: 1 month

Interventionmg/kg (Number)
Busulfan + Fludarabine11.2

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Number of Participants With Graft Versus Host Disease (GVHD)

Tacrolimus and Methotrexate used for acute graft versus host disease (aGVHD) prophylaxis, clinical grading AGVHD criteria (Days 1-100): Grade 1: + to ++ skin rash; no gut involvement; no decrease in clinical performance status; Grade 2: + to +++ skin rash; + gut involvement and/or + liver involvement; mild decrease in performance status; Grade 3: ++ to +++ skin rash; ++ to +++ gut involvement and/or ++ to ++++ liver involvement; marked decrease in performance status; Grade 4: Similar to Grade 3 with ++ to ++++ organ involvement and extreme decrease in performance status. (NCT00506857)
Timeframe: 5 years

InterventionParticipants (Number)
Grade 2Grade 3-4
Tacrolimus + Methotrexate188

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Toxicity

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00509496)
Timeframe: 6 years

InterventionParticipants (Number)
Anti-gp100:154-162 TCR PBL + HD IL-219
Anti-gp100:154-162 TCR TIL + HD IL-22

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Clinical Tumor Regression.

Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD)is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00509496)
Timeframe: 20 months

,
InterventionParticipants (Number)
Complete ResponsePartial ResponseProgressive DiseaseStable Disease
Anti-gp100:154-162 TCR PBL + HD IL-212160
Anti-gp100:154-162 TCR TIL + HD IL-20110

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Toxicity

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT00513604)
Timeframe: 5 years

InterventionParticipants (Number)
Cohort 1 - NMA, TIL, Aldesleukin24
Cohort 2 - NMA, CD4+ TIL, Aldesleukin39
Cohort 3 - NMA, Total Body Irradiation23
Cohort 4 - NMA, Young TIL, Aldesleukin34
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin35

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Clinical Response

Clinical response is defined as complete response (CR)- a disappearance of all target lesions, partial response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD)- at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00513604)
Timeframe: every 1-3 months until disease progression. Total length of time -8/7/2007 to 9/27/2012

,,,,
InterventionParticipants (Number)
Complete ResponsePartial ResponseProgressionStable DiseaseNot evaluable - cell product did not growNot evaluable-toxicities re:disease/deathNot evaluable - Patient died of sepsis
Cohort 1 - NMA, TIL, Aldesleukin13200200
Cohort 2 - NMA, CD4+ TIL, Aldesleukin318160020
Cohort 3 - NMA, Total Body Irradiation37120101
Cohort 4 - NMA, Young TIL, Aldesleukin210211000
Cohort 5 - NMA, CD4+TIL, HD Aldesleukin34244000

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Overall Survival in Low Risk Patients

"Overall survival in low risk patients (registration to first treatment or death)>~• Events were defined as death from any cause. Low risk Patients who were alive were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months

Interventionmonths (Median)
Arm C: Low Risk Observation + Later Treatment58.1

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Disease-Free Survival in High Risk Patients

"Kaplan-Meier analysis was conducted to estimate disease free survival defined as:>~Arm A: Time from randomization until Second Treatment (first relapse) or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up.>~Arm B: Time from randomization until First Treatment (first relapse) or death whichever comes first. Events were defined as the start of first treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months

Interventionmonths (Median)
Arm A: High Risk Early Intervention62.7
Arm B: High Risk Observation + Later Treatment39.2

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Overall Survival (OS) for High Risk Patients

Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to death from any cause. Estimates were not stratified. Patients who did not experience this primary outcome had their survival times censored at their last follow-up. (NCT00513747)
Timeframe: Up to 72 months

Interventionmonths (Median)
Arm A: High Risk Early InterventionNA
Arm B: High Risk Observation + Later TreatmentNA

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Time to First Treatment Survival in Low Risk Patients

"Time to First Treatment Survival in low risk patients (registration to first treatment or death)>~• Events were defined as the start of first treatment or death from any cause. Patients who didn't receive their first treatment were censored at their last known follow-up." (NCT00513747)
Timeframe: Up to 72 months

Interventionmonths (Median)
Arm C: Low Risk Observation + Later Treatment58.1

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Time to Second Treatment in High Risk Patients

Kaplan-Meier analysis was conducted to estimate the distribution of time from randomization to second treatment or death whichever comes first. Events were defined as the start of second treatment or death. Patients who had not experienced one of these defined events of interest were censored at their last known follow-up. (NCT00513747)
Timeframe: Up to 72 months

Interventionmonths (Median)
Arm A: High Risk Early Intervention62.7
Arm B: High Risk Observation + Later Treatment56.3

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Overall Participant Response

Overall Response: Complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. National Cancer Institute - Working Group (NCI-WG) response criteria. CR defined as zero nodes, Liver/spleen not palpable, zero symptoms, polymorphonuclear leukocyte (PMN)>1,500/uL, Platelets >100,000uL, Hemoglobin (untransfused) >11.0g/dL, Lymphocytes <4,000/uL and Bone Marrow Aspirate biopsy <30% lymphocytes with no lymphocyte infiltrate; PR defined as nodes >/= 50% decrease,Liver/spleen >/= 50% decrease, symptoms not applicable, PMN >1,500/uL or >50% improvement from baseline, Platelets 100,000uL or >/=50% decrease improvement from baseline, Hemoglobin (untransfused) >11.0g/dL or >50% improvement from baseline, Lymphocytes >50% decrease and Bone Marrow Aspirate biopsy Not Applicable for PR; with nPR defined same as PR but with <30% lymphocytes with residual disease on biopsy. (NCT00525603)
Timeframe: Evaluated after 3 courses of 4 week therapy (12 weeks)

InterventionParticipants (Number)
Complete remission (CR)Nodular partial remission (nPR)Partial remission (PR)
CFAR44110

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Overall Survival at 100 Days Post Transplant (Number of Surviving Participants)

Overall Survival defined as the number of participants living at day 100 following non-myeloablative allogeneic stem cell transplantation using rituximab, cyclophosphamide, fludarabine as a preparative regimen for participants with advanced or recurrent mantle cell lymphoma. (NCT00525876)
Timeframe: 100 days post transplant

Interventionparticipants (Number)
Matched Sibling Transplant16
Allo MUD & MM19

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Neutrophil Engraftment - The Days Till ANC Recovery

The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment. (NCT00544115)
Timeframe: Up to 180 days post transplant

Interventiondays (Median)
Regimen I17
Regimen II16
Regimen III15
Regimen IV14
Regimen V18
Regimen VI16

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Two-year Overall Survival

Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented. (NCT00544115)
Timeframe: Up to 2 years post transplant

Interventionpercentage of survival probability (Number)
Regimen I58
Regimen II50
Regimen III54
Regimen IV50
Regimen V38
Regimen VI50

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Overall Survival on Day 180 Days Post-transplant

Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 180 days after transplant and Kaplan-Meier survival analysis was used to generate the Overall Survival estimate at 180 days. (NCT00544466)
Timeframe: Up to 180 days post-transplant

InterventionPercent Probability (Number)
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)81

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Number of Grade 3 and Above Toxicities of Helical Tomotherapy (HT) in Combination With Fludarabine and Melphalan Followed by Allogeneic Stem Cell Transplantation.

Toxicities (adverse events) were evaluated using the modified Bearman Scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00544466)
Timeframe: 100 days post treatment

Interventionevents (Number)
Treatment (Enzyme Inhibitor, Radiation Therapy, Transplant)793

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Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)

Number of surviving patients at Day 180 post-transplant divided by number of patients undergone transplantation. (NCT00547196)
Timeframe: From transplant up to Day 180 post-transplant

Interventionpercentage of surviving patients (Number)
Regimen I (FTBI, Cyclophosphamide, Fludarabine)60
Regimen III (TBI, Cyclophosphamide, Fludarabine)100
Regimen IV (Fludarabine, Melphalan)50

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Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)

Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation. (NCT00547196)
Timeframe: From transplant to Day 100 post-transplant

Interventionpercentage of surviving patients (Number)
Regimen I (FTBI, Cyclophosphamide, Fludarabine)100
Regimen III (TBI, Cyclophosphamide, Fludarabine)100
Regimen IV (Fludarabine, Melphalan)100

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Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant

Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant. (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)8

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Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant

Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)16

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Disease Response by 1 Year Post Transplant

Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence) (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)15

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Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant

Number of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant. (NCT00553098)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)21

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Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism

The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism. (NCT00553098)
Timeframe: At 1 year post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)13

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Overall Survival

Number of patients alive at 1 year (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)19

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Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD

Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)6

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Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD

Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)12

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Number of Patients Diagnosed With Chronic GVHD

Number of patients diagnosed with chronic GVHD within 1 year post transplant (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)8

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Number of Patients Diagnosed With Acute GVHD

Number of patients diagnosed with acute GVHD by Day 100 post transplant (NCT00553098)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)18

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Immune Reconstitution by 1 Year Post Transplant

Number of patients with normal range CD3 at 1 year post transplant (NCT00553098)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Low Dose Radiation)7

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Progression-free Survival at 1 Year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year

Interventionproportion of progression-free pts (Number)
High-Risk or Relapsed Hodgkin Lymphoma33.3

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Overall Survival

(NCT00574496)
Timeframe: up to 8 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma70.3

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Disease Relapse or Progression as Measured by CT Scan or PET

(NCT00574496)
Timeframe: 3 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma34.3

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Relapse/Progression Rate at Two Years

The primary endpoint was 2-year cumulative incidence of relapse/progression (RP), defined as time from alloHCT to disease recurrence or progression. Cumulative incidences for RP was generated in a competing-risk setting, given that death events were competing events. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years

Interventionpercentage of cumulative incidence (Number)
0.4 mCi 90Y-Ibritumomab Tiuxetan20

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Progression-free Survival at Two Years

Progression-free survival (PFS) was measured from initial treatment to disease progression or death from any cause, whichever came first. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years

Interventionpercentage of survival probability (Number)
0.4 mCi 90Y-Ibritumomab Tiuxetan61

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Overall Survival at Two Years

Overall survival (OS) was measured from initial treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. (NCT00577278)
Timeframe: From the initial treatment to the last disease assessment, up to two years

Interventionpercentage of survival probability (Number)
0.4 mCi 90Y-Ibritumomab Tiuxetan63

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Death From GVHD

To establish the early transplant-related severe morbidity and mortality and 3-the incidence and severity of GvHD. (NCT00582933)
Timeframe: 2 years

Interventionparticipants (Number)
Transplant Patients4

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Two-Year Disease-free Survival of Study Participants Who Completed the Study Regimen

"Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following:~1, Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis.~2. Normalization of blood counts (no basts, platelets >100,000/mm3, granulocytes >1,500/mm3) 3. No extramedullary disease." (NCT00589316)
Timeframe: 2 years post-transplant

InterventionParticipants (Count of Participants)
Dose Level 1: 12 Gy Iodine-131 + BC8 Monoclonal Antibody0
Dose Level 2: 14 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 3: 16 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 4: 18 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 5: 20 Gy Iodine-131 + BC8 Monoclonal Antibody1
Dose Level 6: 22 Gy Iodine-131 + BC8 Monoclonal Antibody0
Dose Level 7: 24 Gy Iodine-131 + BC8 Monoclonal Antibody0
Dose Level 8: 26 Gy Iodine-131 + BC8 Monoclonal Antibody1

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Time to Absolute Neutrophil Count Recovery (Engraftment)

Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days (NCT00589563)
Timeframe: Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT

InterventionDays (Median)
All Patients14.5

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Incidence of Disease Relapse/Progression at 2 Years Post HSCT

Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.

InterventionPercentage of patients who relapsed (Number)
All Patients12.5

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Event Free Survival at Two Years Post HSCT

Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event. (NCT00589563)
Timeframe: 2 year point estimate was provided.

InterventionPercentage of patients with an event (Number)
All Patients61.3

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Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100

Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment. (NCT00589563)
Timeframe: 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)

InterventionPercentage of patients developing aGVHD (Number)
All Patients37.3

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Cumulative Incidence of Chronic GVHD

Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.

InterventionPercentage of patients developing cGVHD (Number)
All Patients62.5

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Non-relapse Mortality at 100 Days Post HSCT

Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment. (NCT00589563)
Timeframe: 100 day point estimate was provided

InterventionPercentage of patients with a NRM (Number)
All Patients9.4

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Overall Survival at Two Years Post HSCT

Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date. (NCT00589563)
Timeframe: 2 year point estimate was provided.

InterventionPercentage of patients who died (Number)
All Patients65.6

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Non-relapse Mortality at Two Years Post HSCT

Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment. (NCT00589563)
Timeframe: 2 year point estimate was provided.

InterventionPercentage of patients with a NRM (Number)
All Patients15.6

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Occurrence of Thrombotic Microangiopathy

Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA. (NCT00589563)
Timeframe: Median Follow Up: 28 Months (Range: 1-49 months)

Interventionparticipants (Number)
All Patients7

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Severity of Chronic GVHD

All Patients were considered for the evaluation of chronic GVHD severity. (NCT00589563)
Timeframe: Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT

Interventionparticipants (Number)
No Chronic GVHDYes- LimitedYes - ExtensiveNo- Inevaluable (graft failure/died
All Patients44177

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Severity of Acute GVHD

All patients were considered for the evaluation of the severity of acute GVHD. (NCT00589563)
Timeframe: 100 Days Post HSCT

Interventionparticipants (Number)
No Acute GVHDYes - Grade IYes- Grade IIYes- Grade IIIYes - Grade IVNo- Inevaluable (graft failures)
All Patients999104

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Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation

Participants were monitored throughout the trial (median of 28 months) for various infections/complications. (NCT00589563)
Timeframe: Median Follow Up: 28 months (Range: 1-49 months)

Interventionparticipants (Number)
Neither CMV or EBVCMV reactivation onlyEBV onlyBoth CMV and EBV
All Patients16934

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Time to Platelet Count Recovery (Engraftment)

Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days. (NCT00589563)
Timeframe: Patients were evaluated until platelet recovery, a median of 14 days

InterventionDays (Median)
All Patients14

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Occurence of Sinusoidal Obstructive Syndrome (SOS)

Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS. (NCT00589563)
Timeframe: Median Follow Up: 28 Months (Range: 1-49 Months)

Interventionparticipants (Number)
All Patients1

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Overall Response Rates in Patients With Del(11q22.3)

Percentage of del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. (NCT00602459)
Timeframe: Up to 15 years

Interventionpercentage of participants (Number)
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)59
Arm D (Rituximab, Fludarabine, Cyclophosphamide, Lenalidomide)74

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Overall Response Rate in Patients Without Del(11q22.3)

Percentage of non-del(11q22.3) participants with a complete response (CR) or partial response (PR). CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus >= 1 of the following: >= 1500/uL polymorphonuclear leukocytes, > 100,000/uL platelets, > 11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions. (NCT00602459)
Timeframe: Up to 15 years

Interventionpercentage of participants (Number)
Arm A (Rituximab, Fludarabine Phosphate)75
Arm B (Rituximab, Fludarabine Phosphate, Lenalidomide)69
Arm C (Rituximab, Fludarabine Phosphate, Cyclophosphamide)71

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PFS Rate of Patients With Del(11q22.3)

Proportion of del (11q22.3) participants who were alive and progression free at 2 years. (NCT00602459)
Timeframe: 2 years

Interventionproportion of participants (Number)
Arm C2, FCR in Del(11q22.3)0.56
Arm D, FCR+L in Del(11q22.3)0.65

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Time-to-progression in Patients With Del(11q22.3)

Time to progression (TTP) in del(11q22.3) participants was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. (NCT00602459)
Timeframe: Up to 15 years

Interventionmonths (Median)
Arm C2, FCR in Del(11q22.3)35.5
Arm D, FCR+L in Del(11q22.3)44.6

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Time-to-progression in Patients Without Del(11q22.3)

Time to progression (TTP) was defined as the registration date to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progressive disease (PD) required at least one of the following: >= 50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes, >= 50% increase in the product of at least two lymphnodes, >= 50% increase in the enlargement of the liver and/or spleen. (NCT00602459)
Timeframe: Up to 15 years

Interventionmonths (Median)
Arm A, FR in Non-del(11q22.3)43.5
Arm B, FR+L in Non-del(11q22.3)66.0
Arm C1, FCR in Non-del(11q22.3)78.0

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2-Year Progression Free Survival (PFS) Rate

Proportion of participants who were alive and progression free at 2 years. (NCT00602459)
Timeframe: 2 years

Interventionproportion of participants (Number)
Arm A, FR in Non-del(11q22.3)0.64
Arm B, FR+L in Non-del(11q22.3)0.71
Arm C1, FCR in Non-del(11q22.3)0.74

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Percentage of Participants With Chronic GVHD in the 2 Groups

Comparaison of the number of Participants with chronic GVHD in the 2 groups (NCT00603954)
Timeframe: 2 years after HCT

Interventionpercentage of participants (Number)
Flu-TBI40.8
TLI-ATG18.8

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Percentage of Relapse Rate in the 2 Groups

(NCT00603954)
Timeframe: 1 year after HCT

Interventionpercentage of Relapse (Number)
Flu-TBI22
TLI-ATG50

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Percentage of 4-year Overall Survival in the 2 Groups

(NCT00603954)
Timeframe: 4 year after HCT

Interventionpercentage of participants (Number)
Flu-TBI53
TLI-ATG54

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Quality and Timing of Immunologic Reconstitution: Concentration of ATG Levels

Analyses of ATG levels in order to assess the immune system recuperation (NCT00603954)
Timeframe: Day 0, Day 3 and Day 10

Interventionmg/L (Median)
Median ATG serum levels at day 0Median ATG serum levels at day 3Median ATG serum levels at day 10
TLI-ATG42.20.95

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Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups

"Percentage of participants with aGVHD according grades:~Grade I: rash skin < 25 % area; bilirubin: 20-30 mg/ml; diarrhea: 500-1000 ml/day Grade II: rash skin 25-50 % area; bilirubin: 30-60 mg/ml; diarrhea: 10000-1500 ml/day Grade III:rash skin > 50 % area; bilirubin: 60-150 mg/ml; diarrhea: >1500 ml/day Grade IV: erythroderma; bilirubin: > 150 mg/ml; diarrhea: >2000 ml/day~Grade IV is the worst grade Patients given a second allogeneic HCT were censured for GVHD analyses." (NCT00603954)
Timeframe: 180 days after HCT

Interventionpercentage of participants with aGVHD (Number)
Flu-TBI12.2
TLI-ATG8.9

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Incidences of Bacterial, Fungal and Viral Infections in the 2 Groups.

(NCT00603954)
Timeframe: D100 after HCT

,
Interventionparticipants (Number)
Bacterial infectionFungal infectionCMV reactivation
Flu-TBI19315
TLI-ATG25721

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Number of Participants With Graft Rejection as Defined by Whole Blood and T Cell Chimerism

graft rejection are reported in outcome measure data table (defined as ≤ 5% donor chimerism in T cells, total white blood cells and/or total bone marrow cells). (NCT00603954)
Timeframe: 1 year after HCT

Interventionparticipants (Number)
Flu-TBI3
TLI-ATG4

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Percentage of 4-year Progression Free Survival in the 2 Groups

(NCT00603954)
Timeframe: 4 year after HCT

Interventionpercentage of participants (Number)
Flu-TBI54
TLI-ATG37

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Percentage of 5-year Overall Survival in the 2 Groups

(NCT00603954)
Timeframe: 5 year after HCT

Interventionpercentage of participants (Number)
Flu-TBI53
TLI-ATG55

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Percentage of 5-year Progression Free Survival in the 2 Groups

(NCT00603954)
Timeframe: 5 year after HCT

Interventionpercentage of participants (Number)
Flu-TBI50
TLI-ATG37

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Percentage of Non Relapse Mortality in the 2 Groups

(NCT00603954)
Timeframe: 1 year after HCT

Interventionpercentage of participants (Number)
Flu-TBI24
TLI-ATG13

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Number of Participants With Acute Graft-versus-host Disease (GVHD)

Participants who exhibit acute GVHD. (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning1
Reduced-intensity Conditioning0

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Overall Survival

Overall survival at 1 year (NCT00608517)
Timeframe: 1 year

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning3
Reduced-intensity Conditioning1

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Number of Subjects With All-cause Mortality

Death from any cause at 100 days (NCT00608517)
Timeframe: at 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants With Sustained Donor Engraftment of Umbilical Cord Blood Stem Cells

Recovery of the neutrophil portion of white blood cells and showing complete donor cells. (NCT00608517)
Timeframe: 42 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning1

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Number of Participants With Chronic Graft Versus Host Disease (GVHD)

As opposed to acute GVHD, which is characterized by rash, cholestasis, and enteritis, chronic GVHD is characterized by nausea, anorexia, ocular and oral sicca, and other organ involvement (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants With 100-day Non-relapse Mortality

Evaluate the safety (as determined by the day 100 non-relapse mortality) and feasibility of single or double umbilical cord blood (UCB)stem cell transplant (SCT) in adult or pediatric patients with hematologic malignancies receiving graft-versus-host disease (GVHD) prophylaxis with tacrolimus and mycophenolate mofetil (MMF). (NCT00608517)
Timeframe: 100 days

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning1
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants Who Relapsed at 1 Year

(NCT00608517)
Timeframe: 1 year

Interventionparticipants (Number)
Pediatric Myeloablative Conditioning0
Adult Myeloablative Conditioning0
Reduced-intensity Conditioning0

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00610311)
Timeframe: 18.5 months

InterventionParticipants (Number)
ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-23

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Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)

Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module. (NCT00610311)
Timeframe: 4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met

InterventionParticipants (Number)
Partial response (PR)Complete response (CR)
ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-210

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Number of Participants With Metastatic Melanoma Who Develop Clinical Tumor Regression (CR or PR)

Clinical tumor response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is a 30% decrease in lesions taking as reference the baseline sum longest diameter (LD). For details about the RECIST criteria see the protocol link module. (NCT00612222)
Timeframe: 4-6 weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met

InterventionParticipants (Number)
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-20

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00612222)
Timeframe: 15 months

InterventionParticipants (Number)
ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-24

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Neutrophil Engraftment

Incidence of neutrophil recovery and donor chimerism at Day 100. (NCT00618540)
Timeframe: Day 100

Interventionparticipants (Number)
Alemtuzumab Conditioning1

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Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD)

The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. (NCT00618540)
Timeframe: Day 100 and Month 6

Interventionparticipants (Number)
Alemtuzumab Conditioning0

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Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD)

The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive <21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. (NCT00618540)
Timeframe: Day 100 and Month 6

Interventionparticipants (Number)
Alemtuzumab Conditioning1

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Incidence of Chronic GVHD

Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving > 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up. (NCT00618540)
Timeframe: Day 100 and Month 6

Interventionparticipants (Number)
Alemtuzumab Conditioning0

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Overall Survival

Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact. (NCT00618540)
Timeframe: Year 1, Year 3

Interventionparticipants (Number)
Alemtuzumab Conditioning0

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Disease-free Survival at 12 Months Post Transplantation

"This outcome is defined as survival with resolution of LCH at 12 months post transplant.~Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events.~Those who survive with resolution of disease are censored at the date of last contact." (NCT00618540)
Timeframe: Year 1

Interventionparticipants (Number)
Alemtuzumab Conditioning0

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Platelet Engraftment

Incidence of platelet recovery and donor chimerism at Day 100. (NCT00618540)
Timeframe: Day 100

Interventionparticipants (Number)
Alemtuzumab0

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Number of Patients Alive 24 Months Post Day 100 Transplant

Patients will be followed for survival for 24 months post day 100 transplant. (NCT00619645)
Timeframe: 24 months post day 100 transplant

InterventionParticipants (Count of Participants)
RIST for Heme Malignancies3

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Quality of Life as Assessed by the Medical Outcome Short Form (36) Health Survey Instrument (SF-36)

The Medical Outcome Short Form (36) Health Survey instrument (SF-36) is a general assessment of health quality of life with eight components: physical functioning, role limitations due to physical health, pain index, general health perceptions, vitality, social functioning, role limitations due to emotional problems and Mental Health Index. Each domain is positively scored, indicating that higher scores are associated with positive outcome. (NCT00622895)
Timeframe: Up to 5 years

Interventionunits on a scale (Number)
SF-36 pretransplant overall scorepretransplant limitations due to physical healthpretransplant limitations due to emotional health
Treatment: Allogeneic HCT After Reduced Intensity Conditioning49.35050

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Incidence and Severity of Graft-versus-host Disease (GVHD)

The grading of acute and chronic GVHD will follow previously published guidelines and according to institutional standard of practice but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and SSc involve the skin and the gastrointestinal tract, all diagnostic biopsies of these organs will be centrally reviewed by a study pathologist. (NCT00622895)
Timeframe: Up to 5 years post-transplant

Interventionunits on a scale (Number)
acute GVHD severity maximum gradechronic GVHD maximum grade
Treatment: Allogeneic HCT After Reduced Intensity Conditioning22

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Quality of Life as Assessed by the Modified Scleroderma Health Assessment Questionnaire (SHAQ)

The questionnaire includes measure of quality of life and measure of the scale of skin tightness, activity level and function specifically designed for patients with systemic sclerosis (NCT00622895)
Timeframe: Up to 5 years

Interventionunits on a scale (Number)
pre-transplant SHAQ5 year post transplantpre-transplant Raynaud symptoms5 year post transplant Raynaud symptomspre-transplant Finger ulcer symptoms5 year post-transplant Finger ulcer symptomspre-transplant Overall health symptoms5 year post-transplant overall health symptoms
Treatment: Allogeneic HCT After Reduced Intensity Conditioning1.1250.12530.5302.50.2

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Skin Score

The skin score measure is a scale: the name of the scale is the modified Rodnan skin score (mRSS). Total score of mRSS is from 0 to 51. Higher values represents worse skin score. Highest value is 51, represents very hidebound tight thick skin. Lowest value is 0, represent normal skin, no tightness. (NCT00622895)
Timeframe: Up to 5 years post-transplant

Interventionunits on a scale (mRSS) (Number)
Pre-transplant (baseline) skin score5 year post-transplant skin score
Treatment: Allogeneic HCT After Reduced Intensity Conditioning174

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Event-free Survival (EFS)

The events will be defined as any one of the following: death; respiratory failure; renal failure, as defined by chronic dialysis > or = 6 months or kidney transplantation; occurrence of cardiomyopathy, confirmed by clinical CHF (New York Class III or IV) or LVEF < 30% by echocardiogram, sustained for at least 3 months despite therapy; organ dysfunction specific events must be documented on at least two occasions > or = 3 months apart, or sustained for a 3-month period (documented from the first occurrence). (NCT00622895)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Treatment: Allogeneic HCT After Reduced Intensity Conditioning1

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EFS

event-free survival after umbilical cord blood transplant (NCT00622895)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
Treatment: Allogeneic UCB After Reduced Intensity Conditioning1

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Incidence of Graft Rejection

Engraftment is defined as achieving > 5% donor peripheral blood T cell chimerism by Day 56 after HCT. Primary graft failure is defined as a donor peripheral blood T cell chimerism peak of < 5% by Day 56 post-HCT. Methodological requirements for chimerism are as defined by institutional standard of practice. Secondary Graft Failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood T cell chimerism < 5% as demonstrated by a chimerism assay (NCT00622895)
Timeframe: Up to day +56

InterventionParticipants (Count of Participants)
Treatment: Allogeneic HCT After Reduced Intensity Conditioning0

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Overall Survival

Event is defined as death due to any cause. (NCT00622895)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment: Allogeneic HCT After Reduced Intensity Conditioning1

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The Percent of Participants With Definite and Probable Viral, Fungal, and Bacterial Infections

The percent of participants with definite and probable viral, fungal, and bacterial infections after transplant (NCT00622895)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment: Allogeneic HCT After Reduced Intensity Conditioning2

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Number of Patients Exhibiting Natural Killer Cell Expansion

Successful natural killer (NK) cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl 14 days after infusion with <5% donor T and B cells in the mononuclear population. (NCT00625729)
Timeframe: Day 14

InterventionParticipants (Number)
Patients Treated With Natural Killer Cells0

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Number of Patients With Interleukin-15 Production and NK Cell Expansion

Correlation of interleukin-15 production at day 0 with natural killer (NK) cells expansion (NCT00625729)
Timeframe: Day 0

InterventionParticipants (Number)
Patients Treated With Natural Killer Cells0

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Number of Patients With Adequate Natural Killer Cells Infused

Incidence of donor products that met release criteria in accordance with FDA regulations (Lot Release Criteria for allogeneic, interleukin-2 (IL-2) activated natural killer (NK) cell products (BB-IND 8847) and the NK cell numbers infused (donor NK cell dose 1.5-8.0 x 10^7/kg). (NCT00625729)
Timeframe: Day 0

InterventionParticipants (Number)
Patients Treated With Natural Killer Cells6

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Number of Patients Whose Disease Progressed After Treatment

Includes patients (with non-Hodgkin leukemia or chronic lymphocytic leukemia) whose disease progressed after treatment. (NCT00625729)
Timeframe: 6 Months

InterventionParticipants (Number)
Responder Patients2

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Number of Patients With Overall Survival

Number of patients alive at 6 months after treatment. (NCT00625729)
Timeframe: 6 Months

InterventionParticipants (Number)
Patients Treated With Natural Killer Cells3

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Number of Patients With Overall Response

Overall response (complete remission plus partial remission) rate at 3 months, as defined by International Working Group for non-Hodgkin lymphoma and NCI Working Group guidelines for chronic lymphocytic leukemia (NCT00625729)
Timeframe: 3 Months

InterventionParticipants (Number)
Patients Treated With Natural Killer Cells4

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Median Number of Days to Progression

Median number of days from first date of treatment to date of disease progression (appearance of new metastatic lesions or objective tumor progression). Defined by computated tomography (CT) imaging based on Response Evaluation Criteria In Solid Tumors (RECIST): Progressive Disease (PD) > or = 20% increase in sum of all target or any new lesions. (NCT00652899)
Timeframe: From date of first treatment to disease progression

InterventionDays (Median)
No Total Body Irradiation107
Total Body Irradiation90

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Number of Patients Per Disease Response

Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Complete Response (CR)-Disappearance of all target lesions (TL); Partial Response (PR)-< or = 30% decrease in the sum of the longest diameter (LD) of TL, reference baseline sum LD; Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference the smallest sum LD since the treatment started; Progressive Disease (PD)- < or = 20% increase in the sum of the LD of TL, reference the smallest sum LD recorded since treatment started or appearance of < or = 1 new lesion. (NCT00652899)
Timeframe: 1 Month After Natural Killer Cell Infusion (Day 30)

,
InterventionPatients (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
No Total Body Irradiation0241
Total Body Irradiation0140

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Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product

Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion. (NCT00652899)
Timeframe: Day 12-14

InterventionPatients (Number)
Ovarian/Fallopian Tube/Peritoneal Cancer Patients0

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Median Overall Survival Number of Days Patients Alive After Treatment

Median number of days patients alive from date of treatment to date of death or date of last follow-up if censored. (NCT00652899)
Timeframe: From first date on-study (treatment) to date of death

InterventionDays (Median)
Total Body Irradiation171.5
No Total Body Irradiation291

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Clinical Response Per the Response Evaluation Criteria in Solid Tumors (RECIST)

Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT00670748)
Timeframe: Approximately 3 years

,,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseProgressive DiseaseStable DiseaseNot Evaluable
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC36701
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa17701
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC11401
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa03200

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Number of Participants With Serious and Non-Serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00670748)
Timeframe: Date treatment consent signed to date off study, approximately, 66 months and 10 days

InterventionParticipants (Count of Participants)
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC17
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa16
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC7
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa5

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Number of Participants With In Vivo Survival of T-Cell Receptor (TCR)-Engineered Cells

Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR). This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells. (NCT00670748)
Timeframe: 1 month post treatment

InterventionParticipants (Count of Participants)
#1 Anti-NY-ESO-1 TCR PBL+HD IL-2 Mel/RCC16
#2 Anti-NY-ESO-1 TCR PBL+HD IL-2 OtherCa16
#3ESO1 TCR PBL+ALVAC ESO1+HD IL2 Mel/RCC6
#4ESO1 TCR PBL+ALVAC ESO1+HD IL2 OtherCa4

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Time to Engraftment (i.e., Absolute Neutrophil Recovery [ANC > 500/mm³] )

(NCT00691015)
Timeframe: post transplant, up to 4 weeks

InterventionDays (Median)
All Participants11

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Overall Survival.

(NCT00691015)
Timeframe: At 2 years after PBSCT

Interventionpercentage of participants (Number)
All Participants57.4

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Karnofsky Performance Status Performance Status

"100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment necessary.~10 - Moribund; fatal processes progressing rapidly. 0 - Dead" (NCT00691015)
Timeframe: At 90 days after PBSCT

Interventionunits on a scale (Median)
All Participants80

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Incidence of Acute Graft-versus-host Disease (GVHD)

(NCT00691015)
Timeframe: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria

Interventionpercentage of participants (Number)
All Participants44.7

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Incidence of Infections, Including Bacterial, Fungal, and Viral Infections (i.e., CMV and EBV Reactivation, Including Post-transplant Lymphoproliferative Disorders)

(NCT00691015)
Timeframe: Within 6 months after PBSCT

Interventionpercentage of participants (Number)
All Participants80.85

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Incidence of Chronic GVHD.

(NCT00691015)
Timeframe: Within 2 years after PBSCT

Interventionpercentage of participants (Number)
All Participants44.68

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Severity of Acute Graft-versus-host Disease (GVHD)

(NCT00691015)
Timeframe: Within 100 days after donor peripheral blood stem cell transplantation (PBSCT) as assessed by Glucksberg criteria

Intervention% of participants with severe aGVHD (Number)
All Participants33.3

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Clinical Response (Complete Response + Partial Response)

Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all lesions. Partial response is a 30% decrease in the sum of the longest diameter (LD) of target lesions. (NCT00704938)
Timeframe: 5 months

,
InterventionParticipants (Number)
Complete ResponsePartial Response
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC00
Anti-p53 TCR PBL + DC + IL-2: Other Histology00

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Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse events module. (NCT00704938)
Timeframe: 5 months

InterventionParticipants (Number)
Anti-p53 TCR PBL + DC + IL-2: Melanoma/RCC2
Anti-p53 TCR PBL + DC + IL-2: Other Histology1

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Chimerism

Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant. (NCT00719849)
Timeframe: 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant

,
InterventionParticipants (Count of Participants)
Day 7Day 14Day 21Day 28Day 56Day 806 months1 year2 years
Cyclophosphamide/Fludarabine/TBI001111222
Cyclophosphamide/Fludarabine/TBI/ATG001556777

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Incidence of Relapse at 2 Years

"Number of participants with relapse at 2 years.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated." (NCT00719849)
Timeframe: 2 years post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI1
Cyclophosphamide/Fludarabine/TBI/ATG5

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Incidence of Non-relapse Mortality at 6 Months

Number of Participants with Non-relapse Mortality at 6 Months (NCT00719849)
Timeframe: 6 months post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI2
Cyclophosphamide/Fludarabine/TBI/ATG2

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Incidence of Neutrophil Engraftment at Day 42

Number of participants with neutrophil engraftment at day 42 (NCT00719849)
Timeframe: Day 42 post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI3
Cyclophosphamide/Fludarabine/TBI/ATG7

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Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100

"Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)" (NCT00719849)
Timeframe: Day 100 post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI2
Cyclophosphamide/Fludarabine/TBI/ATG1

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Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100

"Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100.~Acute GVHD Staging and Grading:~Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death)" (NCT00719849)
Timeframe: Day 100 post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI3
Cyclophosphamide/Fludarabine/TBI/ATG6

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Probability of Survival at 1 Year

Kaplan-Meier estimate of the probability of survival at 1 year (NCT00719849)
Timeframe: 1 year post transplant

Interventionsurvival probability (Number)
Cyclophosphamide/Fludarabine/TBI0.25
Cyclophosphamide/Fludarabine/TBI/ATG0.50

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Incidence of Clinically Significant Infections at 6 Months

Number of participants with clinically significant infections at 6 months (NCT00719849)
Timeframe: 6 months post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI3
Cyclophosphamide/Fludarabine/TBI/ATG3

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Incidence of Clinically Significant Infections at 2 Years

Number of participants with clinically significant infections at 2 years (NCT00719849)
Timeframe: 2 years post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI3
Cyclophosphamide/Fludarabine/TBI/ATG3

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Incidence of Clinically Significant Infections at 1 Year

Number of participants with clinically significant infections at 1 year (NCT00719849)
Timeframe: 1 year post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI3
Cyclophosphamide/Fludarabine/TBI/ATG3

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Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year

"Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year.~Clinical Limited cGVHD~Oral abnormalities consistent with cGVHD, a positive skin or lip biopsy, and no other manifestations of cGVHD.~Mild liver test abnormalities (alkaline phosphatase <2 x upper limit of normal, AST or ALT <3 x upper limit of normal and total bilirubin <1.6) with positive skin or lip biopsy, and no other manifestations of cGVHD.~Less than 6 papulosquamous plaques, macular-papular or lichenoid rash involving <20% of body surface area (BSA), dyspigmentation involving <20% BSA, or erythema involving <50% BSA, positive skin biopsy, and no other manifestations of cGVHD.~Ocular sicca (Schirmer's test <5mm with no more than minimal ocular symptoms), positive skin or lip biopsy, and no other manifestations of cGVHD.~Vaginal or vulvar abnormalities with positive biopsy, and no other manifestations of cGVHD." (NCT00719849)
Timeframe: 1 year post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI0
Cyclophosphamide/Fludarabine/TBI/ATG3

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Incidence of Relapse at 1 Year

"Number of participants with relapse at 1 year.~Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated." (NCT00719849)
Timeframe: 1 year post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI1
Cyclophosphamide/Fludarabine/TBI/ATG4

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Incidence of Platelet Engraftment at 6 Months

Number of participants with platelet engraftment at 6 months (NCT00719849)
Timeframe: 6 months post transplant

InterventionParticipants (Count of Participants)
Cyclophosphamide/Fludarabine/TBI2
Cyclophosphamide/Fludarabine/TBI/ATG2

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Probability of Survival at 2 Years

Kaplan-Meier estimate of the probability of survival at 2 years (NCT00719849)
Timeframe: 2 years post transplant

Interventionsurvival probability (Number)
Cyclophosphamide/Fludarabine/TBI0.25
Cyclophosphamide/Fludarabine/TBI/ATG0.38

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Probability of Progression-free Survival at 2 Years

Kaplan-Meier estimate of the probability of progression-free survival at 2 years (NCT00719849)
Timeframe: 2 years post transplant

Interventionprogression free survival probability (Number)
Cyclophosphamide/Fludarabine/TBI0.25
Cyclophosphamide/Fludarabine/TBI/ATG0.25

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Probability of Progression-free Survival at 1 Year

Kaplan-Meier estimate of the probability of progression-free survival at 1 year (NCT00719849)
Timeframe: 1 year post transplant

Interventionprogression free survival probability (Number)
Cyclophosphamide/Fludarabine/TBI0.25
Cyclophosphamide/Fludarabine/TBI/ATG0.38

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Number of Participants With Graft Failure/Rejection

descriptive (NCT00723099)
Timeframe: By day 55

Interventionparticipants (Number)
Treatment (Chemotherapy, Transplant)3

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Time to Platelet Engraftment of > 20,000 Cells Per mm3

median and range (NCT00723099)
Timeframe: By 6 months

Interventiondays (Median)
Treatment (Chemotherapy, Transplant)46

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Median Time to ANC > 500

(NCT00723099)
Timeframe: By day 55

Interventiondays (Median)
Treatment (Chemotherapy, Transplant)18

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Overall Survival

Kaplan-Meier and cumulative incidence estimates will be used. (NCT00723099)
Timeframe: At 1 year

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)35

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Percent of Patients With Acute GVHD Grades III-IV

Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria (NCT00723099)
Timeframe: 100 days

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)12

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Percent of Patients With Chronic GVHD

Kaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria. (NCT00723099)
Timeframe: At 2 years

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)19

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Percent of Patients With Grade II-IV Acute Graft Versus Host Disease

Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria (NCT00723099)
Timeframe: By day 100

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)67

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Percent of Patients With Non-relapse Mortality

Kaplan-Meier and cumulative incidence estimates (NCT00723099)
Timeframe: 6 months

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)21

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Percent of Patients With Non-relapse Mortality

Kaplan-Meier and cumulative incidence estimates (NCT00723099)
Timeframe: 1 year

Interventionpercent of patients (Number)
Treatment (Chemotherapy, Transplant)38

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Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).

(NCT00727415)
Timeframe: After 6 months from study entry (end of treatment).

Interventionpercentage of participants (Number)
CR according to IgHV mutatedCR according to CD19+/CD38+, <30%CR according to CD19+/CD38+, >30%CR according to deletion 11q and 17p, absent
Phase I-II Lenalidomide28.0033.3316.6731.82

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Maximum Tolerated Dose of Lenalidomide (Phase I)

Maximum tolerated dose of lenalidomide given in combination with fludarabine. (NCT00727415)
Timeframe: The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.

Interventionnumber of patients without DLT (Number)
Dose level 1 - 5 mgDose level 2 - 10 mg
Phase I-II Lenalidomide61

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Number of Patients Reaching Disease-free Survival (DSF) Overall

Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular. (NCT00727415)
Timeframe: After 6 months from study entry (end of treatment)

Interventionpercentage of participants on DFS (Number)
Phase I-II Lenalidomide35.33

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Number of Patients With Severe Infections

Severe infection requiring more than 2 weeks of antibiotic therapy. (NCT00727415)
Timeframe: At 24 months from study entry (end of follow-up)

Interventionparticipants with severe infecitons (Number)
Phase I-II Lenalidomide2

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Overall Complete Response (CR) Rate (Phase II)

Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular. (NCT00727415)
Timeframe: After 6 months from study entry (end of treatment).

Interventionpercentage of patients in CR (Number)
Phase I-II Lenalidomide22.5

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Toxicity as Assessed by NCI CTCAE v3.0

Data from all subjects who receive any study drug will be included in the safety analyses. (NCT00727415)
Timeframe: At 24 months from study entry (end of follow-up)

InterventionParticipants who died during the study (Number)
Phase I-II Lenalidomide14

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Incidence of Grade II - IV Acute Graft-versus-host Disease

(NCT00775931)
Timeframe: by Day 100 after transplant

InterventionParticipants (Count of Participants)
Marrow Graft Transplant Conditioning2
Cord Blood Transplant Conditioning0

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Number of Patients Who Achieved Donor Cell Engraftment

(NCT00775931)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Marrow Graft Transplant Conditioning5
Cord Blood Transplant Conditioning0

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Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation

Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 30

Interventionparticipants (Number)
Haploidentical Transplant18

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Overall Survival at Day 100

Overall survival is assessed, without regard to disease status, post-transplant, at Day 100. (NCT00782379)
Timeframe: Day 100

Interventionparticipants (Number)
Haploidentical Transplant17

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Overall Survival at 12 Months

Overall survival, defined as a patient being alive after transplant, is without regard to disease status. (NCT00782379)
Timeframe: 12 months

Interventionparticipants (Number)
Haploidentical Transplant14

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Disease Free Survival at Day 100

Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point. (NCT00782379)
Timeframe: Day 100

Interventionparticipants (Number)
Haploidentical Transplant16

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Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT)

(NCT00782379)
Timeframe: Day 100

Interventionparticipants (Number)
Haploidentical Transplant2

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Incidence of Graft Rejection for Patients at Day 100

Number of patients who experienced graft rejection by Day 100 (NCT00782379)
Timeframe: Day 100

Interventionparticipants (Number)
Haploidentical Transplant0

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Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT)

Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease. (NCT00782379)
Timeframe: 1 year

Interventionparticipants (Number)
Haploidentical Transplant2

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Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4)

Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence (NCT00782379)
Timeframe: Day 100

Interventionparticipants (Number)
Haploidentical Transplant2

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Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 60

Interventionparticipants (Number)
Haploidentical Transplant18

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Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00782379)
Timeframe: Day 90

Interventionparticipants (Number)
Haploidentical Transplant13

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Disease Free Survival at 12 Months

Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point. (NCT00782379)
Timeframe: 12 months

Interventionparticipants (Number)
Haploidentical Transplant7

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Non-relapse Mortality (NRM) at Day 180 Post-transplantation

non-relapse mortality refers to the death of a patient for causes other than relapsed disease. (NCT00787761)
Timeframe: Day 180

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan0

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Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)

Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. (NCT00787761)
Timeframe: 2 years

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan13

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Number of Patients Who Experience Severe (Grade 3 or 4) Acute Graft-versus-host Disease

number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea. (NCT00787761)
Timeframe: Day 100

Interventionparticipants (Number)
Severe Graft Versus Host Disease2

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Overall Survival (OS) at 24 Months

Overall survival refers to the length of time a patient is alive after transplant regardless of whether they have progressive or relapsed disease. (NCT00787761)
Timeframe: 24 months

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan16

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T-cell and Myeloid Chimerism at Days 180 Post-transplantation (>90%)

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: 180 days

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan19

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T-cell and Myeloid Chimerism at Days 90 Post-transplantation (>90% Chimerism)

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: Day 90

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan17

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Achievement of > 90% (Full) Donor Chimerism in the T-cell Lineage as Measured by PCR at Day 30 Post-transplantation

Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. (NCT00787761)
Timeframe: Day 30

Interventionparticipants (Number)
Transplant Recipients12

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Disease-free Survival (DFS) at 24 Months

Disease Free survival is measured by the amount of time a patient spends in a disease free state after being transplanted. (NCT00787761)
Timeframe: 24 months

Interventionparticipants (Number)
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan13

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Number of Participants Who Experienced Chronic Extensive GVHD

Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. (NCT00789776)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)2
Dose 2 (5.0 x 10^6/kg NK Cells)3

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Number of Participants With Relapsed Disease

"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions." (NCT00789776)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)1
Dose 2 (5.0 x 10^6/kg NK Cells)10

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Number of Non-relapse Participant Mortalities

Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression. (NCT00789776)
Timeframe: Day 200

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)0
Dose 2 (5.0 x 10^6/kg NK Cells)0

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Number of Subjects Surviving Post-transplant.

Number of subjects surviving post-transplant. (NCT00789776)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)5
Dose 2 (5.0 x 10^6/kg NK Cells)25

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Number of Participants With Grades III-IV Acute GVHD

"Number of patients who developed acute GVHD post-transplant. aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death" (NCT00789776)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)1
Dose 2 (5.0 x 10^6/kg NK Cells)0

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Number of Participants With Dose Limiting Toxicities

Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality. (NCT00789776)
Timeframe: Day 35 (28 days after NK cell infusion)

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)0
Dose 2 (5.0 x 10^6/kg NK Cells)0

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Number of Participants Who Experienced Graft Failure

Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts >2 weeks and is refractory to growth factor support. (NCT00789776)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Dose 1 (2.5 x 10^6/kg NK Cells)0
Dose 2 (5.0 x 10^6/kg NK Cells)4

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Number of Patients Surviving Progression-free

"Number of subjects surviving without progressive disease post-transplant.~Progressive disease criteria:~Greater than 25% increase in serum (absolute increase must be ≥0.5 g/dL) or urine (absolute increase must be ≥200 mg/24h) M proteins compared to best response status after autologous transplant.~Appearance of new lytic bone lesions or plasmacytomas." (NCT00793572)
Timeframe: At 2 years after the autograft

InterventionParticipants (Count of Participants)
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy14

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Number of Patients Surviving Overall

Number of subjects surviving two years post autologous transplant. (NCT00793572)
Timeframe: At 2 years after the autograft

InterventionParticipants (Count of Participants)
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy21

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Number of Patients With Non-relapse Mortality

Number of subjects with non-relapse mortalities post allogeneic transplant. (NCT00793572)
Timeframe: 200 and 365 days after allo

InterventionParticipants (Count of Participants)
200 days post allo1 Year post allo
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy11

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Number of Patients With Grade II-IV Acute GVHD

"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~- a maculopapular eruption involving < 25% BSA~- a maculopapular eruption involving 25 - 50% BSA~- generalized erythroderma~- generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~- bilirubin 2.0 - 3.0 mg/100 mL~- bilirubin 3 - 5.9 mg/100 mL~- bilirubin 6 - 14.9 mg/100 mL~- bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT00793572)
Timeframe: 100 days post allo transplant

InterventionParticipants (Count of Participants)
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy14

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Number of Patients With Chronic GVHD

Number of subjects with classic chronic or chronic extensive GVHD post allogeneic transplant. (NCT00793572)
Timeframe: 1 year post allo

InterventionParticipants (Count of Participants)
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy10

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Overall Survival (OS) Rate

OS was defined as the time from the initiation of treatment to last follow-up date or death. OS were calculated using Kaplan-Meier estimates. (NCT00794820)
Timeframe: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.

InterventionPercentage of Participants (Number)
FCR-Multiple Dose Rituximab58

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Remission Duration/Time to Progression (TTP)

TTP was defined as time from initiation of treatment to primary refractory disease or CLL progression. TTP was censored for therapy-related myelodysplastic syndrome (t-MDS) or acute myelogenous leukemia (t-AML) and death in remission. TTP calculated using Kaplan-Meier estimates. (NCT00794820)
Timeframe: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014.

InterventionMonths (Median)
FCR-Multiple Dose Rituximab81

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Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months

CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; Progressive disease (PD): ≥ 50% rise in lymphocyte count to > 5 x109/L, ≥ 50% increase in lymphadenopathy, ≥ 50% increase in liver or spleen size, Richter's transformation, or new cytopenias due to CLL; Stable disease, defined as not meeting criteria for CR, CRi, PR or PD. (NCT00794820)
Timeframe: 6 months

InterventionPercentage of Participants (Number)
FCR-Multiple Dose Rituximab75

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Number of Participants Surviving up to 2 Years Without Disease Progression

Progression-free survival is the time interval from start of treatment to documented evidence of disease progression. Disease progression was defined by European LeukemiaNet 2017 criteria and International Working Group (IWG) within 3 years of transplant. (NCT00796068)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)37
Arm II (High Risk for Graft Failure)41

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Number of Participants With Acute Graft-versus-host Disease (GVHD) Grade II-IV by Day 100

Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. Diagnosing and grading acute GVHD is based on clinical findings (the organ stage, response to treatment and whether GVHD was a major cause of death) and frequently varies between transplant centers and independent reviewers. (NCT00796068)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)36
Arm II (High Risk for Graft Failure)37

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Number of Participants With Graft Failure/Rejection

"Patients will be considered primary graft failure provided they meet any criteria listed below, in the absence of documented disease persistence/recurrence or active bone marrow infection (ex. Cytomegalovirus (CMV)):~i. Absence of 3 consecutive days with neutrophils >500/u1 combined with host CD3+ peripheral blood chimerism ≥50% at day 42 ii. Absence of 3 consecutive days with neutrophils >500/u1 under any circumstances at day 55 iii. Death after day 28 with neutrophil count <100/u1 without any evidence of engraftment (< 5% donor CD3+) iv. Primary autologous count recovery with < 5% donor CD3+ peripheral blood chimerism at count recovery and without relapse" (NCT00796068)
Timeframe: Up to 100 days

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)2
Arm II (High Risk for Graft Failure)5

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Number of Participants With Secondary Graft Failure

Secondary graft failure is defined as decline of neutrophil count to <500/ul with loss of donor chimerism after day 55 (NCT00796068)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)0
Arm II (High Risk for Graft Failure)0

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The Number of Participants Alive at Two-years Follow up.

Overall survival of participants after two-years of follow up. (NCT00796068)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)50
Arm II (High Risk for Graft Failure)44

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Number of Patients With Non-relapse Mortality (NRM)

Defined as death from any cause without sign of disease progression or relapse. Loss to follow up are censored, whereas disease relapse or progression are considered competing risks. (NCT00796068)
Timeframe: At day -200

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)7
Arm II (High Risk for Graft Failure)6

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Duration (Days) Until Participants Obtained Platelet Engraftment

Summarized using a range and median of measure in days until participants reached platelet engraftment. Platelet engraftment was defined as the first of 7 consecutive days when the platelet count exceeded 20 x 109/L (untransfused). (NCT00796068)
Timeframe: At 6 months

Interventiondays (Median)
Arm I (Low Risk for Graft Failure)31
Arm II (High Risk for Graft Failure)31

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Incidence of Acute or Chronic Graft-versus-host Disease (GVHD)

Overall GVHD is determined based on the organ stage, response to treatment and whether GVHD was a major cause of death. Chronic GVHD will be defined according to the National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease. Described as mild, moderate, or severe as graded according to the attached Organ Scoring Sheet. Symptoms consistent with both chronic and acute GVHD occurring after day 100 will be considered overlap chronic GVHD syndrome. (NCT00796068)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)7
Arm II (High Risk for Graft Failure)6

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Incidence of Clinically Significant Infections

Collected and graded according to the modified National Cancer Institute Common Toxicity Criteria. (NCT00796068)
Timeframe: At 6 months

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)53
Arm II (High Risk for Graft Failure)61

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Incidence of Relapse or Disease Progression

Cumulative incidence estimates using non-relapse mortality as competitive event. (NCT00796068)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)17
Arm II (High Risk for Graft Failure)11

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Non-relapse Mortality

Death of any cause other than relapse or disease progression was considered. (NCT00796068)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)8
Arm II (High Risk for Graft Failure)10

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Number of Participants Surviving by 1 Year

Overall survival was measured from the first day of CBT infusion until death from any cause. (NCT00796068)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Arm I (Low Risk for Graft Failure)51
Arm II (High Risk for Graft Failure)47

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2-year Overall Survival

Overall Survival (OS) is defined as the interval between day of transplant and day of death. (NCT00800839)
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 years

Interventionpercentage of participants (Number)
Busulfan + Fludarabine + Cyclophosphamide33

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2-year Progression-Free Survival

Progression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression. (NCT00800839)
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 years

Interventionpercentage of participants (Number)
Busulfan + Fludarabine + Cyclophosphamide26

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Cumulative Incidence of Grade II to IV Acute GVHD

Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD. (NCT00800839)
Timeframe: 100 days post transplant

Interventionpercentage of incidence (Number)
Busulfan + Fludarabine + Cyclophosphamide53

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Cumulative Incidence of Grade III to IV Acute GVHD

Graft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD. (NCT00800839)
Timeframe: 100 days post transplant

Interventionpercentage of incidence (Number)
Busulfan + Fludarabine + Cyclophosphamide22

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Rate of Engraftment

Engraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors. (NCT00800839)
Timeframe: From engraftment to 60 days post transplant

Interventiondays (Median)
Busulfan + Fludarabine + Cyclophosphamide18

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Number of Participants With Molecular Response

Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML. (NCT00813124)
Timeframe: 12 month post BMT

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseProgressive Disease
Azacytidine Maintenance After Allotx804

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Overall Survival at 1 Year

Evaluation of overall survival at 1 year (# of patients who are alive at 1 year post-transplant) (NCT00818961)
Timeframe: 1 year

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation26

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Non-relapse Mortality at 1 Year Post-transplant

Number of patients who died of non-relapse causes at one year. this is in clusive of all patients who were transplanted on study even though only 10 patients died at by 1 year time point. This outcome will be referenced in the donor chimerism outcome. Only 26/36 patients were eligible for this time point as that is all that were alive. (NCT00818961)
Timeframe: 1 year

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation4

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Neutrophil Recovery

The number of patients experiencing neutrophil recovery post transplant (NCT00818961)
Timeframe: Day 100

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation35

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Number of Patients Requiring the Use of Donor Leukocyte Infusion (DLI) for Early Mixed T-cell Chimerism

DLI is used for patients with mixed chimerism following transplant (NCT00818961)
Timeframe: Day 100

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation19

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Platelet Engraftment

The number of patients experiencing platelet engraftment post-transplant (NCT00818961)
Timeframe: Day 100

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation35

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Number of Patients Experiencing Grade 2-4 Acute Graft-versus-host Disease Post-transplant

patients experiencing acute graft versus host disease post-transplant (NCT00818961)
Timeframe: patients were followed for 2 years

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation15

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Number of Patients Experiencing Veno-occlusive Disease (VOD) Post-transplant

Patients will be evaluated up to 4 years post transplant (NCT00818961)
Timeframe: 4 years

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation0

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Non-relapse Mortality at Day 100

patients are evaluable for their cause of death at Day 100 (NCT00818961)
Timeframe: Day 100

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation1

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Complete Donor Chimerism

Complete donor chimerism (defined as >/= 95% donor cells in peripheral blood CD3+ and CD33+ was measured. (NCT00818961)
Timeframe: 2 years

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation26

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Survival at Day 100

Survival at Day 100 (NCT00818961)
Timeframe: 100 day

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation35

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Number of Patients Experiencing Chronic Graft Versus Host Disease

(NCT00818961)
Timeframe: >100 days post-transplant

Interventionparticipants (Number)
Hematopoietic Stem Cell Transplantation20

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Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30

Number of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC >0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC <0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy. (NCT00822770)
Timeframe: 30 Days post engraftment

InterventionParticipants (Count of Participants)
Overall Study: Plerixafor + G-CSF32

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Number of Participants Alive With no Disease Progression at Time of Allo Transplant

In Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0. (NCT00822770)
Timeframe: Baseline till transplant, Day -9 to Day 0, to 10 days

Interventionpercentage of participants (Number)
Participants inParticipants not in Complete Remission
Overall Study: Plerixafor + G-CSF1616

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Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor

Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant). (NCT00822770)
Timeframe: 28 day cycle (Plerixafor Day -7 to Day -4)

Interventionparticipants (Number)
0 mcg/kg daily80 mcg/kg daily160 mcg/kg daily240 mcg/kg daily
Phase I Plerixafor + G-CSF1474

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Number of Patients That Engrafted Blood Counts by 30 Days After Transplant

Number of patients whose Absolute Neutrophil Count (ANC) recovered to >500 x10^3/uL for at least 3 consecutive days after transplant (NCT00827099)
Timeframe: Day 30

Interventionparticipants (Number)
Umbilical Cord Blood Transplant5

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Rate of Complete Donor Chimerism - Blood

"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics." (NCT00856388)
Timeframe: Day 30

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)89

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Median Time to Platelet Engraftment

"Median Time to Platelet Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Day 100

InterventionDays (Median)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)17.0

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Rate of Complete Donor Chimerism - Blood

"Rate of Complete Donor Chimerism - Blood~Summarized using standard descriptive statistics." (NCT00856388)
Timeframe: Day 100

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)94

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Median Time to ANC Engraftment

"Median Time to ANC Engraftment~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Days 30

InterventionDays (Median)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)16.5

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Day 100 TRM

Day 100 Treatment Related Mortality An exact 95% confidence interval will be provided. (NCT00856388)
Timeframe: First 100 days

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)8.44

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Acute GVHD Grade III-IV

"Acute GVHD grade III-IV~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Up to day 100

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)27

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1 yr Extenstive Chronic GVHD

"1 yr Extensive Chronic GVHD~Summarized using standard descriptive statistics along with corresponding 95% confidence intervals." (NCT00856388)
Timeframe: Up to 4.5 years

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)60

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3 yr Overall Survival

3 yr Overall Survival estimated using the Kaplan-Meier method. (NCT00856388)
Timeframe: Up to 4.5 years

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)46.0

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Incidence of Chronic GVHD

(NCT00860574)
Timeframe: at 6 months

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)20

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Incidence of Grades II-IV Acute GVHD

(NCT00860574)
Timeframe: at 6 months

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)57

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Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood

Donor chimerism was evaluated in peripheral blood T cells (NCT00860574)
Timeframe: Day 28 after HCT

Interventionpercentage of T cells (Median)
Treatment (Allogeneic Transplantation)100

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Non Relapse Mortality (NRM) Incidence

Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression. (NCT00860574)
Timeframe: At 6 months

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)6

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Relapse-free Survival

(NCT00860574)
Timeframe: at 2 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)62

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Relapse Incidence

(NCT00860574)
Timeframe: At 6 months

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)18

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Overall Survival (OS)

(NCT00860574)
Timeframe: at 2 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)71

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Non Relapse Mortality Incidence

(NCT00860574)
Timeframe: 1 year after HCT

InterventionParticipants (Count of Participants)
Treatment (Allogeneic Transplantation)6

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Number of Patients With Complete Remission of Disease

Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis). (NCT00871689)
Timeframe: Day 100

InterventionParticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant1

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Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease

"Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant." (NCT00871689)
Timeframe: Day 100 Post Transplant

Interventionparticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant0

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Number of Patients With Acute Graft-Versus-Host (GVHD) Disease

"Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.~Acute GVHD usually happens within the first 3 months after transplant." (NCT00871689)
Timeframe: Day 100 Post Transplant

Interventionparticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant1

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Number of Patients With Neutrophil Engraftment

Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant. (NCT00871689)
Timeframe: Day 42

InterventionParticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant1

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Number of Patients With Successful Natural Killer Expansion

Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl. (NCT00871689)
Timeframe: Day 72 Post Transplant

Interventionparticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant1

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Median Overall Survival

Average number of days the patients were alive after receiving UCB transplantation. (NCT00871689)
Timeframe: Month 6

InterventionDays (Median)
Patients Receiving Double Umbilical Cord Blood Transplant98.5

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Incidence of Primary Graft Failure

Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42. (NCT00871689)
Timeframe: Day 42

InterventionParticipants (Number)
Patients Receiving Double Umbilical Cord Blood Transplant1

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Kaplan Meier Estimate of Time to Treatment Failure (TTF) as Assessed by the Investigator

Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From the date of the first treatment to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm

Interventionweeks (Median)
Lenalidomide24.4
Investigators Choice17.9

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Kaplan Meier Estimate of Time to Progression as Assessed by the Investigator at the Final Analysis

Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm

InterventionWeeks (Median)
Lenalidomide39.3
Investigators Choice24.7

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Kaplan Meier Estimate of Time to Progression According to the IRC Central Review

Time to progression (TTP) was defined as the time from randomization until objective tumor progression. Time to progression did not include deaths. Participants without progression at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new anti-lymphoma treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm

InterventionWeeks (Median)
Lenalidomide39.3
Investigators Choice24.7

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Kaplan Meier Estimate of Time to First Response as Assessed by the Investigator at the Final Analysis

Time to first response was defined as the time from first dose of study drug to the date of the first response (having at least a PR). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the subject was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm

InterventionWeeks (Median)
Lenalidomide23.9
Investigators Choice40.0

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Kaplan Meier Estimate of Time to First Response (TTFR) According to the IRC Central Review

Time to Response was defined as the time from first dose of study drug to the date of the first response (having at least a PR) and was calculated only for responding participants. ). Participants with progression at the time of analysis were censored at the first assessment date that the participant was known to have progressed. Participants with SD at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From randomization of study drug to time of first documented PR or better response; up to data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm

InterventionWeeks (Median)
Lenalidomide18.7
Investigators ChoiceNA

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Kaplan Meier Estimate for Progression Free Survival by Investigator's Assessment at the Final Analysis

Kaplan Meier estimates of PFS were defined as the time from randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last completed assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to study discontinuation of 09 October 2018; overall median follow-up time was 285 weeks

Interventionweeks (Median)
Lenalidomide37.3
Investigators Choice23.6

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Kaplan Meier Estimate for Progression Free Survival (PFS) by Independent Review Committee (IRC) Central Review

PFS was defined as time of randomization to the first observation of disease progression or death due to any cause, whichever was first. If a participant had not progressed or died, PFS was censored at the time of last assessment when the participant was known not to have progressed. For participants who received other anti-lymphoma therapy with no evidence of progression, PFS was censored at time of last tumor assessment with no evidence of progression prior to the start of new anti-lymphoma treatment. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to data cut off date of 07 March 2014; overall median follow-up time was 93.9 weeks

Interventionweeks (Median)
Lenalidomide37.6
Investigators Choice22.7

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Kaplan Meier Estimate for Overall Survival as Assessed by the Investigator at the Final Analysis

Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From randomization to progression of disease or death; up to the study discontinuation date of 09 October 2018; overall median follow-up time was 285 weeks

Interventionweeks (Median)
Lenalidomide120.6
Investigators Choice91.7

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Kaplan Meier Estimate for Overall Survival (OS) According to the IRC Central Review

Overall survival was defined as the time from randomization until death from any cause. Participants alive or lost to follow-up at the time of analysis were censored at the last date they were known to be alive. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; overall median follow-up was 93.9 weeks

Interventionweeks (Median)
Lenalidomide121.0
Investigators Choice91.7

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Kaplan Meier Estimate of Time to Treatment Failure as Assessed by the Investigator at the Final Analysis

Time to treatment failure was defined as the time from the first dose of study drug to discontinuation of treatment for any reason, including disease progression assessed by the investigator, treatment toxicity, or death. Participants who were on-treatment or completed the treatment according to the protocol were censored at the last date of drug intake. (NCT00875667)
Timeframe: From date of first dose of treatment to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm

Interventionweeks (Median)
Lenalidomide24.4
Investigators Choice17.9

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Kaplan Meier Estimate for Duration of Response (DOR) According to the IRC Central Review

Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median study duration was 70.7 weeks for the lenalidomide arm and 69.3 weeks for the investigators choice arm

InterventionWeeks (Median)
Lenalidomide69.6
Investigators Choice45.1

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Percentage of Participants Who Achieved an Overall Response as Assessed by the Investigator at the Final Analysis

Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response, Complete Response unconfirmed or Partial Response. Participants who had discontinued before any response has been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm

InterventionPercentage of Participants (Number)
Lenalidomide45.9
Investigators Choice22.6

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Kaplan Meier Estimate for Duration of Response as Assessed by the Investigator at the Final Analysis

Duration of response was defined as the time from when the first response of CR, CRu, or PR was first achieved until documented tumor progression, or until the participant died from any cause, whichever occurred first. Participants who did not progress or die at the time of analysis were censored at the last assessment date that the participant was known to be progression-free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participant was known to be progression-free. (NCT00875667)
Timeframe: From date of randomization to the study discontinuation date of 09 October 2018; median study duration was 103.9 weeks for lenalidomide and 87.0 weeks for the investigator choice arm

InterventionWeeks (Median)
Lenalidomide70.1
Investigators Choice91.7

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Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease According to the IRC Central Review

Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm

InterventionPercentage of Participants (Number)
Lenalidomide69.4
Investigators Choice63.1

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Percentage of Participants With a Complete Response, Unconfirmed Complete Response, Partial Response and Stable Disease at the Final Analysis

Tumor control rate was defined as the percentage of participants with a complete response (CR), unconfirmed complete response (CRu), partial response (PR) and stable disease (SD). Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999); CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. Stable disease (SD) is defined as less than a PR (see above) but is not progressive disease or relapsed disease. (NCT00875667)
Timeframe: From date of randomization to the discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm

InterventionPercentage of participants (Number)
Lenalidomide70.0
Investigators Choice65.5

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Mean Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice21.2-0.80.04.25.60.8
Lenalidomide26.5-1.6-1.4-2.91.46.0

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Mean Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice16.2-0.85.1-12.5-11.15.4
Lenalidomide18.12.51.9-2.3-4.34.8

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Maximum Change From Baseline in the EORTC QLQ-C30 Insomnia Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-12.8
Investigators Choice-7.6

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Mean Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice83.6-2.31.34.25.6-2.3
Lenalidomide84.60.0-1.9-3.2-2.5-5.1

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Maximum Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain to Treatment Scale was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide4.6
Investigators Choice5.6

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Percentage of Participants Who Achieved an Overall Response According to the IRC Central Review

Overall Response Rate (ORR) was defined as the percentage of participants whose best response was Complete Response (CR), Complete Response unconfirmed (CRu) or Partial Response (PR). Participants who discontinued before any response had been observed or changed to other anti-lymphoma treatments before response had been observed, were considered as non-responders. Tumor Response was assessed by a modification of the International Lymphoma Workshop Response Criteria, IWRC, Cheson, 1999; CR is defined as the disappearance of all clinical and radiographic evidence of disease; CRu is defined as a CR, with a 1) residual lymph node mass >1.5 cm that has decreased by 75% in the sum of the product of the diameters (SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2) indeterminate bone marrow; PR = is defined ≥50% decrease in 6 largest nodes or nodal masses. (NCT00875667)
Timeframe: From date of randomization to the data cut-off date of 07 March 2014; median treatment duration was 24.3 weeks for the lenalidomide arm and 13.1 weeks for the investigators choice arm

InterventionPercentage of Participants (Number)
Lenalidomide40.0
Investigators Choice10.7

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Maximum Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-10.9
Investigators Choice-2.3

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Maximum Change From Baseline in the EORTC QLQ-C30 Fatigue Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-4.9
Investigators Choice-2.9

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Maximum Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide6.9
Investigators Choice3.7

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Maximum Change From Baseline in the EORTC QLQ-C30 Dyspnoea Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-7.3
Investigators Choice-5.8

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Maximum Change From Baseline in the EORTC QLQ-C30 Diarhoea Domain to Treatment Discontinuation Visit

"The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Diarhoea Scale was scored between 0 and 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement." (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014

Interventionunits on a scale (Least Squares Mean)
Lenalidomide-7.2
Investigators Choice-5.8

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Maximum Change From Baseline in the EORTC QLQ-C30 Constipation Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-0.3
Investigators Choice-3.5

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Maximum Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide3.2
Investigators Choice2.9

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Maximum Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Domain to Treatment Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-4.8
Investigators Choice-4.1

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Mean Change From Baseline in the EORTC QLQ-C30 Constipation

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Domain was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice8.6-0.81.30.00.00.8
Lenalidomide12.56.34.23.5-0.710.2

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Mean Change From Baseline in the EORTC QLQ-C30 Diarhoea

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarhoea Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice12.6-3.11.3-4.20.00.0
Lenalidomide15.7-3.5-4.22.4-2.11.6

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Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice78.51.31.3-3.11.4-1.5
Lenalidomide73.73.43.68.14.5-1.3

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Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice39.22.13.4-6.9-7.42.6
Lenalidomide40.20.1-3.2-1.0-3.95.2

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Mean Change From Baseline in the EORTC QLQ-C30 Financial Problems Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Problems Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice10.8-0.8-3.8-4.2-5.61.6
Lenalidomide19.5-7.0-7.0-2.9-9.2-4.3

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Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status / QoL Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status / QoL Domain was scored between 0 and 100, with a higher score representing a higher quality of life. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice58.42.33.27.38.3-1.0
Lenalidomide59.0-3.4-0.71.04.3-5.8

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Mean Change From Baseline in the EORTC QLQ-C30 Insomnia Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice25.7-4.7-6.4-16.7-16.70.8
Lenalidomide29.4-7.6-5.2-1.8-7.1-3.2

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Mean Change From Baseline in the EORTC QLQ-C30 Nausea / Vomiting Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice3.80.45.82.12.86.6
Lenalidomide4.92.52.65.3-0.70.5

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Mean Change From Baseline in the EORTC QLQ-C30 Pain Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Domain was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineCycle 3 Day 1Cycle 5 Day 1Cycle 7 Day 1Cycle 9 Day 1Treatment Discontinuation
Investigators Choice13.7-1.2-2.60.0-2.83.5
Lenalidomide22.6-2.2-0.23.2-3.24.6

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Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice78.9-3.7-2.14.211.1-5.1
Lenalidomide71.8-0.51.62.42.8-5.6

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Mean Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice73.93.5-6.40.013.9-4.3
Lenalidomide71.5-4.81.40.31.8-9.1

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Mean Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Domain ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

,
Interventionunits on a scale (Mean)
BaselineChange from Baseline to Cycle 3 Day 1Change from Baseline to Cycle 5 Day 1Change from Baseline to Cycle 7 Day 1Change from Baseline to Cycle 9 Day 1Change from Baseline to Treatment Discontinuation
Investigators Choice78.4-1.2-4.52.10.0-2.7
Lenalidomide74.9-1.01.6-1.54.3-5.1

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Number of Participants With Treatment Emergent Adverse Events

Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3: according to the following scale: Grade 1 = Mild Adverse Event (AE), Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death; Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. after the first dose of study drug and within 28 days after the last dose. A Treatment Emergent Adverse event (TEAE) is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. (NCT00875667)
Timeframe: From the date of the first dose of study drug to 28 days after the last dose, up to the study discontinuation date of 09 October 2018; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigators choice arm

,
InterventionParticipants (Count of Participants)
Any TEAEAny TEAE Grade 3 AEAny TEAE Grade 4 AEAny TEAE Grade 5 AEAny TEAE Related to the IPAny Grade 3 AE Related to IPAny Grade 4 AE Related to IPAny Grade 5 AE Related to IPAny Serious Adverse Event (SAE)Any SAE Related to IPAny TEAE Leading to Stopping of IPAny Treatment Related AE Leading to Stopping IPTEAE Leading to Dose Reduction/InterruptionRelated AE Leading to Dose Reduct/InterruptionTEAE Leading to Dose ReductionRelated AE Leading to Dose ReductionTEAE Leading to Dose InterruptionRelated AE Leading to Dose Interruption
Investigators Choice694929251361902212147332913102825
Lenalidomide159126561514110646075383118114103726911098

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Maximum Change From Baseline in the EORTC QLQ-C30 Nausea and Vomiting Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea and Vomiting Scale was scored between 0 and 100, with a high score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide-2.3
Investigators Choice-0.6

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Maximum Change From Baseline in the EORTC QLQ-C30 Pain Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale was scored between 0 and 100, with a higher score representing worse symptomatic expression. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and time of discontinuation from treatment visit.Up to final data cut-0ff date of 07 March 2014

Interventionunits on a scale (Mean)
Lenalidomide-5.8
Investigators Choice-3.5

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Maximum Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide3.4
Investigators Choice-1.8

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Maximum Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide3.1
Investigators Choice5.0

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Maximum Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain to Treatment Discontinuation Visit

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale ranges from 0 to 100, with a high score indicating better functioning. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00875667)
Timeframe: Baseline known as screening visit, after cycle 2 (C3D1), after Cycle 4 (C5D1), after Cycle 6, (C7D1), after Cycle 8, (C9D1) and at discontinuation; median treatment duration was 24.3 weeks for lenalidomide and 13.1 weeks for the investigator choice arm.

Interventionunits on a scale (Mean)
Lenalidomide5.1
Investigators Choice3.8

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Percentage of Participants With GVHD (Graft Versus Host Disease)

Acute grade 2 to 4 Graft versus host disease( GVHD )for patients who were able to be analyzed by measuring the T cell counts for increased CD3+ before and after lenalidomide. (NCT00899431)
Timeframe: Up to 6 months after allotransplant

InterventionParticipants (Count of Participants)
Group 10
Group 23
Group 31

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Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant

Graft failure is defined as either a failure to reach an ANC of >500/uL for 3 consecutive days by day 28 post-transplant, or an irreversible decrease in ANC <100 after an established donor graft, unless there is a reasonable explanation such as a viral infection or drug effect that may be responsible for a reversible decrease in ANC. (NCT00914940)
Timeframe: Up to 5 years post transplant

InterventionParticipants (Count of Participants)
Overall Study Participants0

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Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant

Relapse is defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology. Testing for recurrent malignancy in the blood and bone marrow performed by monitoring the CBC and bone marrow at Day 28, 58, 80, 360, and as needed for suspected relapse. (NCT00914940)
Timeframe: Up to 5 years post transplant

InterventionParticipants (Count of Participants)
Overall Study Participants10

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Number of Participants With Chronic GVHD

Chronic GVHD measured by meeting NIH criteria and treated with immune suppression (NCT00914940)
Timeframe: Up to 5 years post transplant

InterventionParticipants (Count of Participants)
Chronic GVHD that meets NIH criteriaNo documented chronic GVHD
Overall Study Participants335

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To Estimate the Rate of Conversion of Partial Response (PR) to Complete Response (CR) After Fludarabine, Cyclophosphamide and Rituximab (FCR) Plus Vorinostat

Responses were measured after completion of FCR+ vorinostat induction therapy (within 21 days of starting maintenance) and again after completion of maintenance therapy (24 months after the start of maintenance therapy). Maintenance therapy began within 3 months after completion of induction therapy with FCR+vorinostat. Criteria for response are specified by the National Cancer Institute (NCI) working group guidelines; in addition, patients were required to meet computed tomography (CT) criteria as described in the protocol. Response categories include Complete Response (CR), Partial Response (PR), Nodular Partial Response (nPR), Stable Disease (SD) or Progressive Disease (PD). (NCT00918723)
Timeframe: After completion of maintenance therapy (24 months after start of maintenance)

Interventionpercentage of participants (Number)
Conversion from PR to CRConversion from nPR (nodular PR) to CR
Treatment (Induction and Maintenance Chemotherapy)50100

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Percentage of Patients With Progression-free Survival at 2 Years

"Progression-free survival (PFS): The length of time during and after the treatment that a patient lives with the disease but it does not get worse.~Progressive disease is specified by the NCI (National Cancer Institute) working group guidelines and additional CT (computerized tomography) scan requirements:~Lymphadenopathy, > 50% increase in the sum of the products of at least two lymph nodes on two consecutive determinations; one lymph node must be at least 2 cm.~An increase in the liver or spleen size by 50% or more by CT scan or the de novo appearance of hepatomegaly or splenomegaly.~An increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter.~Transformation to a more aggressive histology or occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL." (NCT00918723)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Treatment (Induction and Maintenance Chemotherapy)87

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Overall Survival

Overall survival (OS): The percentage of people in a study who are still alive at for a certain period of time after they started treatment. (NCT00918723)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Treatment (Induction and Maintenance Chemotherapy)90

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Maximum Tolerated Dose (MTD) of Vorinostat That Can be Combined With Fludarabine Phosphate, Cyclophosphamide and Rituximab (FCR) (Phase I)

"The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.~Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg." (NCT00918723)
Timeframe: 28 days

Interventionmg (Number)
MTD for Vorinostat During Induction Therapy400
MTD for Vorinostat During Maintenance Therapy400

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Number of Participants With Infections

Number of participants with clinically significant infections (bacterial, fungal, viral) requiring treatment within 100 days following transplant (NCT00919503)
Timeframe: 100 days post transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)57
Regimen B (UBCT)9

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Preliminary Efficacy

Number of patients engrafted (>5% donor CD3+ peripheral blood chimerisms) at 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)83
Regimen B (UBCT)10

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Number of Patients With of Chronic Graft-versus-host Disease

Number of patients diagnosed with chronic GVHD and requiring systemic immunosuppression within 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)29
Regimen B (UBCT)5

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Number of Patients With Grade II-IV Acute Graft-versus-host Disease

Number of patients diagnosed with overall grade II-IV acute GVHD by Day 100 post transplant (NCT00919503)
Timeframe: Day 100 post transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)44
Regimen B (UBCT)8

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Non-relapse Mortality

Number of patients who experienced non-relapse mortality by 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)2
Regimen B (UBCT)5

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Immune Reconstitution Following Hematopoietic Cell Transplantation

Number of patients with immune reconstitution (defined by a normal range CD3) at 1 year post transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)39
Regimen B (UBCT)4

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Disease Response at One Year Following Hematopoietic Cell Transplantation

Number of patients with no evidence of disease at one year following transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)78
Regimen B (UBCT)8

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Donor Chimerism CD3 at 100 Days Post Transplant

Number of patients with peripheral blood donor chimerism for CD3 less than 5%, 5-49%, 50-94% and greater than or equal to 95% at 100 days post transplant. (NCT00919503)
Timeframe: Day 100 post transplant

,
InterventionParticipants (Count of Participants)
Greater than equal to 95%50 - 94%5-49%Less than 5%
Regimen A (PBSCT and BMT)492960
Regimen B (UBCT)7211

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Overall Survival

Number of patients alive at 1 year following transplant (NCT00919503)
Timeframe: 1 year following transplant

InterventionParticipants (Count of Participants)
Regimen A (PBSCT and BMT)80
Regimen B (UBCT)9

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Donor Chimerism CD33 at Day 100 Post Transplant

Number of patients with peripheral blood donor chimerism for CD33 less than 5%, 5-49%, 50-94% and greater than or equal to 95% at 100 days post transplant. (NCT00919503)
Timeframe: 100 days post transplant

,
InterventionParticipants (Count of Participants)
Greater than equal to 95%50-94%5-49%Less than 5%
Regimen A (PBSCT and BMT)72840
Regimen B (UBCT)7221

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Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)

Acute GVHD is assessed according to the 1994 Consensus Conference Grading Criteria. Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. GVHD can affect performance status and attack multiple organ systems such as the skin, liver, gut, mouth, eyes, joints, lung, etc. that can lead to a rash, diarrhea, metabolic changes, infection and/or death. The clinical grading of acute GVHD is grade 0 (none) to 4 (severe). Chronic GVHD is a delayed form of GVHD that may occur after day 100 post transplant. (NCT00923364)
Timeframe: 2 years

Interventionparticipants (Number)
AcuteChronic
Recipients Only23

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Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)

Engraftment of donor cells was assessed using polymorphisms in regions known to contain short tandem repeats. Peripheral blood cluster of differentiation 14 (CD14+), cluster of differentiation 3 (CD3-)/cluster of differentiation 56 (CD56+), cluster of differentiation 19 (CD19+), and CD3+ subsets were isolated by flow cytometry and chimerism was assessed. (NCT00923364)
Timeframe: 2 years

Interventionpercentage of donor cells (Mean)
Donor CD14+ cells, %Donor CD19+ cells, %Donor CD3-/CD56+ cells, %Donor CD3+ cells, %
Recipients Only99.810099.897.6

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Days to Neutrophil Engraftment

Neutrophil engraftment is defined as a neutrophil count of >0.5 x 10(9) cells/L for 3 consecutive days. (NCT00923364)
Timeframe: 30 days

InterventionDays (Median)
Recipients Only12

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Days to Platelet Engraftment

Platelet engraftment is defined as a platelet count of >20 x 10(9) cells/L for 7 consecutive days without requiring a platelet transfusion. (NCT00923364)
Timeframe: 30 days

InterventionDays (Median)
Recipients Only30

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Number of Participants With Disease Free Survival

Number of participants with documented evidence of disease progression following start of treatment. (NCT00923364)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Recipients Only8

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Number of Participants With Serious and Non-serious Adverse Events

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00923364)
Timeframe: Date treatment consent signed to date off study, approximately, 91 months

InterventionParticipants (Count of Participants)
Recipients and Healthy Related Donors16

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Overall Survival

Overall survival is defined as date of on-study to date of death from any cause or last follow up. (NCT00923364)
Timeframe: 2 years

Interventionmonths (Median)
Recipients Only76

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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0).

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT00924326)
Timeframe: Date treatment consent signed to date off study, approximately 101 months and 17 days.

InterventionParticipants (Count of Participants)
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-28
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat1
0.5x10^7 Cells/kg2
2.5x10^6 Cells/kg5
1.0x10^6 Cells/kg6
1.0x10^6 Cells/kg (Reduced Chemo)7
2.0x10^6 Cells/kg (Reduced Chemo)10
6.0x10^6 Cells/kg (Reduced Chemo)1
2.0x10^6 Cells/kg (Moderate Chemo)2
2.0x10^6 Cells/kg (9-12 Days Culture)2

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Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma

Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00924326)
Timeframe: Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years

,,,,,,,,,
InterventionParticipants (Count of Participants)
Complete RemissionPartial RemissionStable DiseaseProgressive DiseaseNot Evaluable
0.5x10^7 Cells/kg20000
1.0x10^6 Cells/kg32001
1.0x10^6 Cells/kg (Reduced Chemo)23020
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-224101
1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat30000
2.0x10^6 Cells/kg (9-12 Days Culture)20000
2.0x10^6 Cells/kg (Moderate Chemo)20000
2.0x10^6 Cells/kg (Reduced Chemo)61120
2.5x10^6 Cells/kg30011
6.0x10^6 Cells/kg (Reduced Chemo)00010

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Percentage of Participants With Neutrophil Engraftment

Cumulative incidence of graft failure (neutrophil) by day 28 was reported. Patients who did not have neutrophil engraftment before death was considered as a competing risk. Failure to engraft was defined as lack of evidence of hematopoietic recovery (ANC <500/mm3 and platelet count < 20,000/mm3) by day +35, confirmed by a biopsy revealing a marrow cellularity < 5%. Graft failure was also defined as initial myeloid engraftment by day +35, documented to be of donor origin, followed by a drop in the ANC to < 500/mm3 for more than three days, independent of any myelosuppressive drugs, severe GVHD, CMV, or other infection. (NCT00943800)
Timeframe: Transplant (Day 0) through Day +28

Interventionpercentage of patients (Number)
Treatment Group85.1

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Overall Survival- Percentage of Participants Who Survived at 2 Years and 5 Years

We reported overall survival at 2 years and 5 years after transplant (NCT00943800)
Timeframe: up to 5 years

Interventionpercentage of patients (Number)
Two-year overall survivalFive-year overall survival
Treatment Group43.732.9

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Percentage of Participants With Incidence of Acute (Grade II-IV) and Chronic Graft-vs-host Disease(GVHD)

"Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).~Chronic GVHD is assessed by NIH consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. (See Citation: Filipovich AH et al)~The incidence of patients with acute GVHD (Grade II-IV) was determined at 180 days. The incidence of Chronic GVHD by 2 years was reported" (NCT00943800)
Timeframe: Up to 2 years

Interventionpercentage of patients (Number)
Acute GVHD (grade II-IV)Chronic GVHD
Treatment Group16.13.4

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Chronic Graft-Versus-Host Disease

Patients who developed chronic graft-versus-host disease. (NCT00963872)
Timeframe: Day 360

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose0
Complement Fragment A - Larger Cell Dose0

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Disease Progression

Patients who developed disease progression after transplantation. (NCT00963872)
Timeframe: Day 360

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose0
Complement Fragment A - Larger Cell Dose0

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Disease Progression

Patients who developed disease progression after transplantation. (NCT00963872)
Timeframe: Day 720

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose0
Complement Fragment A - Larger Cell Dose0

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Donor Chimerism

Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 100

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose90
Complement Fragment A - Larger Cell Dose94

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Donor Chimerism

Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 360

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose93
Complement Fragment A - Larger Cell Dose100

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Donor Chimerism in Blood

Percentage of donor DNA present in the peripheral blood (NCT00963872)
Timeframe: Day 60

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose91
Complement Fragment A - Larger Cell Dose97

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Incidence of Grades II-IV Graft-vs-host Disease

Development of graft-versus-host disease through day 100. (NCT00963872)
Timeframe: Day 0 through Day 100

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose8
Complement Fragment A - Larger Cell Dose1

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Incidence of Grades III-IV Graft-vs-host Disease

Development of graft-versus-host disease by day 100. (NCT00963872)
Timeframe: 0 to 100 days

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose2
Complement Fragment A - Larger Cell Dose0

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Neutrophil Engraftment

Achieving 500 neutrophils/uL by day 42. (NCT00963872)
Timeframe: Day 42

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose22
Complement Fragment A - Larger Cell Dose5

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Non-Relapse Mortality

Deaths not due to relapse. (NCT00963872)
Timeframe: Day 180

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose3
Complement Fragment A - Larger Cell Dose0

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Non-relapse Mortality

Deaths not due to relapse. (NCT00963872)
Timeframe: Day 360

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose3
Complement Fragment A - Larger Cell Dose0

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Number of Patients With the Complement 3a (C3a) Unit Predominating

Efficacy of the pre-incubation of one of two umbilical cord blood (UCB) units with C3a as part of a unrelated donor double UCB nonmyeloablative transplantation in patients with high-risk hematological malignancies. (NCT00963872)
Timeframe: Day 180

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose9
Complement Fragment A - Larger Cell Dose5

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Overall Survival

Survival (alive) from transplantation to last follow-up. (NCT00963872)
Timeframe: Day 360

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose14
Complement Fragment A - Larger Cell Dose5

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Overall Survival at Day 720

Survival (alive) from transplantation to last follow-up at day 720. (NCT00963872)
Timeframe: 720 days

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose13
Complement Fragment A - Larger Cell Dose5

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Platelet Recovery

Number of patients with >20,000 platelets/uL by day 180 (NCT00963872)
Timeframe: Day 180

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose19
Complement Fragment A - Larger Cell Dose5

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Donor Chimerism

Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 180

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose99
Complement Fragment A - Larger Cell Dose100

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Relapse of Disease

Patients who developed disease relapse after transplantation. (NCT00963872)
Timeframe: Day 360

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose10
Complement Fragment A - Larger Cell Dose0

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Relapse of Disease

Patients who developed disease relapse after transplantation. (NCT00963872)
Timeframe: Day 720

Interventionparticipants (Number)
Complement Fragment 3A - Small Cell Dose11
Complement Fragment A - Larger Cell Dose1

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Donor Chimerism in Blood

Percentage of donor DNA present in the peripheral blood (NCT00963872)
Timeframe: Day 28

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose92
Complement Fragment A - Larger Cell Dose96

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Bone Marrow Chimerism

Percentage of donor DNA in the bone marrow. (NCT00963872)
Timeframe: Day 21

Interventionpercentage of donor DNA (Mean)
Complement Fragment 3A - Small Cell Dose84
Complement Fragment A - Larger Cell Dose89

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Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease

"aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).~GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD." (NCT01008462)
Timeframe: 1 year post-allograft,

InterventionParticipants (Count of Participants)
Acute Graft-versus-Host-DiseaseChronic extensive Graft-versus-Host-Disease
Treatment (Autologous HCT, Donor HCT)81

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Event-Free Survival (EFS)

Number of patients surviving without relapsed/progressive disease (NCT01008462)
Timeframe: 1 Year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)9

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Number of Patients Who Engrafted

Number of patients with donor engraftment. (NCT01008462)
Timeframe: Day 84 post-allograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)13

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Number of Patients Who Had Infections

Number of patients who had infections. (NCT01008462)
Timeframe: 1 Year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)16

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Number of Patients With Relapsed/Progressive Disease

"Relapse/Progression defined as:~Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.~Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy ." (NCT01008462)
Timeframe: 1 year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)6

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Overall Survival

Number of patients surviving one year post-autograft (NCT01008462)
Timeframe: 1 year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)10

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Non-relapse Mortality (NRM)

Number of patients with non-relapse mortalities. (NCT01008462)
Timeframe: 200 days and 1 Year post-allograft

InterventionParticipants (Count of Participants)
200 days1 Year
Treatment (Autologous HCT, Donor HCT)01

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cGVHD

Chronic graft vs host disease (NCT01010217)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Haplo Arm11
1AgMM Related/Unrelated Donors7
MUD Donor0
Second Transplant0
Myelofibrosis0

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Disease Free Survival

Participants who have survived without their original disease. (NCT01010217)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Haplo Arm50
1AgMM Related/Unrelated Donors24
MUD Donor12
Second Transplant0
Myelofibrosis0

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Number of Participants With Non-relapse Mortality (NRM)

Non-relapse mortality (NRM) is defined as death from any cause other than relapse disease. Bayesian monitoring scheme described in Thall, Simon, and Estey (1996) employed to perform interim monitoring of the data during the course of the trial separately within each group. (NCT01010217)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Haplo Arm8
1AgMM Related/Unrelated Donors7
MUD Donor2
Second Transplant0
Myelofibrosis0

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Grade III-IV aGVHD

Acute Graft vs host disease (NCT01010217)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Haplo Arm11
1AgMM Related/Unrelated Donors7
MUD Donor1
Second Transplant0
Myelofibrosis0

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Engraftments

(NCT01010217)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Haplo Arm80
1AgMM Related/Unrelated Donors50
MUD Donor21
Second Transplant0
Myelofibrosis0

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Participants With a Complete Response

Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks. (NCT01019317)
Timeframe: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)

InterventionParticipants (Number)
Cytarabine + Fludarabine34

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2-year Progression-free Survival in Early Disease Participants

"Percentage of participants who were alive and progression free at 2 years for participants with early disease stage. The 2 year progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.~A progression is defined as one of the following events:~>= 50% increase in the products of at least two lymph nodes on two consecutive determinations two weeks apart (at least one lymph node must be >= 2 cm); appearance of new palpable lymph nodes.~>= 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin; appearance of palpable hepatomegaly or splenomegaly, which was not previously present.~> 50% increase in peripheral blood lymphocytes with an absolute increase > 5000/μL.~Transformation to a more aggressive histology (i.e., Richter's syndrome or prolymphocytic leukemia with >= 56% prolymphocytes)." (NCT01027000)
Timeframe: 2 years post-registration

Interventionpercentage of participants (Median)
Treatment (Combination of Chemotherapy and Transplant)79.5

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Number of Platelet Transfusions

Number platelet transfusions given to the patient between day 0 and day 100 post transplant (NCT01028716)
Timeframe: Day 0-100

Interventiontransfusions (Median)
Treatment (Nonmyeloablative HCT, TBI)6

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Non-relapse Mortality at 1 Year

Cumulative incidence of death without evidence of disease progression at 1 year (NCT01028716)
Timeframe: Up to 1 year

Interventionpercent of participants (Number)
Treatment (Nonmyeloablative HCT, TBI)22

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Incidence of Primary Graft Failure

Defined as < 5% donor CD3 chimerism. Chimerism will be measured by short tandem repeat-polymerase chain reaction on peripheral blood sorted into CD3 and CD33 cell fractions. (NCT01028716)
Timeframe: At day 84

InterventionParticipants (Count of Participants)
Treatment (Nonmyeloablative HCT, TBI)0

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Incidence of Grades III/IV Acute Graft Versus Host Disease

Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV. (NCT01028716)
Timeframe: At day 84

Interventionpercent (Number)
Treatment (Nonmyeloablative HCT, TBI)82

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Disease-free Survival

Defined as being alive and in remission by < 5% blasts by bone marrow morphology for patients with myeloid malignancies and CT or PET imaging for patients with lymphoid malignancies at the time of the assessment (NCT01028716)
Timeframe: 3 years from the date of transplant

Interventionpercent of participants (Number)
Treatment (Nonmyeloablative HCT, TBI)40

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Relapse of Malignancy After Transplantation

Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy. (NCT01028716)
Timeframe: Up to 7 years

Interventionpercent (Number)
Treatment (Nonmyeloablative HCT, TBI)29

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Percentage of Participants With Chronic Graft Versus Host Disease

Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years. (NCT01028716)
Timeframe: Up to 2 years post-transplant

Interventionpercentage of participants (Number)
Treatment (Nonmyeloablative HCT, TBI)26

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Toxicity of Treatment Regimen Determined by Number of Adverse Events Per Organ System

Assessed by Common Terminology Criteria for Adverse Events version 3.0. The incidence of all adverse events greater or equal to grade 3 was determined. (NCT01028716)
Timeframe: Up to day 90

Interventionevents (Number)
CardiacFeverRashGastrointestinalInfectionsCMV ReactivationFebrile NeutropeniaMetabolic/laboratoryMusculoskeletalNeurologicPainPulmonaryRenal/Genitourinary
Treatment (Nonmyeloablative HCT, TBI)139417552625243561010

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Time to Neutrophil Recovery

Achievement of an absolute neutrophil count greater or equal to 500/mm^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery. (NCT01028716)
Timeframe: Up to day 84 post-transplant

Interventiondays (Median)
Treatment (Nonmyeloablative HCT, TBI)16

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Number of Red Blood Cell Transfusions

Number of units of RBCs given to the patient between day 0 and day 100 post transplant (NCT01028716)
Timeframe: Day 0-100

Interventiontransfusions (Median)
Treatment (Nonmyeloablative HCT, TBI)8

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Time to Platelet Recovery

The first day of a sustained platelet count > 20,000/mm^3 with no platelet transfusions in the preceding seven days. (NCT01028716)
Timeframe: Up to day 84 post-transplant

Interventiondays (Median)
Treatment (Nonmyeloablative HCT, TBI)23

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Point Estimate of Overall Survival at 3 Years

Kaplan Meier estimate of the percentage of participants with overall survival at 3 years (NCT01028716)
Timeframe: 3 years

Interventionpercent (Number)
Treatment (Nonmyeloablative HCT, TBI)45.3

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Number of Participants With Grades II-IV Acute GVHD

Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria. (NCT01044745)
Timeframe: At day 100

InterventionParticipants (Count of Participants)
Treatment (Rituximab and Allogeneic HCT Transplant)16

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Event-free Survival

Estimated using Kaplan-Meier estimator. (NCT01044745)
Timeframe: From the date of transplant with relapse/progression or death as censored events, up to 2 years

Interventionmonths (Median)
Treatment (Rituximab and Allogeneic HCT Transplant)12

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Overall Survival

Estimated using Kaplan-Meier estimator. (NCT01044745)
Timeframe: From the date of transplant with death from any cause as a censored event, up to 2 years

Interventionmonths (Median)
Treatment (Rituximab and Allogeneic HCT Transplant)12

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To Measure the Incidence and Severity of Acute and Chronic GvHD

Population of participants that received HSCT and T-reg plus T-con, and developed actue, chronic, or any graft vs host disease (GvHD) (NCT01050764)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Acute GvHDChronic GvHDAny GvHD (actue + chronic)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)123

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Overall Survival (OS), 1 Year

Assessed as subjects remaining alive 12 months after CD34+ cell infusion (ie, excludes death due to any cause) (NCT01050764)
Timeframe: 1 year

InterventionParticipants (Number)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)2

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Median Overall Survival (OS)

Reported as the median overall survival (OS) in months from infusion of the hematopoietic stem cells (HSCT) (NCT01050764)
Timeframe: 25 months

Interventionmonths (Median)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)3.7

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Maximum-tolerated Dose (MTD) of Regulatory and Conventional T-cells

The maximum-tolerated dose (MTD) was to be determined based on the safety and feasibility observed for a pre-determined set of cellular dose level combinations of regulatory T-cells (T-reg) and conventional T-cells (T-con). (NCT01050764)
Timeframe: 30 days after HSCT infusion

Interventioncells/kg (Number)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)NA

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Acute Graft-versus-Host-Disease (aGvHD)

The primary outcome was incidence of grade 3 or 4 acute graft-vs-host-disease (aGvHD), reported as the number of participants developing grade 3 or 4 aGvHD. (NCT01050764)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)1

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Serious Infections

Serious infections are reported as the number of participants experienced serious infections. (NCT01050764)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)6

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Number of Participants With an Overall Response

Overall (OR) is the total number of participants with any response: Complete remission (CR), is defined as > 30% lymphocytes in the bone marrow, recovery of blood counts and no clinical symptoms; Nodular partial remission (NPR), is the same as CR but with nodules; Partial remission (PR) is > 50% decrease of clinical symptoms from baseline and recovery from blood counts. (NCT01082939)
Timeframe: 6 cycles of treatment (28 days per cycle)

InterventionParticipants (Number)
Complete remission (CR)Nodular partial remission (NPR)Partial remission (PR)
CFAR23326

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Overall Response Rate of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)

Overall Response is Complete response (CR) + Partial response (PR). Overall response evaluated by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 for complete or partial response and progressive disease. Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts; (NCT01096992)
Timeframe: Overall response assessed 2 months after 6th or last course if participants not able to receive all 6 intended courses of treatment.

InterventionParticipants (Count of Participants)
Phase 1 20 mg/m^25
Phase 1 30 mg/m^23
Phase 1 40 mg/m^25
Phase 1 50 mg/m^22
Phase 217

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Maximum Tolerated Dose (MTD) of Bendamustine Combined With Fixed-Dose Fludarabine and Rituximab (FBR)

MTD defined as highest dose level in which 6 participants have been treated with /= 3 non-hematologic toxicity. Hematologic toxicity grade >/= 3 that lasts longer than 42 days considered a DLT. Hematologic toxicity graded according to the 2008 IWCLL criteria for grading. Tumor lysis not considered a DLT. (NCT01096992)
Timeframe: After 4 week cycle

Interventionmg/m^2 (Number)
Phase 130

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Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)

(NCT01131169)
Timeframe: 2 years

InterventionProportion of participants PFS (Number)
Relapsed Multiple Myeloma0.31

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Proportion of Participants With Relapsed Multiple Myeloma Alive at 2 Years

(NCT01131169)
Timeframe: 2 years

InterventionProportion of pts alive at 2 years (Number)
Relapsed Multiple Myeloma0.54

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Progression Free Survival Rate 2 Years After Initiation of Induction Therapy

"Death or disease progression defined by the 2008 IWCLL guideline as follows;~Greater than or equal to 50% increase in the SPD of at least 2 lymph nodes (at least one node must be greater than or equal to 2 cm); appearance of any new lymph nodes on physical examination or imaging~Greater than or equal to 50% increase in the size of the liver and/or spleen as determined by measurement below the respective costal margin or CT scan or appearance of palpable hepatomegaly or splenomegaly, which was not previously present~Greater than or equal to 50% increase in the absolute number of circulating lymphocytes to at least 5000/ul~Transformation to a more aggressive histology~Occurrence of any cytopenia attributable to CLL. After treatment: the progression of any cytopenia (unrelated to autoimmune cytopenia), as documented by a decrease of Hb levels by more than 20 g/L (2 g/dL) or to less than 100 g/L (10 g/dL), or by a decrease of platelet counts by more than 50% or to les" (NCT01145209)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
FO Arm14
FCO Arm9

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Participants With MRD Negativity at the Completion of Consolidation Immunotherapy Who Failed to Achieve MRD Negativity

Participants with MRD negativity at the completion of consolidation immunotherapy who failed to achieve MRD negativity following completion of induction chemoimmunotherapy (NCT01145209)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
FO Arm14
FCO Arm4

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Participants With Minimal Residual Disease (MRD) Negativity

Participants with minimal residual disease (MRD) negativity following the completion of induction chemoimmunotherapy. (NCT01145209)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
FO ARM4
FCO ARM6

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Participants With Complete Response Rates Following Induction Chemoimmunotherapy.

"Participants with complete response rates to induction chemoimmunotherapy.~Criteria for complete response (CR): CR requires all of the following:~Peripheral blood lymphocytes < 4000/uL~Absence of significant lymphadenopathy by physical examination and appropriate radiographic techniques (CT or MRI). All lymph nodes must have regressed to <=1.5cm in greatest diameter~Absence of hepatomegaly or splenomegaly by physical examination, or appropriate radiographic techniques. Spleen, if enlarged before therapy must have regressed in size and must not be palpable by physical exam.~Absence of constitutional symptoms~Normal CBC, defined as: - Polymorphonuclear cells ≥ 1,500/uL - Platelets > 100,000/uL (untransfused) - Hemoglobin > 11 g/dL (untransfused)~Bone marrow biopsy demonstrates normal cellularity for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent" (NCT01145209)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
FCO Arms6
FO Arm2

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Median Relationship of CD20 Expression With MRD Negativity Rate

Median relationship of biomarker, CD20 expression with MRD negativity clinical response rate. Flow cytometry was use to quantified surface CD20 on peripheral blood. (NCT01145209)
Timeframe: 2 years

Interventionsites per cell (Median)
Minimal Residual Disease (MRD) Positivity10247
Minimal Residual Disease (MRD) Negativity15131

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100-day Mortality

The number of death reported within the first 100 days after transplant. (NCT01168219)
Timeframe: Up to 100 days post-treatment

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Transplant)10

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Overall Survival (OS)

Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator. (NCT01168219)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
OS at 2 yearsOS at 5 years
Treatment (Chemotherapy and Transplant)45.731.2

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Progression-free Survival

"Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively.~AML progression is defined as:~Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow~If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts~Development of extramedullary leukemia MDS progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate" (NCT01168219)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
PFS at 2 yearsPFS at 5 years
Treatment (Chemotherapy and Transplant)41.226.9

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Relapse Rate (RR) Following Transplantation at 2-year.

Percentage of participants Relapse Rates (RR) following transplantation at 2-year. (NCT01203020)
Timeframe: At 2 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant39.7

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Non-Relapse Mortality (NRM) Following RTC Transplantation at 2 Years.

Percentage of participants NRM following RTC transplantation at 2-year. (NCT01203020)
Timeframe: At 2 years

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant24.6

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Non-Relapse Mortality (NRM) Following RTC Transplantation at 1 Year.

Percentage of participants NRM following RTC transplantation at 1-year. (NCT01203020)
Timeframe: At 1 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant17.1

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Relapse Rate (RR) Following Transplantation at 1-year.

Percentage of participants Relapse Rates (RR) following transplantation at 1-year. (NCT01203020)
Timeframe: At 1 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant28.7

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Percentage of 1-year Progression Free Survival (PFS)

Percentage of 1-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine. (NCT01203020)
Timeframe: At 1 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant59.1

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Percentage of 2-year Progression Free Survival (PFS)

Percentage of 2-year progression free survival (PFS) of patients with chemotherapy refractory Hodgkin's and non-Hodgkin's lymphoma (NHL) undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex and fludarabine. (NCT01203020)
Timeframe: At 2 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant45.5

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Percentage of 2 Year Overall Survival (OS)

Percentage of participants-- 2 Year Overall Survival (OS) post transplant (NCT01203020)
Timeframe: At 2nd year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant59.1

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Rates of Acute and Chronic Graft Versus Host Disease (GVHD).

Count/Percentage rates of acute and chronic graft versus host disease (GVHD). (NCT01203020)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Acute GVHDChronic GVHD
Allogeneic Hematopoietic Progenitor Cell Transplant53

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Percentage of 1 Year Overall Survival (OS)

Percentage of participants--1 year overall survival (OS) following transplantation. (NCT01203020)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Allogeneic Hematopoietic Progenitor Cell Transplant63.6

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Number of Patients With Grades III-IV Acute GVHD

"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01231412)
Timeframe: Up to 100 days

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)8
Arm II (MMF, CSP, and Sirolimus)2
Arm 0 (CSP and Sirolimus)0

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Number of of Participants Surviving Overall

Number of subjects surviving overall post-transplant. (NCT01231412)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)53
Arm II (MMF, CSP, and Sirolimus)75
Arm 0 (CSP and Sirolimus)6

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Number of Patients With Chronic Extensive GVHD

Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. (NCT01231412)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)38
Arm II (MMF, CSP, and Sirolimus)43
Arm 0 (CSP and Sirolimus)3

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Number of Non-Relapse Mortalities

Number of subjects expired without disease progression/relapse. (NCT01231412)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)12
Arm II (MMF, CSP, and Sirolimus)4
Arm 0 (CSP and Sirolimus)0

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Number of Participants With Relapse/Progression

"Relapse/Progression criteria:~CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever >38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or numb" (NCT01231412)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)16
Arm II (MMF, CSP, and Sirolimus)16
Arm 0 (CSP and Sirolimus)1

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Number of Patients With Grades II-IV Acute GVHD

"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01231412)
Timeframe: At day 100 post-transplant

InterventionParticipants (Count of Participants)
Arm I (MMF and CSP)39
Arm II (MMF, CSP, and Sirolimus)22
Arm 0 (CSP and Sirolimus)3

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Number of Non-Relapse Mortalities

Number of patients expired without disease progression/relapse. (NCT01251575)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Treatment (Fludarabine, Transplant, Immunosuppression)3

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Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)

"Number of patients with grades II-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01251575)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Class I Mismatch15
Class II Mismatch12

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Number of Patients With Grade III-IV Acute GVHD

"Number of patients with grades III-IV acute GVHD~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01251575)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Treatment (Fludarabine, Transplant, Immunosuppression)2

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Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: At 3 years after CR

Interventionpercentage of patients (Number)
Treatment (Chemotherapy, Transplant)52.6

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Disease Free Survival (DFS)

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years

InterventionMonths (Median)
Treatment (Chemotherapy, Transplant)29.7

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Response

Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) >1000/μL, no circulating blasts, platelets >100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and <5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT01256398)
Timeframe: 10 years

Interventionproportion of participants (Number)
Treatment (Chemotherapy, Transplant).9846

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Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)

Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years

Interventionproportion of participants (Number)
Treatment (Chemotherapy, Transplant)0.667

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Overall Survival (OS)

Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years

InterventionMonths (Median)
Treatment (Chemotherapy, Transplant)55.9

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Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.

Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Transplant)5

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Achievement of Remission

"Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease." (NCT01300572)
Timeframe: 4 weeks after transplant

InterventionParticipants (Count of Participants)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)13

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Rates of Engraftment

Average number of days to ANC >= 500 after transplant (NCT01300572)
Timeframe: Up to 84 days post-transplant

Interventiondays (Mean)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)16

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Rates of Donor Chimerism

Number of participants who has 100% donor chimerism within 100 days after transplant (NCT01300572)
Timeframe: Up to 100 days post-transplant

InterventionParticipants (Count of Participants)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)14

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The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.

The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached. (NCT01300572)
Timeframe: Within the first 30 days following transplant

InterventionGy (Number)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)28

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Disease-free Survival

Number of study participants who are alive and remains in complete remission after transplant. (NCT01300572)
Timeframe: 100 days after transplant

Interventionparticipants (Number)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)7

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Rates of Non-relapse Mortality

Transplant-related deaths within 100 days after transplant (NCT01300572)
Timeframe: Within the first 100 days following transplant

InterventionParticipants (Count of Participants)
Severe refractory GVHDBacterial infection
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)11

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Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor

The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight. (NCT01300572)
Timeframe: Approximately day -20 to day -12 prior to transplant

InterventionGy (Mean)
Average absorbed dose to the marrowAverage absorbed dose to the liverAverage abosorbed dose total bodyAverage absorbed dose to the spleen
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)11.417.23.170

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Duration of Remission

"Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following:~Normal bone marrow with blasts <5% with normal cellularity, normal megakaryopoiesis, > 15% erythropoiesis and > 25% granulocytopoiesis~Normalization of blood counts (no blasts, platelets > 100000/mm3, granulocytes >1500/mm3)~No extramedullary disease.~Relapse Criteria:~After CR: >5% blasts in the bone marrow and/or peripheral blood~After partial remission (PR): increase of blasts cells in the marrow to >50% of those during PR~Extramedullary disease confirmed cytologically or histologically." (NCT01300572)
Timeframe: 1 year

Interventiondays (Median)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)213

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Overall Survival

Number of participants who are still alive after transplant with or without disease. (NCT01300572)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)7

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Treatment Outcome and Percent Change in Tumor Volume

Measurement of tumor response to study drug, as measured by the percentage of change in tumor volume as measured by a physicial measurement using a ruler (NCT01310179)
Timeframe: Entry through Study Day 56

Interventionparticipants (Number)
Progression (>+20%)Stable (+20% to -30%)Partial Response (>-30%)
Ad/PNP and Fludarabine Monophosphate255

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Number of Participants With Side Effects After Ad/PNP-F-araAMP Treatment

Number of participants who had the most frequently observed undesirable effects after exposure to study drug (NCT01310179)
Timeframe: Entry through Study Day 56

Interventionparticipants (Number)
injection site symptomsfatiguefacial painnausea
Ad/PNP and Fludarabine Monophosphate12885

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Number of Participants With Primary Graft Failure

Primary graft failure is defined by lack of neutrophil engraftment. (NCT01339910)
Timeframe: 28 days post-transplant

InterventionParticipants (Count of Participants)
Myeloablative Conditioning Regimen (MAC)1
Reduced Intensity Conditioning (RIC)3

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Percentage of Participants With Chronic GVHD

Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. (NCT01339910)
Timeframe: 18 months post-transplant

Interventionpercentage (Number)
Myeloablative Conditioning Regimen (MAC)64.0
Reduced Intensity Conditioning (RIC)47.6

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Percentage of Participants With Disease Relapse

Disease Relapse is defined as relapse of the primary disease. (NCT01339910)
Timeframe: 18 months post-randomization

Interventionpercentage (Number)
Myeloablative Conditioning Regimen (MAC)13.5
Reduced Intensity Conditioning (RIC)48.3

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Percentage of Participants With Relapse-Free Survival (RFS)

Relapse-free survival is defined as survival without relapse of the primary disease. (NCT01339910)
Timeframe: 18 months post-randomization

Interventionpercentage (Number)
Myeloablative Conditioning Regimen (MAC)67.8
Reduced Intensity Conditioning (RIC)47.3

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Number of Participants With Donor Cell Engraftment

Donor cell engraftment will be assessed by donor-recipient chimerism assays. Full donor chimerism is defined as the presence of at least 95% donor cells as a proportion of the total population in the peripheral blood or bone marrow. Graft rejection is defined as the presence of no more than 5% donor cells as a proportion of the total population. Mixed chimerism is defined as the presence of between 5% and 95% donor cells. Mixed or full donor chimerism will be considered evidence of donor engraftment. (NCT01339910)
Timeframe: Days 28 and 100 and 18 months post-transplant

InterventionParticipants (Count of Participants)
Day 2872548419Day 2872548420Day 10072548420Day 1007254841918 Months7254842018 Months72548419
Mixed ChimerismFull Donor ChimerismGraft RejectionDeath Prior to AssessmentUnknown (relapsed or missing assay)
Myeloablative Conditioning Regimen (MAC)86
Reduced Intensity Conditioning (RIC)80
Myeloablative Conditioning Regimen (MAC)9
Reduced Intensity Conditioning (RIC)30
Myeloablative Conditioning Regimen (MAC)1
Myeloablative Conditioning Regimen (MAC)0
Reduced Intensity Conditioning (RIC)0
Myeloablative Conditioning Regimen (MAC)36
Reduced Intensity Conditioning (RIC)22
Myeloablative Conditioning Regimen (MAC)106
Reduced Intensity Conditioning (RIC)86
Myeloablative Conditioning Regimen (MAC)12
Myeloablative Conditioning Regimen (MAC)2
Myeloablative Conditioning Regimen (MAC)6
Reduced Intensity Conditioning (RIC)8
Myeloablative Conditioning Regimen (MAC)71
Reduced Intensity Conditioning (RIC)66
Myeloablative Conditioning Regimen (MAC)4
Reduced Intensity Conditioning (RIC)5
Reduced Intensity Conditioning (RIC)1
Myeloablative Conditioning Regimen (MAC)31
Reduced Intensity Conditioning (RIC)42
Myeloablative Conditioning Regimen (MAC)25
Reduced Intensity Conditioning (RIC)19

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Number of Participants With Secondary Graft Failure

Secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in neutrophil counts to less than 500x10^6/liter that is unresponsive to growth factor therapy. (NCT01339910)
Timeframe: 18 months post-transplant

InterventionParticipants (Count of Participants)
Myeloablative Conditioning Regimen (MAC)1
Reduced Intensity Conditioning (RIC)4

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Percentage of Participants With Acute Graft Versus Host Disease (GVHD)

"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT01339910)
Timeframe: Day 100 post-transplant

,
Interventionpercentage (Number)
Grade II-IV Acute GVHDGrade III-IV Acute GVHD
Myeloablative Conditioning Regimen (MAC)44.713.6
Reduced Intensity Conditioning (RIC)31.66.8

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Percentage of Participants With Neutrophil and Platelet Engraftment

Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for 3 consecutive measurements on different days. The first of the 3 days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 20,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days. (NCT01339910)
Timeframe: Days 28 and 60 post-transplant

,
Interventionpercentage (Number)
Neutrophil Engraftment at Day 28Platelet Engraftment at Day 60
Myeloablative Conditioning Regimen (MAC)98.595.5
Reduced Intensity Conditioning (RIC)97.896.2

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Percentage of Participants With Overall Survival (OS)

Overall survival is defined as survival of death from any cause. (NCT01339910)
Timeframe: 18 months post-randomization

Interventionpercentage (Number)
Myeloablative Conditioning Regimen (MAC)77.5
Reduced Intensity Conditioning (RIC)67.7

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To Compare the Relapse Rate at 1 Year of Patients With Myeloid Malignancies Receiving Each Treatment

(NCT01366612)
Timeframe: 1 year

InterventionPercent (Number)
Group 138.9
Group 218.8

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Number of Participants With Molecular Complete Remission at 3 Month Post Transplant

Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion. (NCT01390402)
Timeframe: Baseline to up to 4 months post-transplant

Interventionparticipants (Number)
NK Infusion + Chemotherapy3

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Chimerism

Donor T-cell and myeloid chimerism will be described separately by conditioning regimen intensity (myeloablative or reduced intensity) according to proportions with mixed chimerism (5-95% donor cells out of all), full chimerism (>95% donor cells), or graft rejection (<5% donor cells). (NCT01410344)
Timeframe: Week 4, Day 100, and 6 months Post-transplant

InterventionParticipants (Count of Participants)
Week 472365409Week 472365410Day 10072365410Day 100723654096 Months723654096 Months72365410
Graft RejectionNo Assay ReportedFull ChimerismMixed ChimerismDead at Assessment
Reduced Intensity Allogeneic Transplant4
Myeloablative Allogeneic Transplant1
Myeloablative Allogeneic Transplant3
Myeloablative Allogeneic Transplant4
Reduced Intensity Allogeneic Transplant5
Myeloablative Allogeneic Transplant2
Reduced Intensity Allogeneic Transplant2
Myeloablative Allogeneic Transplant0
Reduced Intensity Allogeneic Transplant0

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Percentage of Participants With Overall Survival

Overall survival is defined as the time from transplant to death from any cause. (NCT01410344)
Timeframe: Six months, 1 Year, and 2 Years Post-transplant

Interventionpercentage of participants (Number)
6 Months1 Year2 Years
Allogeneic Transplant82.458.850.2

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Percentage of Participants With Non-Relapse Mortality

The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy. (NCT01410344)
Timeframe: Day 100, 1 Year, and 2 Years Post-transplant

Interventionpercentage of participants (Number)
Day 1001 Year2 Years
Allogeneic Transplant0.011.818.3

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Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD)

Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. (NCT01410344)
Timeframe: 1 Year Post-transplant

Interventionpercentage of participants (Number)
Allogeneic Transplant17.6

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Percentage of Participants With Relapse/Progression

Relapse/Progression is defined as relapse or progression of the primary malignancy. (NCT01410344)
Timeframe: 1 Year Post-transplant

Interventionpercentage of participants (Number)
Allogeneic Transplant29.4

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Percentage of Participants Recovering Hematologic Function

Recovery of hematologic function is described by the time to neutrophil and platelet recovery. Time to neutrophil recovery will be the first of three consecutive days of > 500 neutrophils/μL following the expected nadir. Time to platelet engraftment will be described by the date when platelet count is > 20,000/μL for the first of three consecutive labs with no platelet transfusions 7 days prior. (NCT01410344)
Timeframe: Days 28 and 100 Post-transplant

Interventionpercentage of participants (Number)
Day 28 Neutrophil RecoveryDay 100 Platelet Recovery
Allogeneic Transplant100.094.1

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Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD)

"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4" (NCT01410344)
Timeframe: Day 100 Post-transplant

Interventionpercentage of participants (Number)
Grade II-IV Acute GVHDGrade III-IV Acute GVHD
Allogeneic Transplant41.211.8

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Grades II-IV and III-IV Acute GVHD

Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots. (NCT01427881)
Timeframe: Through day +100 post-transplant

Interventionpercentage of patients (Number)
Grades II-IV GVHDGrades III-IV GVHD
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)770

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Persistent or Recurrent Malignancy After HCT

Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation. (NCT01427881)
Timeframe: At 2 years

Interventionpercentage of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)17

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Overall Survival

Overall survival will be evaluated as Kaplan-Meier estimates. (NCT01427881)
Timeframe: At 1 year post-transplant

Interventionpercentage of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)75.6

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Chronic GVHD Requiring Systemic Immunosuppressive Treatment

Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from ~35% to ~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error. (NCT01427881)
Timeframe: At 1 year after transplantation

Interventionpercent of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)16

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Hematologic Recovery

Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is > 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is >= 20,000/uL without platelet transfusion support in the seven days prior. (NCT01427881)
Timeframe: Up to day +100

Interventiondays (Median)
Neutrophil EngraftmentPlatelet Engraftment
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)1914

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Disease-free Survival

Disease-free survival will be evaluated as Kaplan-Meier estimates. (NCT01427881)
Timeframe: At 1 year post-transplant

Interventionpercentage of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)73.8

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Donor Engraftment

Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood. (NCT01427881)
Timeframe: At day 28

InterventionParticipants (Count of Participants)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)6

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Graft Failure

Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of >= 500/uL by >= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to < 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors. (NCT01427881)
Timeframe: By greater than or equal to 28 days post-transplant

Interventionpercentage of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)2

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Non-relapse Mortality

Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence. (NCT01427881)
Timeframe: At 2 years

Interventionpercentage of patients (Number)
Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)14

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Overall Survival

(NCT01434472)
Timeframe: Up to 2 years post transplant

InterventionParticipants (Count of Participants)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)14

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Progression-free Survival

Based on a one-sample chi-square test with one-sided significance level of five percent. This study will be deemed successful if the 1 year progression-free survival of this highest-risk group of patients is 54% or greater. (NCT01434472)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)11

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Absolute Neutrophil Count (ANC) Engraftment

The median time in days to achieve ANC recovery defined as ANC>500uL. (NCT01434472)
Timeframe: Up to day 100

InterventionDays (Median)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)16

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Hematopoietic Toxicity

Clinical sequelae due to hematopoietic toxicity as defined by incidences of neutropenic fever and bleeding. (NCT01434472)
Timeframe: Up to day 100

InterventionIncidences (Number)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)5

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Response Rates

Response is defined as having achieved a Partial Response or better. (NCT01434472)
Timeframe: Day 100

InterventionParticipants (Count of Participants)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)16

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Platelet Engraftment

The median time in days to achieve platelet recovery as defined as platelet >20,000uL. (NCT01434472)
Timeframe: Up to day 100

InterventionDays (Median)
Treatment (Radiolabeled Antibody, TBI, Allogeneic PBSCT)9

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Overall Response Rate

"Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria.~International Myeloma Working Group Response Criteria for Multiple Myeloma:~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease" (NCT01453101)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Fludarabine, Melphalan, Bortezomib45

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Progression Free Survival

The main primary endpoint of this study is two-year progression free survival. Patients are considered a failure with respect to PFS if they die or experience disease progression or relapse. The time to this event is the time from transplantation to relapse/progression, initiation of non-protocol anti-myeloma therapy, or death from any cause. Subjects alive without confirmed disease progression will be censored at the time of last disease evaluation. Deaths without progression are treated as failures no matter when they occur. (NCT01453101)
Timeframe: Subjects will be followed for progression-free survival for at least 36 months

InterventionMonths (Median)
Fludarabine, Melphalan, Bortezomib16.7

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Overall Survival (OS)

Overall survival (OS): Defined as time from the first dose of administration to death from any cause (NCT01453101)
Timeframe: Up to 3 years

Interventionpercentage (Number)
Fludarabine, Melphalan, Bortezomib42

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Number of Participants With Non Relapse Mortality at 100 Day Post Transplant

Number of participants expired from complications other than relapsed disease at 100 day Post Transplant. (NCT01471444)
Timeframe: 100 day Post Transplant

InterventionParticipants (Count of Participants)
Arm A (Flu+Bu)3
Arm B (Flu+Clo+Bu)6

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Progression-Free Survival (PFS)

Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant. (NCT01471444)
Timeframe: From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years

InterventionNumber of events (Number)
Arm A (Flu+Bu)69
Arm B (Flu+Clo+Bu)61

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Overall Survival (OS) Post Transplant at 1, 3 and 5 Years

Number of participants in the study who are alive and disease free at 1, 3 and 5 years post transplant. (NCT01471444)
Timeframe: Post transplant after 1, 3 and 5 years

,
InterventionParticipants (Count of Participants)
1 Year Post Transplant3 Year Post Transplant5 Year Post Transplant
Arm A (Flu+Bu)836964
Arm B (Flu+Clo+Bu)826963

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Number of Participants in the Study Who Are With no Grade 3 or 4 Acute Graft-versus-host Disease at Any Time During the First 100 Days Post Transplant.

Number of participants in the study who are with no Grade 3 or 4 acute graft-versus-host disease at any time during the first 100 days post transplant. (NCT01471444)
Timeframe: 100 days post transplant

InterventionParticipants (Count of Participants)
Arm A (Flu+Bu)125
Arm B (Flu+Clo+Bu)115

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Overall Survival (OS)

Percentage of participants alive at 3 years. (NCT01490723)
Timeframe: From date of treatment to date of relapse or death, up to 3 years

InterventionParticipants (Count of Participants)
Yttrium-90 Ibritumomab + Chemo14

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Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).

Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant. (NCT01499147)
Timeframe: Up to 100 days post-transplant (acute GVHD).

Interventionparticipants (Number)
Fludarabine/Busulfan + ATG2
Fludarabine/Melphalan +ATG1

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Number of Participants With Engraftment.

Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant. (NCT01499147)
Timeframe: Up to 30 days post-transplant

Interventionparticipants (Number)
Fludarabine/Busulfan + ATG18
Fludarabine/Melphalan + ATG12

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Time to ANC and Platelet Engraftment

Days to ANC or platelet engraftment (NCT01499147)
Timeframe: Up to 30 days post-transplant

Interventiondays to ANC and platelet engraftment (Median)
Fludarabine/Busulfan + ATG15
Fludarabine/Melphalan + ATG12

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Overall Survival (OS)

Overall Survival is defined as the interval between day of transplant and day of death. (NCT01518153)
Timeframe: Every 3 months until day of death

Interventiondays (Median)
Stem Cell Transplant + Donor Lymphocyte Infusion246

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Success Rate

Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI). (NCT01518153)
Timeframe: 100 days

Interventionparticipants (Number)
Low Dose Donor T-Cells1
High Dose Donor T-Cells3

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Number of Patients With Recurrent or Progressive Malignancy

"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions." (NCT01527045)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)7
Primary - Reg B (TBI Alone)4
Adjunct3

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Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant

"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01527045)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)2
Primary - Reg B (TBI Alone)0
Adjunct0

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Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)

"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death" (NCT01527045)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)15
Primary - Reg B (TBI Alone)2
Adjunct6

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Number of Donors Discontinuing Atorvastatin Due to Toxicity

"The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events:~Musculoskeletal and connective tissue disorders: grade 2-5~Hepatobiliary disorders: grade 2-5~Other unexpected events thought related to the use of atorvastatin; grade 2-5~In cases where the NCI criteria do not apply, intensity will be defined as:~Mild: awareness of symptom or sign, but easily tolerated~Moderate: discomfort is enough to cause interference with normal activities~Severe: inability to perform normal daily activities~Life threatening: immediate risk of death from the reaction as it occurred" (NCT01527045)
Timeframe: Prior to stem cell collection

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)2
Primary - Reg B (TBI Alone)0
Adjunct1

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Number of Non-relapse Mortalities

Number of patients who died without relapsed/progressive disease. (NCT01527045)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)4
Primary - Reg B (TBI Alone)1
Adjunct0

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Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy

Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy. (NCT01527045)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)23
Primary - Reg B (TBI Alone)3
Adjunct4

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Number of Patients Surviving Overall

Number of patients surviving overall post-transplant (NCT01527045)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)21
Primary - Reg B (TBI Alone)3
Adjunct9

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Number of Patients With Chronic Extensive GVHD

Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines. (NCT01527045)
Timeframe: 1 Year post-transplant

InterventionParticipants (Count of Participants)
Primary - Reg A (Flu/TBI)8
Primary - Reg B (TBI Alone)1
Adjunct5

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Clinical Response

"Patients will be followed according to response criteria as referenced in BMT SOP Standards of Therapy last updated 2008. Clinical Response = CR + PR.~Complete Response Requires all of the following:~Serum and urine negative for monoclonal proteins by immunofixation~Normal free light chain ratio~Plasma cells in marrow < 5%~Partial Response (PR) Requires any of the following:~- ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL~Progressive Disease (PD) Requires any of the following:~If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)~If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.~Free light chain increase of ≥ 50% to" (NCT01529827)
Timeframe: In the first 100 days from day 0 of transplant

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic PBSCT)45

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Median Time to Neutrophil Engraftment

Median time to recovery of absolute neutrophil count >=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals. (NCT01529827)
Timeframe: Day 100

Interventiondays (Median)
Treatment (Reduced Intensity Allogeneic PBSCT)17

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Progression Free Survival (PFS) at One Year

Assessed using Kaplan Meier and Proportional Hazards (NCT01529827)
Timeframe: day of transplant until progression up to 5 years

Interventionpercentage of participants (Number)
Treatment (Reduced Intensity Allogeneic PBSCT)85

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Disease Activity

Evaluated using a standardized tool for evaluating CD (CDAI). (NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)0

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Incidence of Graft Rejection

Engraftment is defined as achieving > 5% donor peripheral blood CD3 T cell chimerism by day 84 after HCT. Primary graft failure is defined as a donor peripheral blood CD3 T cell chimerism peak of < 5% by Day 84 post-HCT. Secondary graft failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood CD3 T cell chimerism < 5% as demonstrated by a chimerism assay. (NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)0

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Overall Survival

Characterized by the event rates as functions of all patients enrolled and at risk of the event, with exact confidence intervals. (NCT01570348)
Timeframe: Time of treatment assignment until death due to any cause, assessed up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)1

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Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire

(NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)0

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Incidence of Disease-modifying Drugs for CD Initiated Post-transplant

Includes the administration of any therapy (drugs, biologics, or any other treatments) clearly given as immunomodulatory therapy for underlying CD. (NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)0

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Incidence and Severity of GVHD

The grading of acute and chronic GVHD will follow previously published guidelines but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and CD involve the gastrointestinal tract, all diagnostic biopsies of these organs will be reviewed by pathologists experienced in the diagnosis of GVHD and IBD, respectively. (NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)1

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EFS

Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals. (NCT01570348)
Timeframe: Up to 5 years post-transplant

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)1

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Development of Infectious Complications

The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient. (NCT01570348)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)1

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Event-free Survival (EFS)

Defined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals. (NCT01570348)
Timeframe: At 1 year post-transplant

InterventionParticipants (Count of Participants)
Treatment (Allogeneic BMT)1

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Non-Relapse Mortality Rate (NRM)

Number of participants expired within the first 100 days after transplant not due to relapsed disease. (NCT01572662)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l2
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.8

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Overall Survival

Number of participants that were diseased free and alive 3 years post-transplant. (NCT01572662)
Timeframe: Up to 3 years post-transplant

InterventionParticipants (Count of Participants)
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l16
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.47

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Overall Survival

Number of participants that are disease free and alive one year post transplant. (NCT01572662)
Timeframe: Up to 1 year post-transplant

InterventionParticipants (Count of Participants)
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l29
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.93

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Maintenance of T Cell Receptor (TCR) Expression of Transduced T Cells (Arm I) i.e. Persistence

(NCT01640301)
Timeframe: Up to 28 days post intervention per patient

InterventionParticipants (Count of Participants)
Group 1 (Avelumab and MHC Class I Up-regulation)12

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Maintenance of Function of Transduced T Cells (Arm I)

(NCT01640301)
Timeframe: Up to 28 days post intervention per patient

InterventionParticipants (Count of Participants)
Group 1 (Avelumab and MHC Class I Up-regulation)9

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Incidence of Relapse After T Cell Therapy (Arm II)

(NCT01640301)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)9

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Disease-free Survival After T Cell Therapy

(NCT01640301)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Arm I (High-risk for Relapse After HCT)13
Arm II (Relapsed After HCT)7

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Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)

(NCT01640301)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Group 1 (Avelumab and MHC Class I Up-regulation)1

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Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)

(NCT01640301)
Timeframe: Up to 1 year following infusion per patient

InterventionParticipants (Count of Participants)
Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)0

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Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)

(NCT01640301)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)8

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Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)

(NCT01640301)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Group 1 (Avelumab and MHC Class I Up-regulation)6

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Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)

"Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response:~Complete Response (CR) = Bone Marrow blasts <5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent.~Platelets ≥ 100,000/μl Absolute neutrophil count >1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery)~Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery)~Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for >4 weeks." (NCT01640301)
Timeframe: Up to 1 year

Interventiondays (Median)
Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)28

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Overall Survival

(NCT01690520)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Standard of Care)52
Arm II (Experimental)57

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Proportion of Participants With Chronic Graft Versus Host Disease

(NCT01690520)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Standard of Care)27
Arm II (Experimental)23

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Time to Platelet Engraftment (20k)

First day of seven consecutive days with platelet count equal to or greater than 20,000 cells/microliter without platelet transfusions measured from day of transplant. (NCT01690520)
Timeframe: Up to 100 days post-transplant

Interventiondays (Median)
Arm I (Standard of Care)40.0
Arm II (Experimental)38.0

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Time to Neutrophil Engraftment

First of two consecutive days with absolute neutrophil count (ANC) equal to or greater than 500 cell/microliter measured from day of transplant. (NCT01690520)
Timeframe: Up to 55 days post-transplant

Interventiondays (Median)
Arm I (Standard of Care)20.0
Arm II (Experimental)22.0

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Proportion of Patients With Severe Acute Graft Versus Host Disease

(NCT01690520)
Timeframe: Up to 100 days post-transplant

Interventionproportion of participants (Number)
Arm I (Standard of Care)0.14
Arm II (Experimental)0.16

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Non-relapse Mortality

(NCT01690520)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Arm I (Standard of Care)16
Arm II (Experimental)16

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Overall Survival (OS)

Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals. (NCT01707004)
Timeframe: Day 100

Interventionpercentage of participants (Number)
Decitabine + Bone Marrow Transplant64.7

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Number of Participants With Primary Graft Failure

Defined as less than 5% donor chimerism in the cluster of differentiation (CD)3 and CD33 selected cell populations at any time after transplantation. Will be analyzed using KM method. (NCT01707004)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
Decitabine + Bone Marrow Transplant0

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Number of Participants With Complete Remission After Transplantation

(NCT01707004)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Decitabine + Bone Marrow Transplant14

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Cumulative Incidence of Grade III-IV Acute GVHD

Determined by the standard bone marrow transplant (BMT) Clinical Trials Network criteria (BMTCTN). Will be analyzed using KM method, a Graft versus Host Disease (GVHD) grade III-IV will be obtained from the KM estimates along with 95% confidence intervals. (NCT01707004)
Timeframe: Day 100

Interventionpercentage of participants (Number)
Decitabine + Bone Marrow Transplant27.8

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Cumulative Incidence of Chronic GVHD According to BMTCTN

Will be summarized with a proportion and a 95% confidence interval. (NCT01707004)
Timeframe: Up to 1 year

Interventionpercentage (Number)
Decitabine + Bone Marrow Transplant40.7

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Time to Neutrophil Recovery

Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/ul for three consecutive measurements on different days. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05. (NCT01707004)
Timeframe: Up to 1 year

Interventiondays (Mean)
Decitabine + Bone Marrow Transplant16

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Progression Free Survival

(NCT01707004)
Timeframe: Up to 1 year

Interventiondays (Median)
Decitabine + Bone Marrow Transplant141

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Percentage of Participants With Platelet Recovery by Day 30

Platelet recovery is defined as the first day of a platelet count greater than 20,000/mm^3 with no platelet transfusions. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05. (NCT01707004)
Timeframe: Up to day 30

Interventionpercentage with plt engraftment, day 30 (Number)
Decitabine + Bone Marrow Transplant58

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Count of Participants Who Experienced Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

(NCT01807182)
Timeframe: Adverse events will be collected through 4 weeks after T cell infusion. Beginning 4 weeks after the T cell infusion, only study-related toxicities will be collected for up to 1 year following T cell infusion.

InterventionParticipants (Count of Participants)
Treatment (TIL, Combination Chemotherapy, Aldesleukin)10

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A Count of Participants With Biomarker Expression Above Threshold

Several biomarkers, CXCL13+ CD4 cells, CXCL13+ CD8+ cells, and regulatory cells were evaluated to assess correlation with clinical responses to TIL therapy. (NCT01807182)
Timeframe: Up to 24 weeks

InterventionParticipants (Count of Participants)
CXCL13+ as % of CD4 T Cell (40% Threshold)Treg as % of CD4 T Cell (40% Threshold)CXCL13+ as % of CD8 T Cell (40% Threshold)
Treatment (TIL, Combination Chemotherapy, Aldesleukin)236

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Number of Participants Who Experienced in Vivo Persistence of Adoptively Transferred T Cells Following TIL Infusion

Whole exome and RNA sequencing of tumor cells and normal tissue was performed to identify non synonymous missense mutations, which was then used to generate peptide pools to identify neoantigen-reactive T cells. T-Cell Receptor (TCR) sequencing of T cell clonotypes in blood at time of treatment, 10 months and 24 months was performed and used to assess the persistence of a tumor antigen specific clonotype infused in the TIL product. (NCT01807182)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
At time of treatment10 months post infusion24 months post infusion
Treatment (TIL, Combination Chemotherapy, Aldesleukin)111

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Number of Participants Who Experienced Dose-limiting Toxicities (DLT)

Participants that experienced DLT related to the NK Cells post transplant at different dose levels. (NCT01823198)
Timeframe: Up to 42 days

,,,,,
InterventionParticipants (Count of Participants)
Group A: NK cells from KIR mismatched haplo donorsGroup B: NK cells from KIR mismatched cord blood donorsGroup C: NK cells from matched related donors
Phase I: NK Cell Dose Level 1_10^6222
Phase I: NK Cell Dose Level 2_10^7123
Phase I: NK Cell Dose Level 3_ 3x10^7022
Phase I: NK Cell Dose Level 4_ 10^8022
Phase II: NK Cell Dose Level 3_3x10^7010
Phase II: NK Cell Dose Level 4_ 10^80129

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Overall Survival

Participants that survived between day of transplant and day of death on different dose levels. (NCT01823198)
Timeframe: Up to 2 years

,,,,,
InterventionParticipants (Count of Participants)
Group A: NK cells from KIR mismatched haplo donorsGroup B: NK cells from KIR mismatched cord blood donorsGroup C: NK cells from matched related donors
Phase I: NK Cell Dose Level 1_10^6212
Phase I: NK Cell Dose Level 2_10^7010
Phase I: NK Cell Dose Level 3_ 3x10^7003
Phase I: NK Cell Dose Level 4_ 10^8012
Phase II: NK Cell Dose Level 3_3x10^7010
Phase II: NK Cell Dose Level 4_ 10^8072

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Number of Participants With Grade 3 Toxicities

Number of participants that had grade 3 toxicities up to day 42. (NCT01823198)
Timeframe: Up to day 42

,,,,,
InterventionParticipants (Count of Participants)
Group A: NK cells from KIR mismatched haplo donorsGroup B: NK cells from KIR mismatched cord blood donorsGroup C: NK cells from matched related donors
Phase I: NK Cell Dose Level 1_10^6212
Phase I: NK Cell Dose Level 2_10^7122
Phase I: NK Cell Dose Level 3_ 3x10^7012
Phase I: NK Cell Dose Level 4_ 10^8012
Phase II: NK Cell Dose Level 3_3x10^7010
Phase II: NK Cell Dose Level 4_ 10^80116

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Percent Probability of Event-free Survival (EFS)

Probability of Event-free Survival (EFS) for Patients after 18 months. An event is either treatment related mortality (TRM), primary or secondary graft failure, or relapse/non-response (as defined in protocol section 10). Time to event is time from transplant with patients who die between the start of the conditioning regimen and transplant given a time to event of zero. (NCT01824693)
Timeframe: From transplant up to 18 months

Interventionpercent probability (Number)
Arm I (Busulfan, Cyclophosphamide, Melphalan)83
Arm II (Busulfan, Fludarabine Phosphate)22

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Percent Probability of 18 Months-relapse Event Between Arms

Probability of patients relapsing at 18 months. A relapse event is defined in protocol section 10.2.3. Time to relapse/non-response is defined as time from transplant to when all criteria of section 10.2.3 are met. (NCT01824693)
Timeframe: From transplant up to 18 months

Interventionpercent probability (Number)
Arm I (Busulfan, Cyclophosphamide, Melphalan)17
Arm II (Busulfan, Fludarabine Phosphate)55

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Percentage of Participants Who Experience Primary Graft Failure Event Between Arms

Primary Graft failure is defined as the failure to achieve an ANC >= 500/uL after 42 days, determined by 3 consecutive measurements on different days; OR < 5% donor cells in blood or bone marrow by day +42 (as demonstrated by a chimerism assay), without evidence of Juvenile Myelomonocytic Leukemia (JMML). (NCT01824693)
Timeframe: Day 0 - day 540 (18 months) following completion of stem cell transplant

Interventionpercentage of patients (Number)
Arm I (Busulfan, Cyclophosphamide, Melphalan)0
Arm II (Busulfan, Fludarabine Phosphate)0

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Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

To evaluate the side effects of giving Azacytidine before and during chemotherapy using the standard drugs Fludarabine, Cytarabine, IT Cytarabine (AML patients) and IT methotrexate (ALL patients) (NCT01861002)
Timeframe: From Day 1 to Day 42 (Cycle 1)

,
InterventionParticipants (Count of Participants)
# of patients with DLT# of patients without DLT# of patients not evaluable
Dose 75 mg/m2/Day Azacytidine Diagnosed With ALL020
Dose 75 mg/m2/Day Azacytidine Diagnosed With AML0121

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To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD

To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI. (NCT01875237)
Timeframe: Day 28, 56, and 180 post DLI.

,
InterventionParticipants (Count of Participants)
Day 28Day 56Day 180
Transplant Only000
Transplat Plus DLI110

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To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.

To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI. (NCT01875237)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism

To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI) (NCT01875237)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Proportions of GvHD Response Post-administration of AP1903.

To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903

InterventionParticipants (Count of Participants)
Day 3 post-administration of AP190371985950Day 3 post-administration of AP190371985951Day 7 post-administration of AP190371985951Day 7 post-administration of AP190371985950Day 14 post-administration of AP190371985951Day 14 post-administration of AP190371985950Day 28 post-administration of AP190371985951Day 28 post-administration of AP190371985950Day 56 post-administration of AP190371985951Day 56 post-administration of AP190371985950
no responsecomplete responseprogressionpartial response
Transplat Plus DLI1
Transplat Plus DLI0
Transplant Only0

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Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.

Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD (NCT01875237)
Timeframe: 6 months

,
InterventionParticipants (Count of Participants)
disease-free survivaIchimerism post DLIGVHD post DLInon-relapse mortality
Transplant Only0000
Transplat Plus DLI1110

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To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.

"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903." (NCT01875237)
Timeframe: before Day 56 post AP1903

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.

To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events. (NCT01875237)
Timeframe: up to 3.5 years

InterventionParticipants (Count of Participants)
Transplant Only0
Transplat Plus DLI1

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To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903. (NCT01875237)
Timeframe: Day 3, 7, 14, 28, and 56 post-administration of AP1903.

,
InterventionParticipants (Count of Participants)
Day 3 post-administration of AP1903.Day 7 post-administration of AP1903.Day 14 post-administration of AP1903.Day 28 post-administration of AP1903.Day 56 post-administration of AP1903.
Transplant Only00000
Transplat Plus DLI11111

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Number of Participants With Graft Failure

"Primary endpoint:~In each group, the Number of participants with Graft Failure at the 2 years endpoint will be estimated using the Kaplan Meier product limit estimator." (NCT01877837)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Patients With Sickle Cell Anemia3

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Overall Survival

"Secondary endpoints:~Overall survival: The distribution of time to death from any cause will be estimated by Kaplan- Meier product limit function and plotted. The overall survival will be measured from the time of transplant to any death and patients will be followed for 2 years." (NCT01877837)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
Patients With Sickle Cell Anemia23

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Number of Participants That Did Not Progress Within 6 Months

Progression is defined as relapse (NCT01894477)
Timeframe: At 6 months post-transplant

InterventionParticipants (Count of Participants)
Arm A (Treosulfan, Fludarabine Phosphate)20
Arm B (Treosulfan, Fludarabine Phosphate, TBI)48

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Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

(NCT01894477)
Timeframe: Up to 84 days

InterventionParticipants (Count of Participants)
Arm A (Treosulfan, Fludarabine Phosphate)29
Arm B (Treosulfan, Fludarabine Phosphate, TBI)50

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Complete Remission Rate (CR/CRi) in Participants With Relapsed or Refractory AML Following CIML NK Therapy (Phase II)

"Complete remission rate (CR): Morphologically leukemia free state (i.e. bone marrow with <5% blasts by morphologic criteria and no blasts with Auer rods, no evidence of extramedullary leukemia) and absolute neutrophil count ≥1000 /μL and platelets ≥100,000 /μL. Patient must be independent of transfusions~Complete Remission with Incomplete Blood Count Recovery (CRi): All of the above criteria for CR must be met, except that absolute neutrophils <1000 /μL or platelets <100,000 /μL in the blood." (NCT01898793)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells3
Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells0

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Duration of Remission (DOR) (Phase I, Phase II, and Pediatric)

DOR is defined only for patients who achieve a complete remission (CR), complete remission with incomplete blood count recovery (CRi), marrow complete response (mCR), or partial remission (PR), and is measured from the first date of attaining CR or PR until the date of disease progression or death. (NCT01898793)
Timeframe: Up to 3 years

Interventiondays (Median)
Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells126.0
Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells22.0
Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells76.5
Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells30.0
Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells80.0

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Disease Free Survival (DFS) (Phase I, Phase II, and Pediatric)

DFS is defined as the time from the day CR, mCR, or CRi is documented until disease progression or death. (NCT01898793)
Timeframe: Up to 3 years

Interventiondays (Median)
Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells126.00
Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells73.00
Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells56.00
Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells30.00
Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells60.00

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Overall Survival (OS) (Phase I, Phase II, and Pediatric)

OS is defined from the date of first dose of fludarabine on this study until death. (NCT01898793)
Timeframe: Up to 3 years

Interventiondays (Median)
Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells39.00
Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells142.50
Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells49.00
Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells38.00
Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells92.00
Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells147.00

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Time to Progression (Phase I, Phase II, and Pediatric)

TTP is defined as the time from date of first dose of fludarabine until evidence of disease progression. (NCT01898793)
Timeframe: Up to 3 years

Interventiondays (Median)
Phase I Dose Level 1: 0.5 x 10^6/kg CIML NK Cells20.0
Phase I Dose Level 2: 1.0 x 10^6/kg CIML NK Cells36.0
Phase I Dose Level 3: 1.0 x 10^7/kg CIML NK Cells46.0
Phase II (IL-2): 1.0 x 10^7/kg CIML NK Cells33.0
Lead-in Cohort & Phase II (ALT-803): 1.0 x 10^7/kg CIML NK Cells34.0
Pediatric Cohort: 1.0 x 10^7/kg CIML NK Cells28.0

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Maximal Tolerated or Tested Dose (MT/TD) of CIML-NK Cells (Phase I)

Defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity (DLT) or the maximum dose if less than or equal to 1 patient suffers a DLT at the maximum dose. (NCT01898793)
Timeframe: 35 days

Interventionx 10^7 cells/kg (Number)
Phase I1.0

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Number of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)

Clinical response to treatment was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST v1.0). Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD. (NCT01993719)
Timeframe: 4 weeks after cell infusion, then every 3 months x 3 and then every 6 months for 5 years, then per Principal Investigator (PI) discretion up to 5 years or disease progression

,,,
InterventionParticipants (Count of Participants)
First Treatment - Complete ResponseFirst Treatment - Partial ResponseFirst Treatment - Progressive DiseaseFirst Treatment - Stable DiseaseSecond Treatment - Complete ResponseSecond Treatment - Partial ResponseSecond Treatment - Progressive DiseaseSecond Treatment - Stable Disease
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin2221NANANANA
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin02830111
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinNANANANA0110
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin0201NANANANA

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Overall Response Rate (ORR)

Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.

,
Interventionpercentage of participants (Number)
Initial Treatment
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin57.10
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin16.70

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Overall Response Rate (ORR)

Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.

Interventionpercentage of participants (Number)
Retreat
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin50

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Overall Response Rate (ORR)

Overall response is the best response recorded from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.0). Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression, up to approximately 67.2 months.

Interventionpercentage of participants (Number)
Initial TreatmentRetreat
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin23.1033.30

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Progression-free Survival (PFS)

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.

,
InterventionMonths (Median)
Initial Treatment
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin7.9
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin2.1

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Progression-free Survival (PFS)

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.

InterventionMonths (Median)
Retreat
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin32.5

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Progression-free Survival (PFS)

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Date of cells until time of disease progression up to approximately 67.2 months.

InterventionMonths (Median)
Initial TreatmentRetreat
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin3.11.6

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Overall Survival

Overall survival is defined as the time from treatment start date until date of death, or date last known alive. (NCT01993719)
Timeframe: Date of cells until time to death, up until 90.1 months.

InterventionMonths (Median)
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin14.3
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg AldesleukinNA
Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin15.1

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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01993719)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 9 days, 92 months and 19 days, 86 months and 9 days, 99 months and 16 days, and 86 months and 26 days for each group respectively.

InterventionParticipants (Count of Participants)
Arm 1N -Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin7
Arm 1P - Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin9
Arm 2/Foll By Arm 1P-Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin3
Arm 2- Low Dose Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin9
Arm 1P/Foll By Arm-1P/R-Standard Chemotherapy Preparative Regimen + TIL + 720,000 IU/kg Aldesleukin2

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Overall Progression Free Survival (PFS)

PFS is defined as the time to disease progression following the start of treatment, and time to death following the start of treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 and is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01993719)
Timeframe: Time to progression and time to death, approximately up to 67.2 months.

InterventionMonths (Median)
All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R3

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Overall Survival

Overall survival is defined as the time from treatment start date until date of death, or date last known alive. (NCT01993719)
Timeframe: An average of 25.6 months.

InterventionMonths (Median)
All Participants in Arms 1N, 1P, Arm 2/Foll By Arm 1P, Arm 2, and Arm 1P/Foll By Arm 1P/R17.5

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Progression-free Survival (PFS) Rate at 3 Years

"PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following:~≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart~≥ 50% increase from nadir since start of tx in the size of liver and/or spleen~≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10^9/L to qualify as disease progression.~Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with > 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count > 5x10^9/L and/or recurrence of palpable lymphadenopathy > 1.5 cm by physical exam." (NCT02048813)
Timeframe: Assessed every 3 months until progression up to 4 years and 8 months

InterventionProportion of participants (Number)
Arm A (Ibrutinib, Rituximab)0.894
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)0.729

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Overall Survival (OS) Rate at 3 Years

Overall survival was defined as time from randomization to death from any cause or date last known alive. Overall survival rate at 3 years was estimated using the method of Kaplan-Meier. (NCT02048813)
Timeframe: Assessed every 3 months until progression; after progression, assessed every 3 months for first 2 years, every 6 months for years 3-5, up to 4 years and 8 months

InterventionProportion of participants (Number)
Arm A (Ibrutinib, Rituximab)0.988
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)0.915

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12 Month Disease Free Survival Probability

The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier. (NCT02248597)
Timeframe: At 12 months

Interventionpercentage of participants (Number)
Treatment (Stem Cell Transplant With GVHD Prophylaxis)51.8

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Overall Survival

The survival function will be estimated and plotted using the method of Kaplan and Meier. (NCT02248597)
Timeframe: At 12 months

Interventionpercentage of participants (Number)
Treatment (Stem Cell Transplant With GVHD Prophylaxis)66.7

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Progression Free Survival

Kaplan-Meier estimation of the percentage of patients who are alive without progressive disease at one year. (NCT02248597)
Timeframe: At 12 months

Interventionpercentage of participants (Number)
Treatment (Stem Cell Transplant With GVHD Prophylaxis)51.8

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Rate of Acute GvHD

Kaplan-Meier estimation of the rate of acute GvHD in the study population at one year with a 95% confidence interval. (NCT02248597)
Timeframe: 12 months

Interventionpercentage of participants (Number)
Treatment (Stem Cell Transplant With GVHD Prophylaxis)51.8

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Relapse-free Mortality

Non-relapse mortality will be defined as time from registration to death due to anything other than relapse of hematological malignancy. Patients who relapse will be treated as a competing risk. (NCT02248597)
Timeframe: At 12 months

Interventiondays (Mean)
Treatment (Stem Cell Transplant With GVHD Prophylaxis)86.8

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Incidence and Severity of Chronic GvHD

"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given." (NCT02259348)
Timeframe: one year post transplantation

Interventionparticipants (Number)
MildModerateSevere
Participants000

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Event-free Survival (EFS)

The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given. (NCT02259348)
Timeframe: one year post transplantation

Interventionparticipants (Number)
Participants2

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Incidence of Malignant Relapse

The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease. (NCT02259348)
Timeframe: one year post transplantation

Interventionparticipants (Number)
Participants2

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Mean of Days to Absolute Neutrophil Count (ANC) Engraftment

ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment. (NCT02259348)
Timeframe: Day 42 post transplantation

Interventiondays (Mean)
Participants10.3

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Median Days to Absolute Neutrophil Count (ANC) Engraftment

ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment. (NCT02259348)
Timeframe: Day 42 post transplantation

Interventiondays (Median)
Participants10

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Overall Survival (OS)

The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given. (NCT02259348)
Timeframe: one year post transplantation

Interventionparticipants (Number)
Participants2

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Percentage of Participants Engrafted by Day 42 Post-transplant

To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment. (NCT02259348)
Timeframe: Day 42 post transplantation

Interventionpercentage of participants (Number)
Participants100

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Incidence and Severity of Acute GvHD

The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe. (NCT02259348)
Timeframe: 100 days post transplantation

Interventionparticipants (Number)
Grade IGrade IIGrade IIIGrade IV
Participants0031

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Clinical Response to Crenolanib With Standard Salvage Chemotherapy

To determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but >5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. (NCT02626338)
Timeframe: 1 year

,,,
InterventionParticipants (Count of Participants)
Composite complete remission (CR+CRh+CRi)MLFSClinical benefit (CRc+PR+MLFS)
All Subjects737
Arm A: HAM Chemotherapy323
Arm B: FLAG-Ida Chemotherapy404
Arm C: MEC Chemotherapy010

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Liposome-encapsulated Cytarabine Clearance

Geometric mean liposome-encapsulated cytarabine clearance following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionMILLILITER / HOUR (Geometric Mean)
Treatment (CPX-351 and FLAG)71.76

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Liposome-encapsulated Cytarabine Time of Maximum Concentration

Median liposome-encapsulated cytarabine time of maximum observed plasma concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionHOUR (Median)
Treatment (CPX-351 and FLAG)5

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Liposome-encapsulated Cytarabine Volume of Distribution

Geometric mean liposome-encapsulated cytarabine volume of distribution following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionMILLILITER (Geometric Mean)
Treatment (CPX-351 and FLAG)4158.0

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Liposome-encapsulated Daunorubicin Area Under the Curve

Geometric mean liposome-encapsulated daunorubicin area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

Intervention(NANOGRAM x HOUR) / MILLILITER (Geometric Mean)
Treatment (CPX-351 and FLAG)1288010.3

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Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy

Response (complete response or complete remission with partial or incomplete platelet recovery) after first cycle of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated by the total of number of patients with complete response or complete remission with partial or incomplete platelet recovery divided by the number of patients evaluable for response after the first cycle. 95% confidence interval is determined using a binomial exact method. (NCT02642965)
Timeframe: Up to 4 weeks

InterventionPercentage of responders (Number)
Treatment (CPX-351 and FLAG)75.68

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Liposome-encapsulated Daunorubicin Clearance

Geometric mean liposome-encapsulated daunorubicin clearance following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionMILLILITER / HOUR (Geometric Mean)
Treatment (CPX-351 and FLAG)94.7

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Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles

Best response (complete response or complete remission with partial platelet recovery) after up to 2 cycles of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated using the methods of Jung and Kim. 90% confidence interval is determined using the methods of Koyama and Chen. (NCT02642965)
Timeframe: Up to 8 weeks

InterventionPercantage of best responders (Number)
Treatment (CPX-351 and FLAG)68.30

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Liposome-encapsulated Daunorubicin Time of Maximum Concentration

Median liposome-encapsulated daunorubicin time of maximum observed plasma concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionHOUR (Median)
Treatment (CPX-351 and FLAG)2

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Liposome-encapsulated Daunorubicin Volume of Distribution

Geometric mean liposome-encapsulated daunorubicin volume of distribution following IV infusion will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

InterventionMILLILITER (Geometric Mean)
Treatment (CPX-351 and FLAG)3827.7

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Number of Participants With a Dose-limiting Toxicity

Number of patients in the dose-finding phase with a dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. (NCT02642965)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Treatment (CPX-351 and FLAG)1

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Liposome-encapsulated Cytarabine Area Under the Curve

Geometric mean liposome-encapsulated cytarabine area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase. (NCT02642965)
Timeframe: Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1

Intervention(NANOGRAM x HOUR) / MILLILITER (Geometric Mean)
Treatment (CPX-351 and FLAG)4418582.5

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Number of Participants With Severe Chronic GVHD

The number of participants with severe chronic GVHD by Day +180 will be reported. (NCT02652468)
Timeframe: Day +180

InterventionParticipants (Count of Participants)
Peripheral Blood Stem Cell Transplant0

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Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma. (NCT02652468)
Timeframe: At day 28 after transplantation

InterventionParticipants (Count of Participants)
Peripheral Blood Stem Cell Transplant11

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Overall Survival (OS)

(NCT02652468)
Timeframe: Median follow up of 1689 days

Interventiondays (Median)
Peripheral Blood Stem Cell Transplant352

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Progression-free Survival

Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow, (NCT02652468)
Timeframe: Median follow up of 1689 days

Interventiondays (Median)
Peripheral Blood Stem Cell Transplant352

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Number of Participants With Graft Failure

Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved. (NCT02652468)
Timeframe: Up to 2 years after graft

InterventionParticipants (Count of Participants)
Peripheral Blood Stem Cell Transplant0

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Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria

The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported. (NCT02652468)
Timeframe: Day +100

InterventionParticipants (Count of Participants)
Peripheral Blood Stem Cell Transplant3

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Acute Graft Versus Host Disease Among Patients Who Received Early Transplant

Acute graft versus host disease (graded II, III, or IV) among patients who received early allogeneic HCT on study. (NCT02756572)
Timeframe: At day 100

InterventionParticipants (Count of Participants)
Received Allogeneic HCT on Study0

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Demonstrate the Feasibility of Collecting Resource Utilization Data for Trial Participants

The amount of days of hospitalization (the major driver of costs within the first year) will be collected for resource utilization. (NCT02756572)
Timeframe: Within the first year of induction chemotherapy on study

Interventiondays (Median)
Treatment (Chemotherapy, HCT)49

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Event-free Survival (EFS) Among Patients Who Received Early Transplant

Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. (NCT02756572)
Timeframe: Up to 100 days post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study91

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Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84

"Complete Remission (CR), defined as <5% blasts in bone marrow with hematologic recovery (ANC>1000/ul and platelets >100,000/ml).~CRi, defined as complete remission with insufficient hematologic recovery (ANC<1000/ul or platelets<100,000/ul).~CRp, defined as complete remission but platelets <100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria.~Morphologic leukemia-free state (MLFS), defined as <5% blasts in bone marrow with no hematologic recovery.~Relapse, defined as >5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease." (NCT02756572)
Timeframe: Approximately 84 days after early allogeneic HCT

InterventionParticipants (Count of Participants)
CR with MRDCR without MRDCRi with MRDCRi without MRDMLFS with MRDMLFS without MRDRelapse
Received Allogeneic HCT on Study0402002

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Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28

"Complete Remission (CR), defined as <5% blasts in bone marrow with hematologic recovery (ANC>1000/ul and platelets >100,000/ml).~CRi, defined as complete remission with insufficient hematologic recovery (ANC<1000/ul or platelets<100,000/ul).~CRp, defined as complete remission but platelets <100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria.~Morphologic leukemia-free state (MLFS), defined as <5% blasts in bone marrow with no hematologic recovery.~Relapse, defined as >5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease." (NCT02756572)
Timeframe: Approximately 28 days after early allogeneic HCT

InterventionParticipants (Count of Participants)
CR with MRDCR without MRDCRi with MRDCRi without MRDMLFS with MRDMLFS without MRDRelapse
Received Allogeneic HCT on Study0701000

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Event-free Survival (EFS) Among Patients Who Received Early Transplant

Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. (NCT02756572)
Timeframe: Up to 6 months post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study82

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Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE

Patients who receive early transplant will be compared to those that don't using the Wilcoxon rank sum test for the quantitative variable of age. (NCT02756572)
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)

Interventionyears (Median)
Received Allogeneic HCT on Study55
Did Not Receive Allogeneic HCT on Study57

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Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant

Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days after induction day 1

InterventionPercentage of participants (Number)
Did Not Receive Allogeneic HCT on Study75

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Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant

Success will be defined as observing a 40% of higher 6-month relapse-free survival among patients who received early transplant on study. (NCT02756572)
Timeframe: 6 months after early allogeneic HCT on study

InterventionParticipants (Count of Participants)
No relapse within 6 months post-HCT (feasibility success)Relapse within 6 months post-HCT (feasibility failure)
Received Early Allogeneic HCT on Study62

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Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant

Success will be defined as enrollment of at least 30 patients with transplants occurring in 15 of these 30 (50%) within 60 days of enrollment or start of induction chemotherapy with G-CLAM, whichever is earlier. (NCT02756572)
Timeframe: Up to 60 days after start of chemotherapy

InterventionParticipants (Count of Participants)
Received allogeneic HCT on study within 60 days (feasibility success)Did not receive allogeneic HCT on study within 60 days (feasibility failure)
Treatment (Chemotherapy, HCT)921

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Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - GENDER

Patients who receive early transplant will be compared to those that don't using the Fisher's exact test for the categorical variables of gender. (NCT02756572)
Timeframe: From time of subject's study enrollment to time of subject's feasibility success assessment (i.e. when subject received transplant within 60 days or when it was determined subject would not proceed with transplant on study)

,
InterventionParticipants (Count of Participants)
FemaleMale
Did Not Receive Allogeneic HCT on Study1011
Received Allogeneic HCT on Study81

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Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants

The amount of returned patient-reported outcome questionnaires will be summarized for each collection timepoint using percent collection from surviving patients for PRO timepoints. (NCT02756572)
Timeframe: Up to 12 months post-HCT

InterventionParticipants (Count of Participants)
Enrollment PROs returnedPost G-CLAM PROs returnedPre-HCT PROs returned6 months post-HCT PROs returned12 months post-HCT PROs returned
Treatment (Chemotherapy, HCT)2723843

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Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant

Overall survival among patients who did not receive early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months after induction day 1

InterventionPercentage of participants (Number)
Did Not Receive Allogeneic HCT on Study62

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Overall Survival (OS) Among Patients Who Received Early Transplant.

Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study82

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Overall Survival (OS) Among Patients Who Received Early Transplant.

Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study91

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Relapse-free Survival (RFS) Among Patients Who Received Early Transplant

Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 6 months post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study82

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Relapse-free Survival (RFS) Among Patients Who Received Early Transplant

Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. (NCT02756572)
Timeframe: Up to 100 days post-transplant

InterventionPercentage of participants (Number)
Received Allogeneic HCT on Study91

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Event-free Survival (EFS) Rate

Event-free Survival (EFS) is defined as the survival with stable donor erythropoiesis with no new clinical evidence of sickle cell disease (SCD). Primary or late graft rejection with disease recurrence or death will count as events for this endpoint. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient5

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Infection Rate

Significant infections will be recorded including but not limited to bacterial or fungal sepsis, CMV reactivation with/without clinical disease, adenovirus infection, EBV PTLD, other significant viral reactivations or community-acquired viral infections and invasive mold infections. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient5

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Frequency of Stroke

An overt stroke is defined as a focal neurologic event and neurologic deficit lasting > 24 hours with neuroimaging changes. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient0

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Frequency of Idiopathic Pneumonia Syndrome (IPS)

"IPS is diagnosed by evidence of widespread alveolar injury:~Radiographic evidence of bilateral, multi-lobar infiltrates (by chest x-ray or CT scan); AND~Evidence of abnormal respiratory physiology based upon oxygen saturation (SpO2) < 93% on room air or the need for supplemental oxygen to maintain oxygen saturation ≥ 93%; AND~Absence of active lower respiratory tract infection" (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient0

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Late Graft Rejection Rate

The absence of donor hematopoietic cells in peripheral blood beyond day 42 up to 1 year in a patient who had initial evidence of hematopoietic recovery with > 20% donor cells will be considered a late graft rejection. (NCT02757885)
Timeframe: Day 42 Post transplant up to 1 year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient0

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Chimerism Rate Following Hematopoietic Cell Transplantation for Sickle Cell Disease

Genomic DNA extracted from peripheral blood will be analyzed for variable number of tandem repeats (VNTR) to detect donor engraftment in myeloid and lymphoid fractions. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient5

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Veno-occlusive Disease (VOD) Rate

"VOD is diagnosed by the presence of ≥ 2 of the following with no other identifiable cause for liver disease:~Jaundice (direct bilirubin ≥ 2 mg/dL or > 34 μmol/L)~Hepatomegaly with right upper quadrant pain~Ascites and/or weight gain (> 5% over baseline)" (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient0

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Rate of Disease Recurrence

Disease recurrence is defined as the return of sickle erythropoiesis (HbS level > 70%) and the absence of donor cell representation. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient1

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Rate of Central Nervous System (CNS) Toxicity

CNS toxicity will be defined as seizures, CNS hemorrhage, or PRES. PRES is defined as an increased diffusion coefficient in areas of T2 hyperintensity on diffusion-weighted imaging in the context of clinical symptoms or physical findings including headache, seizures, visual disturbances, and altered level of consciousness. (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient2

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Primary Graft Rejection Rate

Primary graft rejection is defined as the absence of donor cells assessed by peripheral blood chimerism assays on day 42. Primary graft rejection can be accompanied by pancytopenia and marrow aplasia or by autologous hematopoietic reconstitution without aplasia. (NCT02757885)
Timeframe: Day 42

InterventionParticipants (Count of Participants)
Bone Marrow Recipient1

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Overall Survival Rate

Overall survival is defined as survival with or without sickle cell disease (SCD) after hematopoietic cell transplantation (HCT). (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient6

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Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment.

"Cumulative incidence of Neutrophil Engraftment and Platelet Engraftment. Neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of ≥ 500/µL after conditioning.~Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL and did not receive a platelet transfusion in the previous 7 days." (NCT02757885)
Timeframe: Up to One Year

InterventionParticipants (Count of Participants)
Bone Marrow Recipient5

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Number of Participants With Toxicity Graded According to NCI-CTCAE Version 4.0

Toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. (NCT02774291)
Timeframe: Up to 15 years

InterventionParticipants (Count of Participants)
Treatment (mTCR, Aldesleukin)2

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Complete Response

Complete response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Interventionpercentage of participants (Number)
Interventions: Selinexor, Fludarabine, and Cytarabine46.4

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Complete Response or Complete Response With Incomplete Count Recovery

Complete response or complete response with incomplete count recovery, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Interventionpercentage of participants (Number)
Interventions: Selinexor, Fludarabine, and Cytarabine50.0

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The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)

Complete response or complete response with incomplete count recovery or partial response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study (NCT03071276)
Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Interventionpercentage of participants (Number)
Interventions: Selinexor, Fludarabine, and Cytarabine53.6

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Acute Graft Versus Host Disease (aGVHD) of Grades 2-4 According to the Consensus Grading

Acute graft versus host disease is graded according to the 1994 Keystone Consensus Grading. aGVHD grade was evaluated from day 0 through 100 days post-transplant. The first day of acute GVHD onset at grades 2-4 was used to calculate the cumulative incidence. Relapse/death prior to onset was considered competing events. (NCT03128359)
Timeframe: Up to 100 days post-stem cell infusion

Interventionpercentage of probability (Number)
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)47
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)53

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Graft-Versus-Host Disease-Free, Relapse-Free Survival (GRFS) at 1 Year

Estimates will be calculated using the Kaplan-Meier method, Greenwood formula will be used to calculate standard error (SE), and log-log transformation method will be used to construct 95% confidence intervals. Graft versus host disease (GVHD, acute and chronic), disease status and vital status will be monitored per clinical standard operating procedure. For this endpoint failure is defined as the first occurrence of grade 3 or 4 acute GVHD, or moderate/severe chronic GVHD, or disease relapse (for patients in complete remission at the start of conditioning) or disease progression (for patients with active disease at the start of conditioning) or death (from any cause). Patients not experiencing any of these will be censored at his/her date of last contact. (NCT03128359)
Timeframe: From stem cell infusion to grade 3-4 acute graft versus host disease (GVHD), moderate-severe chronic GVHD, relapse, progression or death (from any cause), whichever occurs first, assessed for up to 1 year.

Interventionpercentage of survival probability (Number)
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)53
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)84

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Overall Survival (OS) at 1 Year

Estimates was calculated using the Kaplan-Meier method, Greenwood formula was used to calculate SE, and log-log transformation method was used to construct 95% confidence intervals. Each patient's vital status was monitored per clinical standard operating procedure. For this endpoint failure is defined as death (from any cause). Patients not experiencing a death event was censored at his/her date of last contact. (NCT03128359)
Timeframe: From start of transplant to death, or last follow up, whichever occurs first, assessed for up to 1 year.

Interventionpercentage of probability (Number)
Regimen A (Fludarabine, Melphalan, PBSC HCT, GVHD Prophylaxis)68
Regimen C (Fludarabine, TBI, PBSC HCT, GVHD Prophylaxis)100

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Overall Survival

Overall Survival (OS), defined as time from TIL infusion to death (NCT03287674)
Timeframe: Up to 3 years after TIL infusion

InterventionDays (Median)
TIL Treated Patients247

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Progression Free Survival

Progression free survival (PFS): Time from TIL infusion to disease progression, relapse or death due to any cause, which ever comes first, will be used as an event. (NCT03287674)
Timeframe: Up to 12 months after TIL infusion

InterventionDays (Median)
TIL Treated Patients93

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Number of Participants With Reported Adverse Events by Type

Determine the safety of TIL therapy in combination with checkpoint inhibitors for patients with ovarian-, fallopian tube or primary peritoneal cancer by reporting adverse events according to CTCAE v. 4.0. (NCT03287674)
Timeframe: Up to 12 months

InterventionParticipants (Count of Participants)
Performance status dropFatigueNauseaVomitingDiarrheaHyponatremiaInfectionNeutropeniaTrombocytopeniaAnemiaAgammaglobulinemiaDyspneaFeverColitisDry skin
TIL Treated Patients331113266611311

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Number of Participants With Adverse Events Attributable to MLN4924 (Pevonedistat)

Frequency of patients with at least one grade 3 adverse event at least possibly attributable to MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level. (NCT03813147)
Timeframe: Up to 70 days

InterventionParticipants (Count of Participants)
Stratum 1 With 20 mg/m^26
PK With 20 mg/m^26

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Number of Participants With Antitumor Activity of MLN4924 (Pevonedistat)

Frequency of participants with best overall response by dose level of PR or CR for MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction Per Response Evaluation Criteria for CR (M1 bone marrow (< 5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral blood counts (ANC > 1000/uL and platelet count > 100,000/uL), CRp (M1 bone marrow (< 5% blasts) and no evidence of circulating blasts or extramedullary disease and with recovery of ANC > 1000/uL and platelet transfusion independence), CRi (M1 bone marrow (<5% blasts) and no evidence of circulating blasts or extramedullary disease and with ANC < 1000/uL or platelet count < 100,000/uL without platelet transfusion independence), or PR (M2 marrow status (> 5% or < 25% blasts cells) and at least 50% decrease in bone marrow blast percent from baseline. (NCT03813147)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
Stratum 1 With 20 mg/m^21
PK With 20 mg/m^22

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Number of Participants With Dose Limiting Toxicities of MLN4924 (Pevonedistat)

Frequency of patients with dose limiting toxicity in the first cycle of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level among patients in the dose escalation cohort. (NCT03813147)
Timeframe: Up to 35 days

InterventionParticipants (Count of Participants)
Stratum 1 With 20 mg/m^21
PK With 20 mg/m^22

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Total Plasma Clearance of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS

Median (Range) of the total plasma clearance of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days

InterventionL/h/m^2 (Median)
Stratum 1 With 20 mg/m^220.1
PK With 20 mg/m^219.2

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Maximum Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS

Median (Range) of the maximum concentration of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days

Interventionng/mL (Median)
Stratum 1 With 20 mg/m^2248.5
PK With 20 mg/m^2213

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Elimination Half-life of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS

Median (Range) of the elimination half-life of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days

InterventionHour (Median)
Stratum 1 With 20 mg/m^24.7
PK With 20 mg/m^25.5

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Area Under the Plasma Concentration Versus Time Curve of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS

Median (Range) of the area under the plasma concentration versus time curve of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days

Interventionhr*ng/mL (Median)
Stratum 1 With 20 mg/m^21004.9
PK With 20 mg/m^21047.4

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Maximum Time to Concentration of MLN4924 (Pevonedistat) Added to the 3-drug Backbone of Azacitidine (Aza), Fludarabine, and Cytarabine Re-induction for Pediatric Patients With Recurrent/Refractory AML and MDS

Median (Range) of the maximum time to concentration of MLN4924 (pevonedistat) added to the 3-drug backbone of azacitidine (aza), fludarabine, and cytarabine re-induction for pediatric patients with recurrent/refractory AML and MDS by dose level measured pre-dose, end of infusion, 4-6 hours, and 24 hours post-dose infusion on Days 1 and 5. (NCT03813147)
Timeframe: Up to 5 days

InterventionHour (Median)
Stratum 1 With 20 mg/m^21.2
PK With 20 mg/m^21.1

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Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

Defined by any grade 3 or NCI CTCAE toxicities and modified CRS grading as applicable. (NCT03873805)
Timeframe: Up to 28 days post treatment

InterventionParticipants (Count of Participants)
Dose Level 10
Dose Level 22
Dose Level 30

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Grade 3 Toxicity Profile

Grade 3 toxicity profile as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 and modified Cytokine Release Syndrome (CRS) grading as applicable post chimeric antigen receptor (CAR) T cell infusion. (NCT03873805)
Timeframe: Up to 32 months

,,
InterventionParticipants (Count of Participants)
Anemia : YesAnemia : NoLymphocyte count decreased : YesLymphocyte count decreased : NoFatigue : YesFatigue : NoPain : YesPain : NoCystitis noninfective : YesCystitis noninfective : NoHematuria : YesHematuria : NoRash maculo-papular : YesRash maculo-papular : No
Dose Level 121120303030303
Dose Level 224062415241515
Dose Level 305140505050505

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