Page last updated: 2024-11-04

mechlorethamine

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Description

nitrogen mustard : Compounds having two beta-haloalkyl groups bound to a nitrogen atom, as in (X-CH2-CH2)2NR. [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 CID4033
CHEMBL ID427
CHEBI ID28925
SCHEMBL ID3861
MeSH IDM0013168

Synonyms (159)

Synonym
nsc-128663
bis(2-chloroethyl)methylamine
KBIO1_000759
DIVK1C_000759
NCI60_041682
n-methyl-2,2'-dichlorodiethylamine
hsdb 5083
dichlor amine
antimit
t 1024
n-methyl-lost [german]
ethanamine, 2-chloro-n-(2-chloroethyl)-n-methyl-
hn-2
tl 146
n,n-bis(2-chloroethyl)methylamine
ccris 447
methyldi(2-chloroethyl)amine
cloramin
n-methyl lost
stickstofflost (ebewe)
2,2'-dichlorodiethyl-methylamine
chlormethinum [inn-latin]
mustine note
mecloretamina [italian]
clormetina [inn-spanish]
chloramine (the nitrogen mustard)
n-methyl-bis-chloraethylamin [german]
diethylamine, 2,2'-dichloro-n-methyl-
einecs 200-120-5
ent-25294
di(2-chloroethyl)methylamine
mechloroethamine
brn 0605323
chlormethine [inn:ban]
n,n-di(chloroethyl)methylamine
t-1024
n-methyl-bis(beta-chloroethyl)amine
methylbis(beta-chloroethyl)amine
beta,beta'-dichlorodiethyl-n-methylamine
methylbis(2-chloroethyl)amine
n-methyl-bis(2-chloroethyl)amine
CHEBI:28925 ,
bis(beta-chloroethyl)methylamine
SPECTRUM_000889
BSPBIO_001947
D07671
chlormethine (inn)
chlorethazine
stickstofflost (*hydrochloride*)
2-chloro-n-(2-chloroethyl)-n-methylethanamine
nitrogranulogen
n,n-bis(2-chloroethyl)-n-methylamine
n-lost
2-chloro-n-(2-chloroethyl)-n-methyl-ethanamine
2,2'-dichloro-n-methyldiethylamine
nitol (*hydrochloride*)
carolysine
mebichloramine
caryolysine
mustargen
HN2 ,
mitoxine (*hydrochloride*)
embichin
embechine
mustine
.beta.,.beta.'-dichlorodiethyl-n-methylamine
1, 5-dichloro-3-methyl-3-azapentane hydrochloride
IDI1_000759
SPECTRUM5_001702
nsc 762
chlormethine
mechlorethamine ,
51-75-2
C07115
nitrogen mustard
DB00888
NCGC00091835-04
NCGC00091835-02
NCGC00091835-03
KBIO3_001447
KBIOGR_001448
KBIO2_003937
KBIO2_006505
KBIOSS_001369
KBIO2_001369
SPECTRUM4_000924
NINDS_000759
SPBIO_000496
SPECTRUM2_000448
SPECTRUM3_000484
SPECTRUM1500375
NCGC00091835-05
HMS2091B04
nsc-757087
nitrogen mustard (hn 2)
CHEMBL427
HMS502F21
HMS1920J15
A8064
NCGC00091835-06
NCGC00091835-07
NCGC00091835-08
valchlor
clormetina
n-methyl-bis-chloraethylamin
n-methyl-lost
mecloretamina
50d9xsg0vr ,
nitrogen mustard (hn-2)
unii-50d9xsg0vr
chlormethinehydrochloride
AKOS006229862
pharmakon1600-01500375
nsc757087
CCG-39885
NCGC00091835-09
mechlorethamine [hsdb]
mechlorethamine [vandf]
nitrogen mustard [iarc]
methyl-.beta.,.beta.-dichlorodiethylamine
chlormethine [inn]
mechlorethamine [mi]
chlormethine [who-dd]
EPITOPE ID:116224
ledaga
gtpl7218
bis(2-chloroethyl)(methyl)amine
STL484282
bis(chloroethyl)methylamine
n-methyldi-(2-chloroethyl)amine
bis(2-chloro-ethyl)-methyl-amine
n-methylbis(2-chloroethyl)amine
bis-(2-chloro-ethyl)-methyl-amine
bis-(2-chloro-ethyl)-methylamine
SCHEMBL3861
AB00052033-04
methyl-bis(2-chloroethyl)amine
n-methyl-bis(.beta.-chloroethyl)amine
dichloren (salt/mix)
embichin (salt/mix)
nitol (salt/mix)
methylbis(.beta.-chloroethyl)amine
bis(.beta.-chloroethyl)methylamine
caryolysin (salt/mix)
bis(b-chloroethyl)methylamine
hn2 (amine)
caryolysine (salt/mix)
eraso (salt/mix)
n,n-bis(2-chloroethyl)-n-methylamine #
n-methyl-di(2-chloro)-ethylamine
DTXSID2020975
sr-05000001664
SR-05000001664-1
bdbm200297
ab00052033_05 ,
cid_4033
SBI-0051432.P003
Q418011
BRD-K12829205-001-03-0

Research Excerpts

Overview

Mechlorethamine (HN2) is a derivative of the chemical warfare agent sulfur mustard (SM) and cutaneous exposure to HN2 is associated with dermal-epidermal junction (DEJ) disruption (vesication)

ExcerptReferenceRelevance
"Mechlorethamine (HN2) is a derivative of the chemical warfare agent sulfur mustard (SM) and cutaneous exposure to HN2 is associated with dermal-epidermal junction (DEJ) disruption (vesication). "( Dysregulation of the mTOR pathway by mechlorethamine.
Billack, B; Cuffari, BJ; Mao, G; Rao, TJR, 2023
)
2.63
"Mechlorethamine (HN2) is an alkylating agent usually used in cancer chemotherapy. "( Toxic effects of mechlorethamine on mammalian respiratory mucociliary epithelium in primary culture.
Boivieux-Ulrich, E; Giuliani, I; Guennou, C; Houcine, O; Marano, F, 1994
)
2.07
"Mechlorethamine therapy is a cost-effective and easily administered treatment for cutaneous T-cell lymphomas. "( A prospective study of cutaneous intolerance to topical mechlorethamine therapy in patients with cutaneous T-cell lymphomas. French Study Group of Cutaneous Lymphomas.
Avril, MF; Bagot, M; Beylot-Barry, M; Delaunay, M; Estève, E; Grange, F; Joly, P; Laroche, L; Souteyrand, P; Thomine, E; Vaillant, L; Wechsler, J, 1999
)
1.99
"Mechlorethamine, is an immunomodulator widely used in therapy although its effect on plasma membrane - bound enzymes is unclear. "( The influence of mechlorethamine on the activity of ecto-ATPase of rat lymphocytes.
Calkosinski, I; Purzyc, L, 2001
)
2.09

Effects

ExcerptReferenceRelevance
"Mechlorethamine has been assessed in 28 patients with idiopathic nephrotic syndrome previously treated with prednisone only. "( [Effect of mechlorethamine in idiopathic nephrotic syndrome in childhood].
Canals, MJ; Cervera, A; Gómez Campderá, FJ; Gómez Campderá, J; López Gómez, JM; Luque, A; Morales, JL, 1984
)
2.1

Treatment

ExcerptReferenceRelevance
"Mechlorethamine treatment significantly decreased in vitro amplification of PrP(Sc) in the highly efficient protein misfolding cyclic amplification system."( Alkylating antitumor drug mechlorethamine conceals a structured PrP domain and inhibits in vitro prion amplification.
Bi, H; Shimoji, M; Wang, GX; Wang, Y; Wong, J; Xiao, X; Yuan, J; Zhou, X; Zou, WQ, 2011
)
1.39

Toxicity

ExcerptReferenceRelevance
" This side effect could be explained by a cycling of the hematopoietic stem-cells and call to some caution when androgens are used during cancer chemotherapy."( [Increased hematological toxicity of antineoplastic drugs with simultaneous androgenotherapy (author's transl)].
Barthélémy, M; Bilski-Pasquier, G; Blanc, CM; Bouchard, M; Bousser, J; Zittoun, R, 1977
)
0.26
" HN2 was much less toxic to hepatocytes under nitrogen and caused much less lipid peroxidation than under aerobic conditions."( Hepatocyte toxicity of mechlorethamine and other alkylating anticancer drugs. Role of lipid peroxidation.
Khan, S; O'Brien, PJ; Ramwani, JJ, 1992
)
0.59
"3 microM, ethacrynic acid was toxic to 8 of 24 (33%) tumor specimens studied."( Enhancement of anthracycline and alkylator cytotoxicity by ethacrynic acid in primary cultures of human tissues.
Kern, DH; Messenger, JC; Nagourney, RA; Weisenthal, LM, 1990
)
0.28
"Pulmonary toxicity is a well recognised side effect of anticancer agents particularly bleomycin, cyclophosphamide, methotrexate, and busulphan."( Pulmonary toxicity following MOPP chemotherapy.
Byrne, MJ; Cohney, SJ; Millward, MJ; Ryan, GF, 1990
)
0.28
" There were three fatal toxic events, two due to viral infection and one to a second malignant tumor (NHL)."( Hodgkin's disease in children: treatment with MOPP and low-dose, extended field irradiation without laparotomy. Late results and toxicity.
Berry, M; Blanchette, V; Chan, H; Doherty, M; Doyle, J; Freedman, M; Greenberg, M; Jenkin, D; Panzarella, T; Saunders, F, 1990
)
0.28
" In comparison with control cells that were transfected with the parent vector, the ATase-expressing clones were considerably more resistant to the toxic effects of the methylating agents N-methyl-N-nitrosourea and methylmethanesulphonate or the chloroethylating agents Mz or taurine chloroethylnitrosourea, but unchanged in their susceptibility to the bis-chloroethylating agent nitrogen mustard."( Transfection of murine multi-potent haemopoietic stem cells with an E. coli DNA alkyltransferase gene confers resistance to the toxic effects of alkylating agents.
Dexter, TM; Jelinek, J; Kleibl, K; Margison, GP, 1988
)
0.27
" Nitrogen mustard [(HN2) NCS-762] and x-rays were selectively toxic to P388/R cells."( Flow cytometric screening for selective toxicity to multidrug-resistant cells.
Frankfurt, OS, 1987
)
0.27
" On the other hand, acrolein was most toxic to cell proliferation and most active in inducing chromosome breakage."( Cytogenetic toxicity of cyclophosphamide and its metabolites in vitro.
Arrighi, FE; Au, W; Kopnin, B; Sokova, OI, 1980
)
0.26
" Nevertheless, HN2 is extremely toxic and its use is accompanied by severe side-effects that may cause lung complications."( Toxic effects of mechlorethamine on mammalian respiratory mucociliary epithelium in primary culture.
Boivieux-Ulrich, E; Giuliani, I; Guennou, C; Houcine, O; Marano, F, 1994
)
0.63
" In contrast, tacrine was unable to significantly protect rat thymocytes against the toxic effects of sulphur mustard."( Modulation of mustard toxicity by tacrine.
Gray, P; Lewis, K; Masta, A; Phillips, D, 1994
)
0.29
"Cardiotoxicity is a well recognized side effect of anthracyclines (doxorubicin and epirubicin) or antracenadiones (mitoxantrone) at cumulative or high doses."( Late cardiac toxicity of doxorubicin, epirubicin, and mitoxantrone therapy for Hodgkin's disease in adults.
Arévila, N; Avilés, A; Díaz Maqueo, JC; García, R; Gómez, T; Nambo, MJ, 1993
)
0.29
" Animals were evaluated for toxic effects, including assessment of toxicant-induced alterations to the ocular and respiratory systems."( Acute inhalation toxicity of neutralized chemical agent identification sets (CAIS) containing agent in chloroform.
Johnson, R; McVeety, B; Morgan, EW; Olajos, EJ; Phelps, RL; Renne, RA; Salem, H,
)
0.13
" It is the authors' conclusion that the portable isolated limb perfusion system achieved all of the required parameters to provide safe and effective treatment for this type of melanoma."( Safe, compact and portable system for regional chemotherapeutic hyperthermic perfusion procedures.
Faddis, D; Fried, SJ; Miller, R; Weaver, FA, 1993
)
0.29
" Elsewhere, the oxidative stress appears to be a side effect in HN2 toxicity only upon considering the inefficiency of several antioxidants."( Protection from cytotoxic effects induced by the nitrogen mustard mechlorethamine on human bronchial epithelial cells in vitro.
Baeza-Squiban, A; Jeulin, C; Marano, F; Rappeneau, S, 2000
)
0.54
" At certain doses, highly acid solutions of nitrogen mustard show no toxic effects, while alkaline solutions at the same dose are invariably lethal."( Influence of pH on the toxicity of nitrogen mustard.
WHITE, LP, 1960
)
0.24
" These adverse effects on aquatic organisms caused by lower-level concentrations of HN2 indicate that a possible aquatic ecosystem disaster could occur either after a chemical spill or during chemical warfare."( Aquatic toxicity of nitrogen mustard to Ceriodaphina dubia, Daphnia magna, and Pimephales promelas.
Lan, CH; Lin, TS; Peng, CY, 2005
)
0.33
" While generally less toxic than sulfur mustards, these compounds have the potential for use as chemical warfare agents."( Ebselen protects brain, skin, lung and blood cells from mechlorethamine toxicity.
Billack, B; Hardej, D, 2007
)
0.59
" Single dose of 1 LD50 of nitrogen mustards and sulphur mustard was administered percutaneously and various oxidative stress parameters were also evaluated."( Comparison of toxicity of selected mustard agents by percutaneous and subcutaneous routes.
Ganesan, K; Sharma, M; Vijayaraghavan, R, 2008
)
0.35
"The majority of patients with Hodgkin's disease can be cured by combination of polychemotherapy and radiotherapy (RT) that can produce late toxic pulmonary and cardiac effects which often remain at a subclinical level."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"These data confirm that the combination of mediastinal RT with the more commonly used polychemotherapy regimens produce late toxic effects."( Cardiopulmonary toxicity of different chemoradiotherapy combined regimens for Hodgkin's disease.
Bonfante, V; Busia, A; Laffranchi, A; Villani, F; Viviani, S, 2010
)
0.36
"5% (adapalene-BPO) is efficacious and safe in the treatment of acne patients aged 12 years or older, as demonstrated in three randomized and controlled studies."( Treatment of 2,453 acne vulgaris patients aged 12-17 years with the fixed-dose adapalene-benzoyl peroxide combination topical gel: efficacy and safety.
Dirschka, T; Eichenfield, LE; Graeber, M; Jorizzo, JL; Kerrouche, N; Lynde, C; Taub, AF, 2010
)
0.36
" Tumor response and adverse events were assessed every month between months 1 and 6 and every 2 months between months 7 and 12."( Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides.
Adelson, DM; Duvic, M; Guitart, J; Hull, CM; Kim, EJ; Kim, YH; Kimball, AB; Knobler, EH; Lessin, SR; Naylor, MF; Olsen, EA; Pandya, AG; Rook, AH; Strober, BE; Sundram, U; Wood, GS; Wu, H, 2013
)
0.59
" No drug-related serious adverse events were seen."( Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides.
Adelson, DM; Duvic, M; Guitart, J; Hull, CM; Kim, EJ; Kim, YH; Kimball, AB; Knobler, EH; Lessin, SR; Naylor, MF; Olsen, EA; Pandya, AG; Rook, AH; Strober, BE; Sundram, U; Wood, GS; Wu, H, 2013
)
0.59
" The bifunctional electrophiles were capable of cross-linking Trx2 to itself in vitro and to other proteins in cells exposed to toxic concentrations."( Pronounced toxicity differences between homobifunctional protein cross-linkers and analogous monofunctional electrophiles.
Chandran, NN; Chowdhury, S; Daniel, AK; Herrin, RP; Radzinski, NP; Spencer, MK; Tripathi, S; West, JD, 2013
)
0.39
"Mustard is highly toxic to the lung."( The protective effect of melatonin and S-methylisothiourea treatments in nitrogen mustard induced lung toxicity in rats.
Aydin, I; Kenar, L; Korkmaz, A; Kunak, ZI; Macit, E; Onguru, O; Turel, S; Uysal, B; Yaman, H; Yaren, H, 2013
)
0.39
" These outcomes will add to our understanding of the toxic effects of topical vesicant exposure, which might be helpful towards developing effective countermeasures against injuries from acute topical exposures."( Topical nitrogen mustard exposure causes systemic toxic effects in mice.
Agarwal, C; Agarwal, R; Dhar, D; Goswami, DG; Inturi, S; Jain, AK; Kant, R; Kumar, D; Orlicky, DJ; Rancourt, RC; Tewari-Singh, N; White, CW, 2015
)
0.42
" Our earlier report has demonstrated the therapeutic efficacy of silibinin, a natural flavanone, in reversing monofunctional alkylating SM analog 2-chloroethyl ethyl sulfide-induced toxic effects in mouse skin."( Flavanone silibinin treatment attenuates nitrogen mustard-induced toxic effects in mouse skin.
Agarwal, C; Agarwal, R; Inturi, S; Jain, AK; Kumar, D; Orlicky, DJ; Tewari-Singh, N; White, CW, 2015
)
0.42
" Information evaluated included patient signalment, feline immunodeficiency virus/feline leukemia virus status, anatomic location(s) of lymphoma, prior protocols (type and number), MOPP doses, MOPP response, remission duration, hematologic and biochemical parameters, and owner-reported adverse effects."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.56
" The most common adverse effects were neutropenia and gastrointestinal upset, which were reported in 18."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.56
"MOPP is a safe protocol for the treatment of relapsed or refractory feline lymphoma, with a promising overall response rate and median remission time."( Efficacy and toxicity of mustargen, vincristine, procarbazine and prednisone (MOPP) for the treatment of relapsed or resistant lymphoma in cats.
Brown, DC; Krick, EL; MaloneyHuss, MA; Mauldin, GE; Veluvolu, SM, 2020
)
0.56
"Nitrogen mustard (NM) is a highly toxic alkylating agent."( Acute cytotoxicity and increased vascular endothelial growth factor after in vitro nitrogen mustard vapor exposure.
Kim, SY; McGraw, MD; Veress, LA; White, CW, 2020
)
0.56
" Adverse events (AE) were recorded in 43."( Chlormethine Gel is Efficient and Safe in Mycosis Fungoides Skin Lesions.
Dalamaga, M; Koumourtzis, M; Lampadaki, K; Papadavid, E, 2022
)
0.72
" CL gel has a manageable safety profile, with most adverse events being mild and skin related."( Chlormethine Gel for Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: A Review of Efficacy and Safety in Clinical Trial and Real-World Settings.
Ardigò, M; Nikbakht, N; Papadavid, E; Querfeld, C; Wehkamp, U, 2022
)
0.72

Compound-Compound Interactions

ExcerptReferenceRelevance
" All other disease stages will require a different strategy that should consist of radiotherapy combined with short-term effective regimens, such as ABVD (doxorubicin, bleomycin, vinblastine and decarbazine) or VBM (vinblastine, bleomycin and methotrexate) to reduce the incidence of MOPP-associated gonadal dysfunction and leukaemogenesis."( Early stage Hodgkin's disease: ten-year results of a non-randomised study with radiotherapy alone or combined with MOPP.
Banfi, A; Bonadonna, G; Bonfante, V; Devizzi, L; Santoro, A; Tesoro Tess, JD; Valagussa, P; Viviani, S; Zanini, M; Zucali, R, 1992
)
0.28
" It is noteworthy that in all subsets, ABVD (Adriamycin + bleomycin + vinblastine + dacarbazine), either combined with irradiation or alternated with MOPP (mechlorethamine + vincristine + procarbazine + prednisone), yielded superior results compared with MOPP with or without irradiation."( Prognosis of bulky Hodgkin's disease treated with chemotherapy alone or combined with radiotherapy.
Bonadonna, G; Santoro, A; Valagussa, P, 1985
)
0.47
"From 1976 to 1981, 335 patients with untreated Hodgkin's disease, clinical stages I, II, and IIIA, have been treated by MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) chemotherapy, three to six cycles according to the prognostic factors, combined with radiotherapy."( Extended versus involved fields irradiation combined with MOPP chemotherapy in early clinical stages of Hodgkin's disease.
Audebert, A; Bernadou, A; Diebold, J; Eghbali, H; Hoerni, B; Krulik, M; Merle-Béral, H; Parlier, Y; Rojouan, J; Zittoun, R, 1985
)
0.27
"Our objective was to analyze the effect of chlormethine gel in combination with other therapies on efficacy, safety, and health-related quality of life in a real-world setting."( The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma.
Akilov, OE; Angello, JT; Bailey, WL; Geskin, LJ; Girardi, M; Guitart, J; Kim, EJ; Musiek, A; Querfeld, C, 2021
)
0.86
" Chlormethine gel could be combined with other skin-directed or systemic therapies for optimal benefit."( Chlormethine Gel in Combination with Other Therapies in the Treatment of Patients with Mycosis Fungoides Cutaneous T Cell Lymphoma: Three Case Reports.
Karagianni, F; Koumourtzis, M; Lampadaki, K; Marinos, L; Papadavid, E, 2021
)
0.62

Bioavailability

ExcerptReferenceRelevance
" The effective combinations (L-TC + DOX, NAC + DOX, NAC + DMTU, NAC + HMT, NC + DOX) combined agents, reducing the bioavailability of the mustard with compounds possibly acting on the consequences of alkylation."( Efficient protection of human bronchial epithelial cells against sulfur and nitrogen mustard cytotoxicity using drug combinations.
Baeza-Squiban, A; Calvet, J; Marano, F; Rappeneau, S, 2000
)
0.31
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

The predictive value of mechlorethamine dosage with regard to OS was retained in an analysis restricted to the patients receiving greater than or equal to six cycles of chemotherapy. Combination chemotherapy of tumor bearing mice with thiamine and mechloreTHamine increased the mechloreThamine dosage required for a 50 to 60 percent increase in survival time.

ExcerptRelevanceReference
" The analysis consists of relating survival to the dosage level of each drug in the combination and using response surface techniques to determine the importance of drug interactions and to estimate optimal doses."( An improved method for analyzing survival data from combination chemotherapy experiments.
Carter, WH; Stablein, DM; Wampler, GL, 1979
)
0.26
" Methodology and dosage schemes are discussed."( Towards curative treatment of advanced Hodgkin's disease.
Falkson, G; Falkson, HC, 1975
)
0.25
" From a dose-response showing that the administration of increasing doses of tissue thromboplastin resulted in a subsequent progressive increase of thrombus weight, two concentrations of tissue thromboplastin were chosen: a high dose (550 microL/kg, IV) where thrombus formation was optimal and a concentration (7 microL/kg, IV) where tissue thromboplastin-hypercoagulability was intermediate."( Importance of platelets in experimental venous thrombosis in the rat.
Bernat, A; Herbert, JM; Maffrand, JP, 1992
)
0.28
" In a multivariate analysis where both disease-related and treatment-related factors were taken into account drug dosage remained a significant prognostic factor."( Treatment of Hodgkin's disease with MOPP chemotherapy: effect of dose and schedule modification on treatment outcome.
Bezwoda, MA; Bezwoda, WR; Dansey, R, 1990
)
0.28
" The predictive value of mechlorethamine dosage with regard to OS was retained in an analysis restricted to the patients receiving greater than or equal to six cycles of chemotherapy."( Dose intensity of MOPP chemotherapy and survival in Hodgkin's disease.
de Meijer, AJ; Dekker, AW; Haanen, C; van Rijswijk, RE; Verbeek, J, 1989
)
0.58
" One may hope that this dosage of mechlorethamine will not be gonadotoxic."( [Value of chlormethine in children with corticoid-dependent or partially corticoid-sensitive nephrosis, in steroid poisoning].
Loirat, C; Macher, MA; Maisin, A; Mathieu, H; Pillion, G,
)
0.41
" Buserelin (d-Ser-[TBU]6 LHRH ethylamide) was prescribed in two different dosage schedules to twenty men, and in a single dosage schedule to eight women."( Failure to preserve fertility in patients with Hodgkin's disease.
Ahmed, R; Besser, GM; Crowther, D; Gregory, W; Malpas, JS; Rees, LH; Shalet, S; Smith, D; Waxman, JH; Wrigley, PF, 1987
)
0.27
" Thiosulfate dosing studies showed that a molar excess of at least 200:1 (Na2S2O3:HN2) was required for significant antidotal activity."( Efficacy of sodium thiosulfate as a local antidote to mechlorethamine skin toxicity in the mouse.
Alberts, DS; Dorr, RT; Soble, M, 1988
)
0.52
" The dose-response relationship for the potentiation was defined for DMSO."( Potentiation of nitrogen mustard cytotoxicity to leukemia cells by sulfur-containing compounds administered in vivo.
Grates, HE; Valeriote, F, 1986
)
0.27
" Demonstration of systemic signs, bioptically confirmed bone-marrow infiltration and suboptimal cytostatic dosage correlated significantly with a lower full-remission rate."( [Chemotherapy of advanced lymphogranulomatosis. Results of MOPP/COPP treatment at the West German Tumor Center, Essen].
Becher, R; Höffken, K; Ippisch, A; Pfeiffer, R; Schmidt, CG; Seeber, S, 1985
)
0.27
" In the absence of evidence of a dose-response curve for platinum, the lower dosage schedules that can be used with acceptable toxicity on an outpatient basis should be selected."( Chemotherapy for squamous cell carcinoma of the head and neck: a progress report.
Glick, JH; Taylor, SG; Zehngebot, LM, 1980
)
0.26
" From 1976 to 1979 patients with Stage IV disease were treated wither with MOPP or with MOPP plus bleomycin at low dosage (B-MOPP); the incidence of complete remission was not significantly different in the two groups of patients (52 vs."( Combination chemotherapy for stage IV Hodgkin's disease (Report no 14).
Goldman, JM, 1981
)
0.26
" Induced mutant frequency increased linearly with increasing dose whereas dose-response curves for cytotoxicity for these effective mutagens invariably showed a shoulder followed by an exponential decline."( Relative mutagenicity of antineoplastic drugs and other alkylating agents in V79 Chinese hamster cells, independence of cytotoxic and mutagenic responses.
Brennand, J; Fox, M; McMillan, S; Suter, W, 1980
)
0.26
" Dose-response relationships for delay in cell cycle progression were measured using flow cytometry."( DNA repair, DNA synthesis and cell cycle delay in human lymphoblastoid cells differentially sensitive to the cytotoxic effects of nitrogen mustard.
Dean, SW; Fox, M,
)
0.13
" Cytostatics are dosed per liter of perfused extremity."( [Technic of isolated perfusion of the extremities. Experience with 171 cases].
Aigner, K; Schwemmle, K, 1983
)
0.27
"A dose-response analysis of the results of MOPP chemotherapy in 132 patients with Hodgkin's disease was carried out."( A dose and time response analysis of the treatment of Hodgkin's disease with MOPP chemotherapy.
Carde, P; MacKintosh, FR; Rosenberg, SA, 1983
)
0.27
" A comparison of drug dosage in the group receiving TPN and the group receiving standard nutrition is a measure of drug tolerance in these patients."( A prospective randomized study of adjuvant parenteral nutrition in the treatment of diffuse lymphoma: effect on drug tolerance.
Brennan, MF; Fisher, RI; Popp, MB; Simon, RM, 1981
)
0.26
" The planned dosage intensity had to be significantly reduced in over half of the patients because of marrow toxicity."( Measurement of drug dosage intensity in MVPP therapy in Hodgkin's disease.
Dawson, AA; Fell, LF; Green, JA; Murray, S, 1980
)
0.26
" A dose-response effect was noted with both BCNU and adriamycin, with increased potentiation being observed with increasing doses of the anticancer agents."( Potentiation of anticancer agents by amphotericin B.
Dieckman, J; Medoff, G; Valeriote, F, 1981
)
0.26
" Dose-response experiments performed with 2 to 90 per cent (v/v) zymosan-activated plasma showed a direct correlation between the rate of neutrophil influx and the degree of vascular permeability in blood flow."( Vascular responses during acute neutrophilic inflammation. Their relationship to in vivo neutrophil emigration.
Issekutz, AC, 1981
)
0.26
" Combination chemotherapy of tumor bearing mice with thiamine and mechlorethamine increased the mechlorethamine dosage required for a 50 to 60 percent increase in survival time but did not improve survival over that obtained with mechlorethamine alone."( Thiamine protection of murine L1210 leukemia cells against mechlorethamine cytotoxicity and its relation to the choline uptake system.
Naujokaitis, SA, 1981
)
0.74
" However, most workers in the field acknowledge that issues of optimal dosing and curative potency remain unresolved."( Total skin electron irradiation: efficacy in early mycosis fungoides.
Dale, J; Kuten, A; Leviov, M; Rosenblatt, E; Tatcher, M, 1993
)
0.29
" In rats dosed with SR 4233 in vivo, significantly higher levels of 8-hydroxydeoxyguanosine could be detected in liver, compared to vehicle-dosed controls."( Genotoxic effects of 3-amino-1,2,4-benzotriazine-1,4-dioxide (SR 4233) and nitrogen mustard-N-oxide (nitromin) in Walker carcinoma cells under aerobic and hypoxic conditions.
Cahill, A; Jenkins, TC; Pickering, P; White, IN, 1995
)
0.29
" MCHT administered at a dose of 600 micrograms/kg suppresses humoral response of the immunized rats both after a single dosage and five days' treatment at 24 hours intervals."( Modulation of humoral response in rats by levamisole, mechlorethamine and sodium diethyldithiocarbamate.
Całkosiński, I; Obmińska-Domoradzka, B, 1994
)
0.54
" Comparison of the dose-response relationships for humans and rats indicates that, under conditions of no depletion of O6-alkylguanine-DNA alkyltransferase (AGT), O6-meG accumulates in blood leukocyte DNA of humans at a rate which is only approximately 2-fold lower than in rats, implying that, to the extent to which O6-meG contributes to the genotoxic activity of procarbazine, human susceptibility to it is likely to be comparable to that of the rat."( Comparative dosimetry of O6-methylguanine in humans and rodents treated with procarbazine.
Boussiotis, VA; Kyrtopoulos, SA; Pangalis, GA; Souliotis, VL; Valavanis, C, 1994
)
0.29
" Using this assay in the present study, dose-response relationships of cytotoxicity, PFC response and histology in the spleen were evaluated in rats receiving alkylating agents."( Dose-response relationships of cytotoxicity, PFC response and histology in the spleen in rats treated with alkylating agents.
Doi, T; Nagai, H; Suzuki, T; Tsukuda, R, 1996
)
0.29
" Animals were dosed topically with 'test article'--neat HD, 10% agent/chloroform solutions or product solutions (waste-streams) from neutralized CAIS--and evaluated for skin-damaging effects (gross and microscopic)."( Evaluation of neutralized chemical agent identification sets (CAIS) for skin injury with an overview of the vesicant potential of agent degradation products.
Hayes, TL; MacIver, B; Menton, RG; Miller, TL; Olajos, EJ; Olson, CT; Rosso, T; Salem, H; Singer, AW,
)
0.13
" US Food and Drug Administration (FDA)-approved, oral systemic bexarotene has the advantage of a 48% overall response rate at a dosage of 300 mg/m(2)/day, and avoids immunosuppression and risk of central line and catheter-related infectious complications that are associated with other systemic therapies."( Treatment of cutaneous T cell lymphoma: current status and future directions.
Apisarnthanarax, N; Duvic, M; Talpur, R, 2002
)
0.31
"From February, 1997 to December, 1997 11 patients with oral cancer (9 cases with lingual carcinoma, 2 cases with mouth carcinoma) were received one-shot chemotherapy during operation by NH2 catheterizing of lingual arteries (concentration of 1 mg/ml, dosage of 5 mg), and the other 16 oral cancer patients (13 cases with lingual carcinoma, 3 cases with mouth carcinoma) were only received operation as the control."( [Clinical effects of intra-arterial nitrogen mustard (NH2) chemotherapy during operation for oral cancer].
Guo, W; He, Y; Zhang, C; Zhang, Z; Zhu, H, 2000
)
0.31
" Timing and dosage are also considered."( SOME PROBLEMS IN THE CHEMOTHERAPY OF SOLID TUMOURS.
ARONOVITCH, M; GROSZMAN, M; KAHANA, LM, 1964
)
0.24
" The improved method was used to measure levels of the urinary metabolites N-ethyldiethanolamine (EDEA), N-methyldiethanolamine (MDEA), and triethanolamine (TEA) in rats dosed with HN1, HN2, and HN3, respectively, and to establish background levels of EDEA, MDEA, and TEA in human urine samples from a population with no known exposure to nitrogen mustards."( Quantitation of biomarkers of exposure to nitrogen mustards in urine from rats dosed with nitrogen mustards and from an unexposed human population.
Ashley, DL; Barr, JR; Hayes, TL; Lemire, SW; Olson, CT,
)
0.13
" Since survival rates for patients receiving risk-adapted programs (DAL-Hd, SPBLKH-05) were higher than in control (MOPP), relevant protocols using lower drug dosage should be recommended in groups of favorable and intermediate risk."( [Use of risk-adapted programs of treatment of Hodgkin's disease in children and adolescents].
Kuleva, SA, 2008
)
0.35
" It is suggested that total focal dosage used after chemotherapy be reviewed since total dosage for the entire lymph collector in excess of 30 Gy might contribute to hazards of cardiopathology."( [Multivariate analysis of risk of cardiac complications in Hodgkin's lymphoma].
Bozhenko, VK; Datsenko, PV; Ivashin, AV; Mel'nik, IuD; Pan'shin, GA; Podol'skiĭ, PN; Sotnikov, VM, 2009
)
0.35
"A gas chromatographic-mass spectrometric method was developed, validated and demonstrated by measuring the levels of nitrogen mustard hydrolysis products in the urine collected from dosed rats."( Determination of nitrogen mustard hydrolysis products in rat urine samples using GC-MS.
Alp, O; Kenar, L, 2011
)
0.37
" Prospective pharmacokinetic studies to devise a rational dosing strategy for vinblastine in patients receiving ritonavir/lopinavir are warranted."( Incidence, predictors and significance of severe toxicity in patients with human immunodeficiency virus-associated Hodgkin lymphoma.
Boro, J; Cheung, MC; Ezzat, HM; Harris, M; Hicks, LK; Leitch, HA; Lima, VD; Montaner, JS, 2012
)
0.38
" Repeat dosing with 25(OH)D at 48 h and beyond led to marked improvement of lesion size with 75% recovery from mortality."( Defining the timing of 25(OH)D rescue following nitrogen mustard exposure.
Binko, AM; Das, LM; Duesler, L; Lu, KQ; Traylor, ZP, 2018
)
0.48
" However, modifications such as repeat dosing can be an effective strategy to extend the intervention potential of 25(OH)D."( Defining the timing of 25(OH)D rescue following nitrogen mustard exposure.
Binko, AM; Das, LM; Duesler, L; Lu, KQ; Traylor, ZP, 2018
)
0.48
" Off-label dosing modifications, as well as co-administration of topical steroids and an aggressive moisturization regimen, can be used to reduce these side-effects."( Management of Mycosis Fungoides with Topical Chlormethine/Mechlorethamine Gel: A Columbia University Cutaneous Lymphoma Center Experience.
Garcia-Saleem, TJ; Geskin, LJ; Khaleel, AE; Stonesifer, CJ, 2021
)
0.87
" The effects of NM-exposure to eyes may include irritation, redness, inflammation, fibrosis, epithelial degradation, blurred vision, partial/complete blindness, which may be temporary or permanent, depending on the route, duration, and dosage of exposure."( Effect of dexamethasone treatment at variable therapeutic windows in reversing nitrogen mustard-induced corneal injuries in rabbit ocular in vivo model.
Agarwal, C; Agarwal, R; Ammar, DA; Goswami, DG; Kant, R; Mishra, N; Petrash, JM; Tewari-Singh, N, 2022
)
0.72
" However, the optimal regimen regarding frequency and dosing as well as combination and maintenance therapy is not well established."( The optimal use of chlormethine gel for mycosis fungoides: An expert consensus from Germany, Austria and Switzerland (DACH region).
Assaf, C; Booken, N; Dippel, E; Guenova, E; Jonak, C; Klemke, CD; Nicolay, JP; Schlaak, M; Trautinger, F; Wobser, M, 2022
)
0.72
" SM can cause devastating injuries, depending on the dosage of SM exposure, route of exposure, as well as the physiological conditions of the individuals exposed."( Research models of sulfur mustard- and nitrogen mustard-induced ocular injuries and potential therapeutics.
Agarwal, R; Mishra, N, 2022
)
0.72
" Peak edema occurred 24-48 h after NM administration using optimized dosing methods and volume."( Depilatory double-disc mouse model for evaluation of vesicant dermal injury pharmacotherapy countermeasures.
Gao, D; Laskin, JD; Li, S; Roldan, TL; Sinko, PJ, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
alkylating agentHighly reactive chemical that introduces alkyl radicals into biologically active molecules and thereby prevents their proper functioning. It could be used as an antineoplastic agent, but it might be very toxic, with carcinogenic, mutagenic, teratogenic, and immunosuppressant actions. It could also be used as a component of poison gases.
[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 (2)

ClassDescription
nitrogen mustardCompounds having two beta-haloalkyl groups bound to a nitrogen atom, as in (X-CH2-CH2)2NR.
organochlorine compoundAn organochlorine compound is a compound containing at least one carbon-chlorine bond.
[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 (8)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Fumarate hydrataseHomo sapiens (human)Potency33.17340.00308.794948.0869AID1347053
PPM1D proteinHomo sapiens (human)Potency46.61280.00529.466132.9993AID1347411
TDP1 proteinHomo sapiens (human)Potency22.14270.000811.382244.6684AID686978; AID686979
Microtubule-associated protein tauHomo sapiens (human)Potency35.48130.180013.557439.8107AID1460
EWS/FLI fusion proteinHomo sapiens (human)Potency34.52270.001310.157742.8575AID1259252; AID1259253; AID1259255
polyproteinZika virusPotency33.17340.00308.794948.0869AID1347053
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency11.22020.00798.23321,122.0200AID2551
Interferon betaHomo sapiens (human)Potency46.61280.00339.158239.8107AID1347411
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (30)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (5)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (2)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (143)

Assay IDTitleYearJournalArticle
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
AID229938Hypersensitivity factor which is a ratio of IC50 of AA8 cells to that of the UV4 cells1993Journal of medicinal chemistry, Aug-20, Volume: 36, Issue:17
Nitrobenzyl mustard quaternary salts: a new class of hypoxia-selective cytotoxins showing very high in vitro selectivity.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID9681Concentration for 50% inhibition of AA8 cells growth under aerobic conditions after 18 hours exposure1993Journal of medicinal chemistry, Aug-20, Volume: 36, Issue:17
Nitrobenzyl mustard quaternary salts: a new class of hypoxia-selective cytotoxins showing very high in vitro selectivity.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID409956Inhibition of mouse 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.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID215463Ability to reduce cell density of UV4 cells to 50% after 4 hr of exposure to air2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID67761Ability to reduce cell density of EMT6 cells to 50% after 4 hr of exposure to air2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID23271Partition coefficient (logD7.4)1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
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.
AID67631Ability to reduce surviving fraction of EMT6 cells to 10% when exposed to air for 3 hrs2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID124094in vivo activity against aerobic and hypoxic cells in RIF-1 tumors when administered at a dose of 17.8 umol/kg in mice2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID29853Rate of breakdown of mechlorethamine in the presence of GSH was tested and the half life period was determined at 30 degrees Celsius at pH 71990Journal of medicinal chemistry, Mar, Volume: 33, Issue:3
NMR studies of the conjugation of mechlorethamine with glutathione.
AID45400Effect on cross resistance of CHO cells resistant to colchicine (CHRC5)1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
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.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID67630Ability to reduce surviving fraction of EMT6 cells to 10% when exposed to N2 for 3 hrs2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID409954Inhibition of mouse 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.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID124095in vivo activity against aerobic and hypoxic cells in RIF-1 tumors when administered at a dose of 17.8 umol/kg in mice 30 min before exposure to radiation2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID288401Growth inhibition of human DU145 cells after 3 days by SRB assay2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Novel nitrogen mustard-armed combi-molecules for the selective targeting of epidermal growth factor receptor overexperessing solid tumors: discovery of an unusual structure-activity relationship.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID9678Ability to reduce cell density of AA8 cells to 50% after 4 hr of exposure to air2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID596310Toxicity in mouse harboring P-388 cells2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
3,5-Bis(benzylidene)-1-[3-(2-hydroxyethylthio)propanoyl]piperidin-4-ones: a novel cluster of potent tumor-selective cytotoxins.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID67632Hypoxic cytotoxicity ratio was determined2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID67623Hypersensitivity factor is the ratio of IC50 for AA8/IC50 for EMT6 cell line1996Journal of medicinal chemistry, Mar-01, Volume: 39, Issue:5
Hypoxia-selective antitumor agents. 12. Nitrobenzyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID51924Effect on cross resistance of chinese hamster cells resistant to Actinomycin D.1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
Structure-activity relationships of antineoplastic agents in multidrug resistance.
AID1150113Displacement of 2 x 10'-8 M of [1,2,3-3H]-triamcinolone acetonide from glucocorticoid receptor in soluble fraction of mouse L929 cells after 20 hrs1977Journal of medicinal chemistry, Sep, Volume: 20, Issue:9
Synthesis and biological action of two glucocorticoid alkylating agents.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID101608The compound was evaluated for cytotoxicity by assessing 3H thymidine uptake in MCF-7 cell line2000Bioorganic & medicinal chemistry letters, Sep-04, Volume: 10, Issue:17
Towards enzyme activated antiprostatic agents.
AID9488Cytotoxicity against AA8 cell and IC50 values were determined as drug concentration required to inhibit cell protein to 50%.1996Journal of medicinal chemistry, Mar-01, Volume: 39, Issue:5
Hypoxia-selective antitumor agents. 12. Nitrobenzyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID124096in vivo activity against aerobic and hypoxic cells in RIF-1 tumors when administered at a dose of 17.8 umol/kg in mice after 5 min of exposure to radiation2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID288406Induction of cell cycle arrest in human DU145 cells assessed as accumulation at mid-S phase at 10 uM after 24 hrs by flow cytometry2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Novel nitrogen mustard-armed combi-molecules for the selective targeting of epidermal growth factor receptor overexperessing solid tumors: discovery of an unusual structure-activity relationship.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
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.
AID100394The compound was evaluated for cytotoxicity by assessing 3H thymidine uptake in LNCaP cell line2000Bioorganic & medicinal chemistry letters, Sep-04, Volume: 10, Issue:17
Towards enzyme activated antiprostatic agents.
AID205119Ability to reduce cell density of SKOV3 cells to 50% after 4 hr of exposure to air2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID409957Inhibition of bovine liver 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.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID29852Rate of breakdown of mechlorethamine in 0.05 M phosphate buffer was tested and the half life period was determined at 30 degrees Centigrade at pH 71990Journal of medicinal chemistry, Mar, Volume: 33, Issue:3
NMR studies of the conjugation of mechlorethamine with glutathione.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1150116Alkylating activity of the compound assessed as alkylation of 4-(p-nitrobenzyl)pyridine at 2 x 10'-5 M after 20 mins by colorimetric analysis1977Journal of medicinal chemistry, Sep, Volume: 20, Issue:9
Synthesis and biological action of two glucocorticoid alkylating agents.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
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.
AID1145410Stability of the compound at pH 4.181976Journal of medicinal chemistry, May, Volume: 19, Issue:5
Synthesis and anticancer activity of 5-diethylaminomethyl derivatives and nitrogen mustards of uracil and 2-thiouracils.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1145409Dissociation constant, pKa of the compound1976Journal of medicinal chemistry, May, Volume: 19, Issue:5
Synthesis and anticancer activity of 5-diethylaminomethyl derivatives and nitrogen mustards of uracil and 2-thiouracils.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID596309Toxicity in mouse harboring L1210 cells2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
3,5-Bis(benzylidene)-1-[3-(2-hydroxyethylthio)propanoyl]piperidin-4-ones: a novel cluster of potent tumor-selective cytotoxins.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID215304Hypersensitivity factor is the ratio of IC50 for AA8/IC50 for UV4 cell line1996Journal of medicinal chemistry, Mar-01, Volume: 39, Issue:5
Hypoxia-selective antitumor agents. 12. Nitrobenzyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID115134In vivo toxicity against C3H/HeN cell line in mice expressed as maximal tolerated dose2001Journal of medicinal chemistry, Oct-11, Volume: 44, Issue:21
Hypoxia-selective antitumor agents. 16. Nitroarylmethyl quaternary salts as bioreductive prodrugs of the alkylating agent mechlorethamine.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (5,192)

TimeframeStudies, This Drug (%)All Drugs %
pre-19904003 (77.10)18.7374
1990's616 (11.86)18.2507
2000's273 (5.26)29.6817
2010's219 (4.22)24.3611
2020's81 (1.56)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 48.31

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index48.31 (24.57)
Research Supply Index8.70 (2.92)
Research Growth Index4.30 (4.65)
Search Engine Demand Index83.81 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (48.31)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials336 (5.96%)5.53%
Reviews254 (4.51%)6.00%
Case Studies346 (6.14%)4.05%
Observational2 (0.04%)0.25%
Other4,698 (83.36%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (102)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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.)
A Phase I/II Clinical Trial of NK Cells Administration to Prevent Disease Relapse for Patient With High-Risk Myeloid Malignancies Undergoing Haploidentical Stem-Cell Transplantation [NCT01904136]Phase 1/Phase 290 participants (Anticipated)Interventional2014-04-22Completed
Phase II Study of RO4929097 to Eradicate Residual Disease in Patients With Multiple Myeloma Post Single Autologous Stem Cell Transplant [NCT01251172]Phase 20 participants (Actual)Interventional2010-12-31Withdrawn(stopped due to Lack of Drug Supply)
Phase IIa Study of Addition of Itacitinib With Tacrolimus/Sirolimus Regimen for GVHD Prophylaxis in Fludarabine and Melphalan Non-Myeloablative Conditioning Hematopoietic Cell Transplantation for Acute Leukemias, MDS or MF [NCT04339101]Phase 259 participants (Actual)Interventional2020-11-11Active, not recruiting
IIS: Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides [NCT03288818]Phase 20 participants (Actual)Interventional2018-08-31Withdrawn(stopped due to Funding discontinued)
Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients With Newly Diagnosed High-Risk Neuroblastoma [NCT01798004]Phase 1150 participants (Actual)Interventional2013-04-08Active, not recruiting
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
A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma [NCT01175356]Phase 199 participants (Actual)Interventional2010-10-04Active, not recruiting
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
Pilot Study of HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL [NCT06149247]Phase 210 participants (Anticipated)Interventional2023-12-05Recruiting
Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived CAR-NK Cells Combined With High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-Cell Lymphoma [NCT03579927]Phase 1/Phase 20 participants (Actual)Interventional2019-10-03Withdrawn(stopped due to Lack of Funding)
Phase I/II Study of Carboplatin, Melphalan and Etoposide Phosphate in Conjunction With Osmotic Opening of the Blood-Brain Barrier and Delayed Intravenous Sodium Thiosulfate Chemoprotection, in Previously Treated Subjects With Anaplastic Oligodendroglioma [NCT00303849]Phase 1/Phase 233 participants (Actual)Interventional2005-09-15Completed
A Phase II Study of Enhancing Anti-Tetanus Vaccine Response After Autologous Stem Cell Transplantation [NCT02700841]Phase 28 participants (Actual)Interventional2020-01-09Terminated(stopped due to Study terminated prematurely due to poor recruitment.)
Reduce Intensity Conditioning (RIC) Allogenic Hematopoietic Stem Cell Transplantation (Allo HSCT) for Patients With Relapsed Multiple Myeloma: A Pilot Study [NCT04205240]Phase 21 participants (Actual)Interventional2020-12-22Terminated(stopped due to Poor accrual)
Adoptive Transfer of NY-ESO-1 TCR Engineered Peripheral Blood Mononuclear Cells (PBMC) and Peripheral Blood Stem Cells (PBSC) After a High Dose Melphalan Conditioning Regimen, With Administration of Interleukin-2, in Patients With Multiple Myeloma [NCT03506802]Phase 10 participants (Actual)Interventional2018-07-10Withdrawn(stopped due to No Participants Enrolled)
Intravitreal Melphalan for Intraocular Retinoblastoma [NCT05504291]Phase 228 participants (Anticipated)Interventional2022-11-04Recruiting
A Multi-Center, Phase 3, Randomized Trial of Matched Unrelated Donor (MUD) Versus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia or Myelodysplastic [NCT05457556]Phase 3435 participants (Anticipated)Interventional2023-03-15Recruiting
An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(TM))(MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose T [NCT00602641]Phase 3306 participants (Actual)Interventional2008-02-29Active, not recruiting
A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma [NCT00114101]Phase 3460 participants (Actual)Interventional2004-12-15Active, not recruiting
Valchlor in the Treatment of Lichen Planopilaris: A Single Arm, Open- Label, Exploratory Study [NCT03417141]Phase 212 participants (Actual)Interventional2018-04-01Completed
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
Post-Transplant Bendamustine (PT-BEN) for GVHD Prophylaxis [NCT04022239]Phase 1/Phase 240 participants (Anticipated)Interventional2020-03-13Recruiting
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 II Study of Umbilical Cord Blood-Derived Natural Killer Cells in Conjunction With Elotuzumab, Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma [NCT01729091]Phase 272 participants (Anticipated)Interventional2013-06-10Active, not recruiting
Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease [NCT00002462]Phase 3615 participants (Actual)Interventional1989-09-30Active, not recruiting
A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma [NCT06172296]Phase 3478 participants (Anticipated)Interventional2024-02-14Not yet recruiting
A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas [NCT02130869]Phase 18 participants (Actual)Interventional2014-10-10Completed
A Phase I, Open Label Study Evaluating the Safety and Efficacy of Adoptive Transfer of Autologous NY-ESO-1 CD8-TCR Engineered T Cells and NY-ESO-1 CD4-TCR Engineered Hematopoietic Stem Cells (HSC) After a Myeloablative Conditioning Regimen, With Administr [NCT03691376]Phase 14 participants (Actual)Interventional2019-03-08Active, not recruiting
An Exploratory, Single-centre, Two-part Study to Describe Mycosis Fungoides Characteristics and Explore Novel Biomarkers With a Multi- Modal Patient Profiling Approach by Comparing MF Patients to Healthy Volunteers [NCT05303480]32 participants (Actual)Interventional2021-12-07Completed
A Reduced Intensity Conditioning Regimen With CD3-Depleted Hematopoietic Stem Cells to Improve Survival for Patients With Hematologic Malignancies Undergoing Haploidentical Stem Cell Transplantation [NCT00566696]Phase 273 participants (Actual)Interventional2007-12-14Completed
To Assess the Efficacy of Mustard Oil and Salt Massage as an Adjunct to Scaling and Root Planing in Patients With Chronic Periodontitis: A Clinical Study [NCT02638740]54 participants (Actual)Interventional2015-06-30Completed
A Multi-institutional Feasibility Study of Intra-arterial Chemotherapy Given in the Ophthalmic Artery of Children With Retinoblastoma [NCT02097134]Phase 114 participants (Actual)Interventional2014-10-31Completed
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma [NCT00352027]Phase 281 participants (Actual)Interventional2006-07-20Completed
Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake [NCT00841893]16 participants (Actual)Interventional2008-08-31Completed
A Pilot Induction Regimen Incorporating Chimeric 14.18 Antibody (ch14.18, Dinutuximab) (NSC# 764038) and Sargramostim (GM-CSF) for the Treatment of Newly Diagnosed High-Risk Neuroblastoma [NCT03786783]Phase 242 participants (Actual)Interventional2019-01-14Active, not recruiting
Addition of Inotuzumab Ozogamicin Pre- and Post-Allogeneic Transplantation [NCT03856216]Phase 244 participants (Anticipated)Interventional2019-10-28Recruiting
Phase I/II Study of Intra-Arterial Melphalan Given With Intra-Arterial Carboplatin, Osmotic Blood-Brain Barrier Disruption and Delayed Otoprotective Sodium Thiosulfate for Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors [NCT00983398]Phase 1/Phase 217 participants (Actual)Interventional2009-07-09Active, not recruiting
A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients [NCT00899847]Phase 29 participants (Actual)Interventional2009-05-31Completed
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma [NCT00567567]Phase 3665 participants (Actual)Interventional2007-11-05Completed
Maximising the Bioavailability and Activity of Broccoli Phytochemicals Using a Broccoli Soup Enriched for Myrosinase by Addition of Mustard Seeds [NCT04113928]20 participants (Actual)Interventional2015-03-23Completed
Bortezomib (Velcade®) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies [NCT00439556]Phase 240 participants (Actual)Interventional2007-02-13Completed
A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF) [NCT00168064]Phase 2260 participants (Actual)Interventional2006-05-31Completed
Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma [NCT02506959]Phase 283 participants (Actual)Interventional2015-09-14Active, not recruiting
Personalized NK Cell Therapy in CBT [NCT02727803]Phase 2100 participants (Anticipated)Interventional2016-05-19Recruiting
A Phase I Study of Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-Selected CD34+ Cells [NCT02797470]Phase 1/Phase 211 participants (Actual)Interventional2016-06-23Active, not recruiting
A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype [NCT02443077]Phase 3302 participants (Anticipated)Interventional2016-10-12Active, not recruiting
A Phase I Trial Evaluating Escalating Doses of 211At-Labeled Anti-CD38 Monoclonal Antibody (211At-OKT10-B10) Combined With Melphalan as Conditioning Prior to Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma [NCT04466475]Phase 130 participants (Anticipated)Interventional2024-01-27Recruiting
Phase II Study of Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides [NCT02881749]Phase 268 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Bortezomib* and Vorinostat as Maintenance Therapy After Autologous Transplant for Non-Hodgkin Lymphoma Using R-BEAM or BEAM Conditioning Transplant Regimen [NCT00992446]Phase 227 participants (Actual)Interventional2010-09-02Completed
A Multicenter, Open-Label, Single Arm, Phase II Study of Daratumumab as Consolidation/Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma [NCT03346135]Phase 231 participants (Actual)Interventional2019-07-17Active, not recruiting
Loncastuximab Tesirine in Combination With BEAM (Carmustine, Etoposide, Ara-C, Melphalan) Conditioning Regimen Prior to Autologous Stem Cell Transplant (ASCT) and for Maintenance Therapy in Diffuse Large B-Cell Lymphoma (DLBCL) [NCT05228249]Phase 10 participants (Actual)Interventional2023-04-30Withdrawn(stopped due to PI left institution and funding sponsor closed study. Study did not open to accrual, and no participants were enrolled.)
Phase I/II Study of Lenalidomide Maintenance Following BEAM (+/- Rituximab) for Chemo-Resistant or High Risk Non-Hodgkin?s Lymphoma [NCT01035463]Phase 1/Phase 274 participants (Actual)Interventional2009-11-12Completed
A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloid [NCT06022939]Phase 3338 participants (Anticipated)Interventional2023-10-31Not yet recruiting
An Open Label Study to Evaluate the Safety and Efficacy of Nitrogen Mustard (Mechlorethamine - MCH) 0.04% Formulation in Patients With Stage I-IIA Mycosis Fungoides Who Have Completed 12 Months Treatment Without a Complete Response [NCT00535470]Phase 2100 participants (Actual)Interventional2007-07-31Completed
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers - a Blinded, Randomized, Controlled, Four-Arm Study With Crossover Design [NCT04321720]16 participants (Actual)Interventional2020-04-20Completed
Cord Blood Ex-Vivo MSC Expansion Plus Fucosylation to Enhance Homing and Engraftment [NCT03096782]Phase 26 participants (Actual)Interventional2017-10-13Completed
A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma [NCT00004188]Phase 3495 participants (Actual)Interventional2001-02-28Completed
A Pilot Study of Reduced Intensity HLA-Haploidentical Hematopoietic Cell Transplantation With Post-Transplant Cyclophosphamide in Patients With Advanced Myelofibrosis [NCT03118492]Phase 116 participants (Anticipated)Interventional2017-05-24Recruiting
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
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 II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE [NCT00002714]Phase 20 participants Interventional1995-04-30Completed
Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease [NCT00041210]Phase 3850 participants (Anticipated)Interventional2001-10-31Active, not recruiting
A Phase I/II Trial of Venetoclax and BEAM Conditioning Followed by Autologous Stem Cell Transplantation for Patients With Primary Refractory Non-Hodgkin Lymphoma [NCT03583424]Phase 1/Phase 219 participants (Actual)Interventional2018-09-10Active, not recruiting
Phase I Study of Escalating Doses of Total Marrow and Lymphoid Irradiation (TMLI) Combined With Fludarabine and Melphalan as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndro [NCT03494569]Phase 136 participants (Anticipated)Interventional2018-07-06Recruiting
Bioavailability of Sulforaphane From a Glucoraphanin-Rich Broccoli Seed Supplement With or Without Added Myrosinase From Mustard Seed Powder [NCT04946526]16 participants (Actual)Interventional2022-06-01Completed
"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
Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis [NCT04384692]Phase 245 participants (Anticipated)Interventional2020-12-18Recruiting
Olaparib Combined With High-Dose Chemotherapy for Refractory Lymphomas [NCT03259503]Phase 150 participants (Actual)Interventional2019-09-13Active, not recruiting
A PROspective, Observational, US-based Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma and Treated With Valchlor® [NCT02296164]300 participants (Actual)Observational [Patient Registry]2014-11-12Completed
Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation [NCT02960646]Phase 111 participants (Actual)Interventional2017-01-18Completed
Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2) [NCT01588756]Phase 1/Phase 2100 participants (Actual)Interventional2010-10-31Completed
Natural Killer Cells in Allogeneic Cord Blood Transplantation [NCT01619761]Phase 113 participants (Actual)Interventional2013-05-03Active, not recruiting
A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas [NCT01625351]Phase 123 participants (Actual)Interventional2012-08-20Completed
Phase I-II Single Cycle Melphalan/Total Marrow Irradiation (TMI) and Autologous Stem Cell Transplantation (ASCT) Followed by Maintenance in Patients With High-Risk Myeloma and/or Poor Response to Induction Therapy Within 12 Months of Diagnosis [NCT03100877]Phase 1/Phase 20 participants (Actual)Interventional2018-01-31Withdrawn(stopped due to Feasibility Issues)
Triamcinolone Acetonide Injections in Primary Cutaneous Lymphoma Plaques With a Novel Needle-free Drug-delivery System. [NCT05106192]22 participants (Anticipated)Interventional2024-06-01Not yet recruiting
The Effect of Oral Vitamin D (Cholecalciferol) Supplementation After Topical Application With Valchlor [NCT02968446]Early Phase 133 participants (Actual)Interventional2016-11-17Completed
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
Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies [NCT01807611]Phase 282 participants (Actual)Interventional2013-05-16Completed
Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma [NCT00002463]Phase 24 participants (Actual)Interventional1989-02-28Completed
A Phase II Pilot Study of Short Term (12 Week) Combination Chemotherapy (Stanford V) in Unfavorable Hodgkin's Disease [NCT00002715]Phase 250 participants (Anticipated)Interventional1989-04-30Completed
High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases [NCT00716066]Phase 280 participants (Anticipated)Interventional2008-06-30Recruiting
Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study) [NCT03380026]Phase 228 participants (Actual)Interventional2017-12-13Completed
"Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: Stanford V Regimen For Low Risk Patients, EBVP Regimen For High Risk Patients" [NCT00003262]Phase 230 participants (Anticipated)Interventional1997-05-31Active, not recruiting
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation [NCT02790515]Phase 252 participants (Anticipated)Interventional2016-07-14Recruiting
A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease [NCT00003389]Phase 3854 participants (Actual)Interventional1999-06-17Completed
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.)
Evaluation of Pretargeted Anti-CD20 Radioimmunotherapy Combined With BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk B-Cell Malignancies [NCT02483000]Phase 13 participants (Actual)Interventional2017-02-01Terminated(stopped due to Closed early due to lack of funding)
Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma [NCT03019640]Phase 222 participants (Actual)Interventional2017-10-10Completed
Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial] [NCT00379041]Phase 31,158 participants (Anticipated)Interventional1993-09-01Active, not recruiting
A Phase 1/2 Trial of Carfilzomib and Melphalan and Conditioning for Autologous Stem Cell Transplantation for Multiple Myeloma (CARAMEL) [NCT01842308]Phase 1/Phase 250 participants (Actual)Interventional2013-06-04Completed
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
A Phase I/II Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk Lymphoid Malignancies [NCT01921387]Phase 1/Phase 220 participants (Actual)Interventional2013-10-09Completed
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
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
Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma [NCT01857934]Phase 2153 participants (Actual)Interventional2013-07-05Active, not recruiting
Study to Determine the Aetiology of Chlormethine Gel Induced-skin Drug Reaction in Early Stage Mycosis Fungoides Cutaneous T Cell Lymphoma (MF-CTCL) [NCT04218825]Phase 22 participants (Actual)Interventional2022-03-29Terminated(stopped due to After an extensive assessment of the study feasibility, it was decided to discontinue the clinical trial due to poor recruitment.)
Pilot Study of JAK Inhibitor Therapy Followed by Reduced Intensity Haploidentical Transplantation for Patients With Myelofibrosis [NCT04370301]Phase 210 participants (Anticipated)Interventional2021-02-09Recruiting
Combined T Cell Depleted Haploidentical Peripheral Blood Stem Cell and Unrelated Umbilical Cord Blood Transplantation in Patients With Hematologic Malignancies Using a Total Lymphoid Irradiation Based Preparative Regimen [NCT02199041]Phase 224 participants (Actual)Interventional2014-07-11Terminated(stopped due to The study was halted early due to slow accrual.)
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 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
A Feasibility Study of Myeloablative BEAM Allogeneic Transplantation Followed by Oral Ixazomib Maintenance Therapy in Patients With Relapsed High-Risk Multiple Myeloma [NCT02504359]Phase 111 participants (Actual)Interventional2015-07-20Completed
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.)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003389 (3) [back to overview]Incidence of Second Cancers
NCT00003389 (3) [back to overview]Failure-free Survival at 5 Years
NCT00003389 (3) [back to overview]5-year Overall Survival
NCT00005803 (4) [back to overview]Progression Free-survival (PFS)
NCT00005803 (4) [back to overview]Overall Survival (OS)
NCT00005803 (4) [back to overview]Non-Relapse Mortality
NCT00005803 (4) [back to overview]Engraftment of HLA Identical PBSC Allografts
NCT00114101 (4) [back to overview]Time to Progression
NCT00114101 (4) [back to overview]Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
NCT00114101 (4) [back to overview]Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy
NCT00114101 (4) [back to overview]Overall Survival
NCT00168064 (2) [back to overview]Ratio of Response Rates Based on CAILS
NCT00168064 (2) [back to overview]Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), Symptom Distress Scale
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Age
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)
NCT00352027 (76) [back to overview]Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)
NCT00352027 (76) [back to overview]Local and Distant Failure for Children Treated With Tailored-field Radiation
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Gender
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Histology
NCT00352027 (76) [back to overview]Prognostic Factors for Treatment Failure: Stage
NCT00352027 (76) [back to overview]Toxicities With Grade >1
NCT00352027 (76) [back to overview]3-year Event-free Survival (EFS) Probability
NCT00352027 (76) [back to overview]3-year Event-Free Survival Probability
NCT00352027 (76) [back to overview]3-year Local Failure-free Survival Probability
NCT00352027 (76) [back to overview]3-year Overall Survival (OS) Probability
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Disease Failure Rate Within Radiation Fields
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning
NCT00352027 (76) [back to overview]Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems
NCT00352027 (76) [back to overview]Patient Quality of Life (QoL), PedsQL v.3.0: Communication
NCT00439556 (2) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT)
NCT00439556 (2) [back to overview]Disease-free Survival
NCT00566696 (7) [back to overview]Disease-Free Survival (DFS)
NCT00566696 (7) [back to overview]Event-free Survival (EFS)
NCT00566696 (7) [back to overview]Incidence of Regimen-related Mortality
NCT00566696 (7) [back to overview]Overall Survival (OS)
NCT00566696 (7) [back to overview]Incidence of Non-hematologic Regimen-related Toxicities
NCT00566696 (7) [back to overview]To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.
NCT00566696 (7) [back to overview]To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.
NCT00567567 (14) [back to overview]Intraspinal Extension
NCT00567567 (14) [back to overview]Incidence Rate of Local Recurrence
NCT00567567 (14) [back to overview]Event-free Survival Rate
NCT00567567 (14) [back to overview]EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).
NCT00567567 (14) [back to overview]Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
NCT00567567 (14) [back to overview]Duration of Greater Than or Equal to Grade 3 Neutropenia
NCT00567567 (14) [back to overview]Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
NCT00567567 (14) [back to overview]Type of Surgical or Radiotherapy Complication
NCT00567567 (14) [back to overview]Topotecan Systemic Clearance
NCT00567567 (14) [back to overview]Surgical Response
NCT00567567 (14) [back to overview]Response After Induction Therapy
NCT00567567 (14) [back to overview]Proportion of Patients With a Polymorphism
NCT00567567 (14) [back to overview]Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
NCT00567567 (14) [back to overview]OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology
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
NCT00602641 (4) [back to overview]Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12
NCT00602641 (4) [back to overview]Overall Survival
NCT00602641 (4) [back to overview]Progression-Free Survival (PFS)
NCT00602641 (4) [back to overview]Very Good Partial Response (VGPR) Rate
NCT00793572 (6) [back to overview]Number of Patients Surviving Overall
NCT00793572 (6) [back to overview]Number of Patients Surviving Progression-free
NCT00793572 (6) [back to overview]Number of Patients With Chronic GVHD
NCT00793572 (6) [back to overview]Number of Patients With Grade II-IV Acute GVHD
NCT00793572 (6) [back to overview]Number of Patients With Toxicities Related to Bortezomib Maintenance Therapy
NCT00793572 (6) [back to overview]Number of Patients With Non-relapse Mortality
NCT00899847 (8) [back to overview]Overall Response Rate (ORR)
NCT00899847 (8) [back to overview]Event-free Survival (EFS)
NCT00899847 (8) [back to overview]Complete Response Rate (CRR)
NCT00899847 (8) [back to overview]Incidence of Graft Versus Host Disease (GvHD)
NCT00899847 (8) [back to overview]Median Time to Engraftment After Allo-PBSC Transplant
NCT00899847 (8) [back to overview]Median Time to Engraftment After Auto-PBSC Transplant
NCT00899847 (8) [back to overview]Partial Response Rate (PRR)
NCT00899847 (8) [back to overview]Overall Survival (OS)
NCT00992446 (4) [back to overview]Overall Survival
NCT00992446 (4) [back to overview]Event-free Survival
NCT00992446 (4) [back to overview]Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant
NCT00992446 (4) [back to overview]Median Time to Disease Progression
NCT01008462 (7) [back to overview]Number of Patients With Relapsed/Progressive 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 With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
NCT01008462 (7) [back to overview]Number of Patients Who Had Infections
NCT01008462 (7) [back to overview]Non-relapse Mortality (NRM)
NCT01008462 (7) [back to overview]Overall Survival
NCT01035463 (3) [back to overview]Maximum Tolerated Dose of Lenalidomide (Phase I)
NCT01035463 (3) [back to overview]Event-free Survival
NCT01035463 (3) [back to overview]Overall Survival
NCT01175356 (3) [back to overview]Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
NCT01175356 (3) [back to overview]Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
NCT01175356 (3) [back to overview]Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
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.
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)
NCT01798004 (1) [back to overview]The Tolerability of BuMel Regimen
NCT01807611 (6) [back to overview]Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD)
NCT01807611 (6) [back to overview]Event-free Survival
NCT01807611 (6) [back to overview]Overall Survival
NCT01807611 (6) [back to overview]Number of Transplant Recipients With Transplant-related Mortality (TRM)
NCT01807611 (6) [back to overview]Number of Transplant Recipients With Successful Engraftment
NCT01807611 (6) [back to overview]Number of Transplant Recipients With Malignant Relapse
NCT01824693 (4) [back to overview]Percentage of Participants Who Experience Primary Graft Failure Event Between Arms
NCT01824693 (4) [back to overview]Percent Probability of Event-free Survival (EFS)
NCT01824693 (4) [back to overview]Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100
NCT01824693 (4) [back to overview]Percent Probability of 18 Months-relapse Event Between Arms
NCT01842308 (5) [back to overview]Progression Free Percentage at 1 and 2 Years Post Registration
NCT01842308 (5) [back to overview]Percentage of Patients With Complete Responses, Defined as a Complete Response Noted as the Objective Status on Two Consecutive Evaluations (Phase II)
NCT01842308 (5) [back to overview]Complete Response Rate at Day 100
NCT01842308 (5) [back to overview]Adverse Event Rate, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT01842308 (5) [back to overview]Determine Maximum Tolerated Dose by the Number of Patients With a DLT Per Dose Level
NCT01857934 (6) [back to overview]Dose Limiting Toxicity (DLT)
NCT01857934 (6) [back to overview]Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation
NCT01857934 (6) [back to overview]Event-free Survival (EFS)
NCT01857934 (6) [back to overview]Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy
NCT01857934 (6) [back to overview]Local Failure Rate and Pattern of Failure
NCT01857934 (6) [back to overview]Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]
NCT01921387 (4) [back to overview]The Lowest Antibody (Yttrium 90-BC8-DOTA) Dose (mg/kg) That is Consistent With a Favorable Biodistribution Rate >= 80% in Lymphoma Patients
NCT01921387 (4) [back to overview]Progression-free Survival Following Autologous Stem Cell Transplant (ASCT)
NCT01921387 (4) [back to overview]Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA
NCT01921387 (4) [back to overview]Estimated Dose to Tumor Sites Based on the Tumor to Normal Organ Ratios Derived From Dosimetry Estimates Coupled With the Absorbed Dose to Normal Organs Based on the Administered Activity of Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8
NCT02097134 (4) [back to overview]Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy
NCT02097134 (4) [back to overview]Rate of Metastases of Retinoblastoma
NCT02097134 (4) [back to overview]Number of Patients Experiencing Feasibility Failure
NCT02097134 (4) [back to overview]Probability of Ocular Salvage
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Mortality (TRM)
NCT02199041 (9) [back to overview]Number of Participants With Malignant Relapse
NCT02199041 (9) [back to overview]Number of Participants With Event-free Survival (EFS)
NCT02199041 (9) [back to overview]Number of Participants With Neutrophil Engraftment
NCT02199041 (9) [back to overview]Number of Participants With Overall Survival (OS)
NCT02199041 (9) [back to overview]Number of Participants With Secondary Graft Failure
NCT02199041 (9) [back to overview]Number of Participants With Transplant-related Morbidity
NCT02199041 (9) [back to overview]Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02199041 (9) [back to overview]Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT
NCT02259348 (9) [back to overview]Incidence and Severity of Chronic GvHD
NCT02259348 (9) [back to overview]Incidence of Malignant Relapse
NCT02259348 (9) [back to overview]Event-free Survival (EFS)
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
NCT02296164 (1) [back to overview]Treatment Responders Using Body Surface Area (BSA) at 12 Months
NCT02483000 (3) [back to overview]Overall Survival
NCT02483000 (3) [back to overview]Dosimetry of Yttrium Y 90 DOTA-biotin
NCT02483000 (3) [back to overview]Incidence of Toxicity, Defined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
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]Demonstrate the Feasibility of Collecting Patient-reported Outcomes for Trial Participants
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]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
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]Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
NCT02756572 (19) [back to overview]Overall Survival (OS) Among Patients Who Did Not Receive Early Transplant
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]Factors That Distinguish Patients Who Received Early Transplant From Those Who Did Not - AGE
NCT02756572 (19) [back to overview]Event-free Survival (EFS) 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]Acute Graft Versus Host Disease 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]Event-free Survival (EFS) Among Patients Who Received Early Transplant
NCT02756572 (19) [back to overview]Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28
NCT02797470 (1) [back to overview]Percentage of Participants Who Achieve a Timely Engraftment
NCT03019640 (2) [back to overview]Treatment-related Mortality Within 30 Days (TRM30)
NCT03019640 (2) [back to overview]Number of Participants Who Survived
NCT03096782 (3) [back to overview]Disease-free Survival
NCT03096782 (3) [back to overview]Overall Survival
NCT03096782 (3) [back to overview]Time to Engraftment
NCT03380026 (3) [back to overview]Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
NCT03380026 (3) [back to overview]Severity of Dermatitis
NCT03380026 (3) [back to overview]Efficacy of Valchlor vs Valchlor Plus Triamcinolone
NCT03417141 (4) [back to overview]Change in Dermatology Quality of Life Index (DQLI)
NCT03417141 (4) [back to overview]Change in Lichen Planopilaris Activity Index (LLPAI)
NCT03417141 (4) [back to overview]Change in Mean Follicular Density
NCT03417141 (4) [back to overview]Change in Follicular Units
NCT03786783 (5) [back to overview]"Percentage of Participants Who Are Feasibility Failure"
NCT03786783 (5) [back to overview]Event-free Survival
NCT03786783 (5) [back to overview]Overall Survival
NCT03786783 (5) [back to overview]Percentage of Participants With Unacceptable Toxicity
NCT03786783 (5) [back to overview]Response Rate
NCT04205240 (2) [back to overview]Number of Patients With a Partial Response
NCT04205240 (2) [back to overview]Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD)
NCT04339101 (3) [back to overview]Progression Free Survival (PFS)
NCT04339101 (3) [back to overview]Cumulative Incidence of Grade II-IV Acute GVHD
NCT04339101 (3) [back to overview]Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year

Incidence of Second Cancers

Number of patients who developed second primary cancers (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

Interventionparticipants (Number)
Arm A (ABVD)15
Arm B (Stanford V)19

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Failure-free Survival at 5 Years

"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission." (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5

InterventionProportion of patients (Number)
Arm A (ABVD)0.74
Arm B (Stanford V)0.71

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5-year Overall Survival

Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years. (NCT00003389)
Timeframe: Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years

InterventionProportion of patients (Number)
Arm A (ABVD)0.88
Arm B (Stanford V)0.88

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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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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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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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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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Time to Progression

"Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.~Progression was defined per the International Myeloma Working Group definition as one more of the following:~25% increase in serum M-component (absolute increase >= 0.5g/dl)~25% increase in urine M-component (absolute increase >= 200mg/24hour~25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)~25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)~Definite development of new bone lesion or soft tissue plasmacytomas~Development of hypercalcemia" (NCT00114101)
Timeframe: Duration of study (up to 10years)

Interventionmonths (Median)
Lenalidomide Maintenance39
Placebo Maintenance21

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Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100

"Response was defined according to International Myeloma Working Group criteria (2006)~Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)~Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels~Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour~Progressive Disease: Defined in primary outcome measure~Stable Disease: Not meeting any of the criteria above" (NCT00114101)
Timeframe: Day 100

,
Interventionparticipants (Number)
Complete responsePartial responseMarginal responseStable diseaseProgressive diseaseUnknown
Lenalidomide Maintenance67115113800
Placebo Maintenance7910953231

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Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy

Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome. (NCT00114101)
Timeframe: Duration of study (up to 10 years)

Interventionparticipants (Number)
Lenalidomide Maintenance92
Placebo Maintenance133

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Overall Survival

Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method. (NCT00114101)
Timeframe: Duration of study (up to 10 years)

Interventionmonths (Median)
Lenalidomide MaintenanceNA
Placebo MaintenanceNA

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Ratio of Response Rates Based on CAILS

The ratio of the response rate of the patients treated with the PG formulation to the response rate of the patients treated with the AP formulation. Skin response determined by at least a 50% reduction from baseline in the Composite Assessment of Index Lesion Severity (CAILS) following up to 12 months of treatment (NCT00168064)
Timeframe: Assessment made at Day 1 and every subsequent visit during treatment

Interventionpercentage of participants (Number)
PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel76
AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%62

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Percent of Participants Achieving at Least 50% Improvement of Severity Weighted Assessment Tool (SWAT)

Assessment of lesion distribution and severity. A responder analysis was performed on whether subject achieved at least 50% improvement on scale. This had to be confirmed on at least one visit at least 4 weeks apart. (NCT00168064)
Timeframe: Baseline to end of therapy

InterventionPercent of participants (Number)
PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel61
AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor60

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Patient Quality of Life (QoL), PedsQL v.3.0: Nausea

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 862.7
Week 1260.1
After Radiation76.7
Off-therapy81.6

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Patient Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 863.9
Week 1271.5
After Radiation79.9
Off-therapy88.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1281.3
After Radiation81.4
Off-therapy84.7

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Patient Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.8
Week 1270.9
After Radiation68.1
Off-therapy80.1

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Patient Quality of Life (QoL), PedsQL v.3.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.1
Week 1274.2
After Radiation81.7
Off-therapy83.5

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Patient Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 889.2
Week 1282
After Radiation89.4
Off-therapy87.3

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Patient Quality of Life (QoL), PedsQL v.3.0: Worry

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.2
Week 1272.2
After Radiation74.5
Off-therapy76.0

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Patient Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy72.6
Week 875.3
Week 1275.7
After Radiation84.5
Off-therapy81.6

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Patient Quality of Life (QoL), PedsQl v.4.0: Physical Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy83.2
Week 868.4
Week 1269.1
After Radiation80.8
Off-therapy85.2

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Procedural Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.2
Parent and Patient Scores at Week 12-9.3
Parent and Patient Scores at After Radiation-2.2
Parent and Patient Scores at Off-therapy-8.7

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Patient Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.3
Week 877.6
Week 1278.6
After Radiation84.3
Off-therapy84.3

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Patient Quality of Life (QoL), PedsQL v.4.0: School Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy73.1
Week 869.5
Week 1272.6
After Radiation78.4
Off-therapy81.3

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Patient Quality of Life (QoL), PedsQL v.4.0: Total Score

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy80.9
Week 874.4
Week 1275.3
After Radiation83.1
Off-therapy84.5

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Patient Quality of Life (QoL), PedsQL v.4.0:Social Functioning

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy90.9
Week 888.6
Week 1288.0
After Radiation90.1
Off-therapy91.1

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Patient Quality of Life (QoL), Symptom Distress Scale

"The patient's degree of discomfort from specific treatment-related symptoms across multiple time points.~Instrument interpretation: SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy17.3
Week 819.6
Week 1218.1
After Radiation15.1
Off-therapy14.3

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Prognostic Factors for Treatment Failure: Age

Age was examined for the association with event-free survival (EFS) which was defined as the interval between date on study and date of relapse/disease progression, second malignant tumor, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. (NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stanford V Chemotherapy11

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Echocardiogram)

Echocardiograms will be carried out on the patient at 1, 2, 5, and 10 years after therapy. Outcomes will be categorized. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy680
Year 10 Off Therapy151
Year 2 Off Therapy571
Year 5 Off Therapy362

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Electrocardiogram)

Electrocardiograms (EKGs) will be conducted on the patient at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, determined by the test outcome. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy515
Year 10 Off Therapy106
Year 2 Off Therapy448
Year 5 Off Therapy244

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: (Pulmonary Function)

Patient pulmonary function will undergo assessment at 1, 2, 5, and 10 years after therapy. Results will be categorized as either normal or abnormal, depending on the test results. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalAbnormal
Year 1 Off Therapy4620
Year 10 Off Therapy91
Year 2 Off Therapy4120
Year 5 Off Therapy2511

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Describe Toxicities, Particularly the Frequency and Severity of Late Effects of Therapy: Thyroid (TSH)

For patients that received cervical radiation, TSH laboratory testing will be conducted at 1, 2, 5 and 10 years. TSH results will be categorized as Normal, Hypothyroid, Hyperthyroid, or Thyroid Nodule, depending on the test's findings. (NCT00352027)
Timeframe: 1, 2, 5, and 10 years post therapy

,,,
InterventionParticipants (Count of Participants)
NormalHypothyroidHyperthyroidThyroid Nodule
Year 1 Off Therapy60820
Year 10 Off Therapy20300
Year 2 Off Therapy541110
Year 5 Off Therapy37810

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Local and Distant Failure for Children Treated With Tailored-field Radiation

The cumulative incidence of local and distant failure will be estimated. Effect of competing risks will be taken into account. Local failure is defined as in-field, and distant failure is defined as out-of-field. (NCT00352027)
Timeframe: from first enrollment date up to 3 years follow-up

Interventionprobability that the event occurs (Number)
Cumulative incidence of distant failure at 3 yearsCumulative incidence of local failure at 3 years
Stanford V Chemotherapy0.03750.1127

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Prognostic Factors for Treatment Failure: Gender

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
MaleFemale
Stanford V Chemotherapy56

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Prognostic Factors for Treatment Failure: Histology

Event-free survival (EFS) was calculated for the 80 eligible patients. EFS was defined as the interval between on study to relapse, second malignant tumor, or last contact (all alive) whichever came first. For those who had multiple relapses, the first one was counted. Given only 11 events, we examined individually age, gender, histology and stage for its association with EFS using Cox model. P values from Score test were computed for the statistical significance. (NCT00352027)
Timeframe: 3 years follow-up

Interventionevents (Number)
Classical, Nodular SclerosingOther
Stanford V Chemotherapy101

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Prognostic Factors for Treatment Failure: Stage

Ann Arbor staging classification was used to stage all patients. Stage was examined (I/II versus III) for the association with event-free survival (EFS), defined as the interval between date on study and of relapse/disease progression, second malignancy, death, or last contact, whichever came first. Given only 11 events, the investigators used univariate Cox model with Score test to compute the p value for the statistical significance. Stage NCT00352027)
Timeframe: 5.5 (years) median follow-up with minimum 0.3 to maximum 9.4 years follow-up

Interventionevents (Number)
Stage Stage ≥III
Stanford V Chemotherapy83

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Toxicities With Grade >1

Comparison of the toxicities of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation (current HOD05 protocol) to those patients on HOD99 (NCT00145600). Grading of toxicities for HOD05 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT00352027)
Timeframe: 3 years

,,,,,,,
Interventionadverse events (Number)
Alanine transaminase (ALT)Aspartate transaminase (AST)Allergic reaction/hypersensitivityConstipationFebrile neutropeniaFever (in the absence of neutropenia)GlucoseGGT (gamma-Glutamyltranspeptidase)HemoglobinHypoxiaIleus, GI (functional obstruction of bowel)Infection with Grade 3 or 4 neutrophilsInfection - OtherInfection with normal ANC or Grade 1-2 neutrophilsInfection with unknown ANCInsomniaLeukocytes (total WBC)LymphopeniaMucositis/stomatitis (functional/symptomatic)NauseaNeuropathy: motorNeuropathy: sensoryNeutrophils/granulocytes (ANC/AGC)PainPhosphatePlateletsPotassiumSodiumSyndromes - OtherThrombosis/embolism (vascular access-related)Thrombosis/thrombus/embolismVomiting
HOD05 - Grade 200000000000000000000000000000000
HOD05 - Grade 3114072012611213014122010124510211202
HOD05 - Grade 40000100060000000157000032000000010
HOD05 - Grade 500000000000000000000000000000000
HOD99 - Grade 200000000000000000000000000000001
HOD99 - Grade 3000150002002011019012119103000004
HOD99 - Grade 4000020100000000050000030100000000
HOD99 - Grade 500000000000000000000000000000000

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3-year Event-free Survival (EFS) Probability

Comparison of thee-year EFS probability along with the whole EFS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.844

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3-year Event-Free Survival Probability

The survival probability for the time interval from treatment start to the time of the first failure (disease recurrence, second malignancy or death) within a 3-year time frame. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
Stanford V Chemotherapy0.887

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3-year Local Failure-free Survival Probability

Comparison of the 3-year local failure-free survival probability along with the whole local failure-free survival distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3 years

Interventionprobability (Number)
HOD05 Participants0.887
HOD99 Participants0.932

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3-year Overall Survival (OS) Probability

Comparison of the 3-year OS probability along with the whole OS distributions of intermediate risk patients treated with Stanford V chemotherapy low dose tailored-field radiation to those patients on HOD99. (NCT00352027)
Timeframe: 3-years

Interventionprobability (Number)
HOD05 Participants1.00
HOD99 Participants0.978

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Cognitive Problems

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Communication

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.35

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Nausea

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.31

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Pain and Hurt

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-2.52

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Perceived Physical Appearance

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.20

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Procedural Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.87

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Total Score

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.41

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Treatment Anxiety

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.96

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.3.0: Worry

"Relationship between quality of life and symptom distress across multiple time points [completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.3.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.06

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Emotional Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.56

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Physical Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.9

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Psychosocial Health

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.92

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: School Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.21

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Social Functioning

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-0.79

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Association Between Patient-Reported QoL and Symptom Distress, PedsQL v.4.0: Total Score

"Relationship between quality of life and symptom distress instruments aggregated across multiple time points [At diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy]. Generalized estimating equations (GEE) were used to examine the association between symptoms distress and QoL scores.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. SDS, higher scores indicate higher overall symptom distress with a range of 10-50." (NCT00352027)
Timeframe: 6 months after the completion of therapy

Interventionbeta coefficient (Number)
QoL Participants-1.46

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Cognitive Problems

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.0
Parent and Patient Scores at Week 120.14
Parent and Patient Scores at After Radiation-8.0
Parent and Patient Scores at Off-therapy-4.0

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Communication

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.3
Parent and Patient Scores at Week 12-3.6
Parent and Patient Scores at After Radiation-7.4
Parent and Patient Scores at Off-therapy-6.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Nausea

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.2
Parent and Patient Scores at Week 12-3.4
Parent and Patient Scores at After Radiation-3.0
Parent and Patient Scores at Off-therapy-1.1

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Pain and Hurt

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.0
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-5.4

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Perceived Physical Appearance

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-2.5
Parent and Patient Scores at Week 12-9.5
Parent and Patient Scores at After Radiation-5.9
Parent and Patient Scores at Off-therapy-9.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-1.5
Parent and Patient Scores at Week 12-5.2
Parent and Patient Scores at After Radiation-4.5
Parent and Patient Scores at Off-therapy-5

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Treatment Anxiety

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-6.1
Parent and Patient Scores at Week 12-8.8
Parent and Patient Scores at After Radiation-7.9
Parent and Patient Scores at Off-therapy-6.6

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.3.0: Worry

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Week 8-0.7
Parent and Patient Scores at Week 12-3.9
Parent and Patient Scores at After Radiation-2.7
Parent and Patient Scores at Off-therapy-0.5

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Emotional Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-4.9
Parent and Patient Scores at Week 8-9.4
Parent and Patient Scores at Week 12-8.0
Parent and Patient Scores at After Radiation-10.8
Parent and Patient Scores at Off-therapy-1.7

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Physical Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-2.3
Parent and Patient Scores at Week 12-1.9
Parent and Patient Scores at After Radiation-5.4
Parent and Patient Scores at Off-therapy-2

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Psychosocial Health

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.8
Parent and Patient Scores at Week 8-6.4
Parent and Patient Scores at Week 12-6.3
Parent and Patient Scores at After Radiation-5.6
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: School Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy1.3
Parent and Patient Scores at Week 8-5.3
Parent and Patient Scores at Week 12-4.1
Parent and Patient Scores at After Radiation-3.4
Parent and Patient Scores at Off-therapy-4.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Social Functioning

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-5.3
Parent and Patient Scores at Week 8-5.7
Parent and Patient Scores at Week 12-7.4
Parent and Patient Scores at After Radiation-5.0
Parent and Patient Scores at Off-therapy-3.3

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Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points, PedsQL v.4.0: Total Score

"Assess and compare the patient reported and parent proxy quality of life across multiple time points. Reported mean differences were calculated as parent score minus patient score.~Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. Reported mean differences were calculated as: parent score - patient score." (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Parent and Patient Scores at Pre-therapy-2.9
Parent and Patient Scores at Week 8-4.8
Parent and Patient Scores at Week 12-4.8
Parent and Patient Scores at After Radiation-5
Parent and Patient Scores at Off-therapy-2.9

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Disease Failure Rate Within Radiation Fields

Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). (NCT00352027)
Timeframe: 3 years

Interventionproportion of participants (Number)
Stanford V Chemotherapy0.1125

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 877.6
Week 1279.5
After Radiation78.6
Off-therapy79.9

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Communication

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.2
Week 1280.4
After Radiation80.3
Off-therapy84.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Nausea

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1257.4
After Radiation72.2
Off-therapy83.2

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Pain and Hurt

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 861.2
Week 1261.8
After Radiation73.1
Off-therapy82.7

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Perceived Physical Appearance

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 874.9
Week 1272.2
After Radiation73.7
Off-therapy76.3

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Procedural Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870.0
Week 1260.0
After Radiation63.1
Off-therapy73.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 871.7
Week 1269.3
After Radiation74.5
Off-therapy80.0

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Treatment Anxiety

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 881.9
Week 1272.6
After Radiation78.5
Off-therapy81.8

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Parent Proxy Quality of Life (QoL), PedsQL v.3.0: Worry

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100. (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 870
Week 1269.2
After Radiation71.9
Off-therapy78.7

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Emotional Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy67.7
Week 865.4
Week 1268.1
After Radiation73.0
Off-therapy82.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Physical Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy79.8
Week 865.3
Week 1267.3
After Radiation73.6
Off-therapy84.6

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Psychosocial Health

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy76.2
Week 871.0
Week 1274.1
After Radiation79.0
Off-therapy88.0

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: School Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy74.4
Week 862.8
Week 1270.8
After Radiation75.6
Off-therapy78.9

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Social Functioning

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy86.1
Week 883.0
Week 1280.7
After Radiation85.1
Off-therapy89.1

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Parent Proxy Quality of Life (QoL), PedsQL v.4.0: Total Score

Parent's assessment of child's functioning over multiple time points. Instrument interpretation: PedsQL v.4.0, higher scores indicate better HRQOL with a range of 0-100. (NCT00352027)
Timeframe: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Pre-therapy77.6
Week 869.1
Week 1272.3
After Radiation77.8
Off-therapy83.5

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Patient Quality of Life (QoL), PedsQL v.3.0: Cognitive Problems

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 879.1
Week 1278.2
After Radiation87.0
Off-therapy82.0

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Patient Quality of Life (QoL), PedsQL v.3.0: Communication

"Patient QOL will be measured at multiple time points to assess the patient's functioning.~Instrument interpretation: PedsQL v.3.0, higher scores indicate lower problems with a range of 0-100." (NCT00352027)
Timeframe: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), completion of radiation (T4), and 3-6 months (T5) after the completion of therapy

Interventionunits on a scale (Mean)
Week 880.7
Week 1283.0
After Radiation87.2
Off-therapy89.0

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Number of Participants With Dose Limiting Toxicity (DLT)

To determine the maximum tolerated dose(MTD) of velcade and dose limiting toxicity(DLT). A dose limiting toxicity (DLT) was defined as a grade 3-4 neurological toxicity, graft failure, or death due to GvHD. The Commom Terminlogy Criteria for Adverse Events v3.0 was used. (NCT00439556)
Timeframe: From start of treatment to 90 days after the start of treatment

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, Transplant, Filgrastim, Tacrolimus)0
Velcade Dose Level 20
Velcade Dose Level 30

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Disease-free Survival

To determine DFS at 1 year post transplant. (NCT00439556)
Timeframe: At 1 year

InterventionParticipants (Count of Participants)
Velcade Dose Level 116
Velcade Dose Level 20
Velcade Dose Level 30

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Disease-Free Survival (DFS)

Estimate the one-year disease-free survival (DFS) for research participants who receive this study treatment. DFS is defined as time from transplantation to the occurrence of relapse or death due to relapse. Patients who are alive at the time of analysis or die due to other causes will be censored at the time of their events. The estimated percentage of participants with DFS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: One year post-transplant

InterventionPercentage of participants (Number)
High-Risk Hematologic Malignancies70.1

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Event-free Survival (EFS)

To determine if one year event-free survival can be improved in pediatric patients undergoing a haploidentical transplant by using a reduced intensity conditioning regimen and a targeted dose T cell depleted donor product. EFS is defined as time from transplantation to the occurrence of relapse or death due to any cause. Patients who are alive at the time of analysis will be censored. The estimated percentage of participants with EFS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: one year post-transplant

InterventionPercentage of participants (Number)
High-Risk Hematologic Malignancies54.8

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Overall Survival (OS)

Estimate the one-year overall survival (OS) for research participants who receive this study treatment. OS is defined as time from transplantation to death due to any cause. Patient who are alive at the time of analysis will be censored. The estimated percentage of participants with OS at one-year post-transplantation is reported using Kaplan-Meier analysis. (NCT00566696)
Timeframe: one year post-transplant

InterventionPercentage of participants (Number)
High-Risk Hematologic Malignancies71.0

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To Estimate the Cumulative Incidence of Relapse for Research Participants Who Receive This Study Treatment.

The Cumulative Incidence of Relapse will be reported as the proportion of number of relapses since transplant to the total number of patients at risk at five years post-transplant. (NCT00566696)
Timeframe: five years post-transplant

InterventionPercentage of participants (Number)
The Cumulative Incidence of Relapse at five year pEstimate±SE
High-Risk Hematologic Malignancies30.08.6

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To Estimate the Rate of Overall Grade III-IV Acute GVHD, and the Rate and Severity of Chronic GVHD in Research Participants.

The rate of Overall Grade III-IV Acute AVHD will be report as the proportion of patients who have Grade III-IV Acute GVHD to the total patients with transplant. The rate of Chronic GVHD will be report as the proportion of patients who have Chronic GVHD to the total patients with transplant. The Severity of Chronic GVHD will be reported using CTCAE grading system, as a number. (NCT00566696)
Timeframe: five years post-transplant

InterventionPercentage of participants (Number)
Rate of Overall Grade III-IV Acute AVHDRate of limited grade Chronic GVHD
High-Risk Hematologic Malignancies22.589.68

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Intraspinal Extension

Percentage of patients with primary tumors with intraspinal extension. (NCT00567567)
Timeframe: Up to 5 years

InterventionPercentage of patients (Number)
Single HST (CEM)8.25
Tandem HST (CEM), Randomly Assigned9.66
Not Assigned7.78

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Incidence Rate of Local Recurrence

Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation. (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage 3-year cumulative incidence (Number)
Single HST (CEM)15.7

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Event-free Survival Rate

Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM) (NCT00567567)
Timeframe: Three years, from time of randomization

Interventionpercent probability (Number)
Single HST (CEM)48.8
Tandem HST (CEM), Randomly Assigned61.8

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EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).

Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years

Interventionpercent probability (Number)
Single HST (CEM)73.1

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Duration of Greater Than or Equal to Grade 3 Thrombocytopenia

A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days

InterventionDays (Median)
Single HST (CEM)4
Tandem HST (CEM), Randomly Assigned4
Not Assigned4

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Duration of Greater Than or Equal to Grade 3 Neutropenia

A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism. (NCT00567567)
Timeframe: Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days

InterventionDays (Median)
Single HST (CEM)7
Tandem HST (CEM), Randomly Assigned7
Not Assigned7

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Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells

A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed. (NCT00567567)
Timeframe: Up to 6 months after completion of assigned myeloablation therapy

,
Interventioncells/mm^3 (Median)
CD3CD4CD8
Single HST (CEM)20073104
Tandem HST (CEM), Randomly Assigned255.581151

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Type of Surgical or Radiotherapy Complication

The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea. (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage of patients (Number)
Single HST (CEM)13.11
Tandem HST (CEM), Randomly Assigned12.50
Not Assigned11.85

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Topotecan Systemic Clearance

Median topotecan systemic clearance for courses 1 and 2. (NCT00567567)
Timeframe: Day 1 of courses 1-2

InterventionL/h/m2 (Median)
Single HST (CEM)28.1
Tandem HST (CEM), Randomly Assigned28.1
Not Assigned28.5

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Surgical Response

Percentage of patients who achieved a surgical complete resection (NCT00567567)
Timeframe: Up to 3 years

InterventionPercentage of patients (Number)
Single HST (CEM)83.98
Tandem HST (CEM), Randomly Assigned84.09
Not Assigned58.89

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Response After Induction Therapy

Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion (primary or metastases) with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT00567567)
Timeframe: Study enrollment to the end of induction therapy

InterventionProportion participants that responded (Number)
Single HST (CEM)0.54
Tandem HST (CEM), Randomly Assigned0.48
Not Assigned0.35

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Proportion of Patients With a Polymorphism

A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population. (NCT00567567)
Timeframe: Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days

InterventionProportion of patients (Number)
Single HST (CEM)0.96
Tandem HST (CEM), Randomly Assigned0.96
Not Assigned0.97

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Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies

Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532 (NCT00567567)
Timeframe: Day 1 of each course

InterventionMicromolar (Median)
Single HST (CEM)1.00
Tandem HST (CEM), Randomly Assigned1.36
Not Assigned1.26

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OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology

Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated. (NCT00567567)
Timeframe: Up to 3 years

Interventionpercent probability (Number)
Single HST (CEM)81.0

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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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Change in Functional Assessment of Cancer Therapy-Neurotoxicity Trial Outcome Index (FACT-Ntx TOI) Score From Baseline to Cycle 12

A combined scale was used to assess the quality of life (QOL) comprising of the well established and validated functional well-being (FWB) and physical well-being (PWB) components of FACT-G version 4 (14 questions), which will address the physical and functional well-being of multiple myeloma patients plus the FACT-neurotoxicity (NTX, 11 questions), which will evaluate symptoms of neurotoxicity. This pooled scale is referred to as the FACT Ntx TOI. The FACT-Ntx TOI has 25 items and the score ranges from 0 (worst possible outcome) to 100 (best possible outcome). (NCT00602641)
Timeframe: Administered at registration, the beginning of cycle 7 d1, the end of cycle 12 d28, then at the end of cycle 18, 24, and 38 d28. For patients who discontinue treatment early, assessed at time of discontinuation and at the next quarterly follow-up visit.

Interventionunits on a scale (Mean)
Arm I (MPT-T)-2.8
Arm II (mPR-R)3.3

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Overall Survival

Overall survival was defined as time from randomization to death from any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Interventionmonths (Median)
Arm I (MPT-T)52.6
Arm II (mPR-R)47.7

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Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the earlier of progression or death of any cause. (NCT00602641)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 10 years from the date of randomization.

Interventionmonths (Median)
Arm I (MPT-T)21.0
Arm II (mPR-R)18.7

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Very Good Partial Response (VGPR) Rate

Response evaluation was based on the International Myeloma Working Group (IMWG) response criteria. VGPR rate was defined as patients achieving at least VGPR which include patients who achieving complete response (CR) and VGPR. CR refers to patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow. VGPR refers to patients who meet the following criteria: Serum and urine M-component detectable by immunofixation but not on electrophoresis; Or 90% or greater reduction in serum M-component plus urine M-component <100 mg per 24 hours; If the serum and urine M protein are unmeasurable and the immunoglobulin free light chain parameter is being used to measure response, a ≥ 90% decrease in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M protein criteria. (NCT00602641)
Timeframe: Assessed every cycle (1 cycle=28 days) for the first 12 cycles, and then every 2 cycles while on treatment. Post treatment assessed every 3 months < 2 years from study entry, every 6 months if 2-5 years, every 12 months if 6-10 years from study entry.

Interventionproportion of participants (Number)
Arm I (MPT-T)0.247
Arm II (mPR-R)0.316

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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 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 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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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 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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Overall Response Rate (ORR)

Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR) (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Peripheral Blood Stem Cell Transplant7

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Event-free Survival (EFS)

To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled

Interventionpercentage of participants (Number)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant44

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Complete Response Rate (CRR)

"Complete response rate (CRR) was assessed as all of:~Negative immunoflixation on the serum and urine~Disappearance of any soft tissue plasmacytomas~< 5% plasma cells in bone marrow" (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant3

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Incidence of Graft Versus Host Disease (GvHD)

To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting (NCT00899847)
Timeframe: 2 years after the last participant is enrolled.

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant1

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Median Time to Engraftment After Allo-PBSC Transplant

"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia" (NCT00899847)
Timeframe: 1 month

InterventionDays (Median)
Neutrophil EngraftmentPlatelet Engraftment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant2410

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Median Time to Engraftment After Auto-PBSC Transplant

"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia" (NCT00899847)
Timeframe: 1 month

InterventionDays (Median)
Neutrophil EngraftmentPlatelet Engraftment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant1115

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Partial Response Rate (PRR)

"Partial response rate (PRR) was assessed as~> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr~If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain~If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma." (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Peripheral Blood Stem Cell Transplant4

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Overall Survival (OS)

To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled

Interventionpercentage of participants (Number)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant67

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Overall Survival

Number of patients alive who received maintenance therapy (NCT00992446)
Timeframe: 6.64 Years Post-Transplant

Interventionparticipants (Number)
AliveDead
Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))163

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Event-free Survival

Number of patients alive without disease progression/relapse (NCT00992446)
Timeframe: 6.64 Years Post-Transplant

InterventionParticipants (Count of Participants)
Alive without disease porgressionalive with disease progression
Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))145

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Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant

Number of patients on maintenance therapy post-transplant who experienced grade 3 or higher toxicity per NCI-Common Terminology Criteria for Adverse Events, version 3. The first three months of bortezomib and vorinostat therapy will be used as the time period to evaluate toxicity for stopping rules of the study. Toxicity that meets stopping rules will be determined based on the number of patients that are withdrawn from study for significant toxicity (grade IV, non-hematological, non-metabolic, non-peripheral neuropathy). (NCT00992446)
Timeframe: 3 months after start of maintenance therapy

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))19

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Median Time to Disease Progression

median days from transplant to relapse/progression (NCT00992446)
Timeframe: time post ASCT to progression

Interventionyears (Median)
Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))1.05

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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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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 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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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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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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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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Maximum Tolerated Dose of Lenalidomide (Phase I)

The Maximum Tolerated Dose (MTD) is defined to be the dose cohort below which 3 out of 6 subjects experience dose limiting toxicities during cycle 1. Dose limiting toxicities graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCT01035463)
Timeframe: Cycle 1, 28 days

Interventionmilligrams PO daily (Number)
Treatment (Stem Cell Transplantation)10

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Event-free Survival

The Kaplan-Meier method will be used to estimate the event-free survival distribution. (NCT01035463)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Phase I Participants84
All Phase II Participants87

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Overall Survival

The Kaplan-Meier method will be used to estimate the overall survival distribution. This outcome only reports data as it pertains to overall survival at one year. All-cause mortality includes survival for follow up for all subjects on the study. (NCT01035463)
Timeframe: 1 year

Interventionpercentage of participants (Number)
All Phase I Participants100
All Phase II Participants95

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Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG

Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory. (NCT01175356)
Timeframe: Up to 6 weeks after course 5 of induction

InterventionParticipants (Count of Participants)
Treatment (131I-MIBG, Chemotherapy)3

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Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy

Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%. (NCT01175356)
Timeframe: Up to day -6 of conditioning

InterventionPercentage of participants (Number)
Treatment (131I-MIBG, Chemotherapy)82.2

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Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131

Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%. (NCT01175356)
Timeframe: Up to 6 weeks after course 5 of induction

InterventionPercentage of participants (Number)
Treatment (131I-MIBG, Chemotherapy)86.8

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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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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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The Tolerability of BuMel Regimen

Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy. (NCT01798004)
Timeframe: Up to 28 days post-consolidation therapy, up to 1 year

Interventionparticipants (Number)
All Patients9

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Number of Transplant Recipients With Acute and/or Chronic Graft Versus Host Disease (GVHD)

Acute and chronic graft-vs.-host disease will be evaluated using the standard grading criteria. The estimate will be the number of recipients who experienced GVHD divided by the total number of patients considered in this group. (NCT01807611)
Timeframe: 100 days post-transplant for acute GVHD; one year post-transplant for chronic GVHD .

InterventionParticipants (Count of Participants)
Number of Transplant Recipients With Acute Graft Versus Host Disease (aGVHD)24
Number of Transplant Recipients With Chronic Graft Versus Host Disease (cGVHD)16

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Event-free Survival

The one-year event free survival is defined by the patient who has neither experienced relapse nor death within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year event free survival patients and the total number of patients. (NCT01807611)
Timeframe: One year post-transplantation

InterventionParticipants (Count of Participants)
Experimental: Transplant Recipients49

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Overall Survival

The one-year survival is defined by the patient who has not died within one year after post transplantation. And the rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. (NCT01807611)
Timeframe: one year post-transplantation

InterventionParticipants (Count of Participants)
Experimental: Transplant Recipients59

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Number of Transplant Recipients With Successful Engraftment

Neutrophil engraftment will be determined using the parameters put forth by the Center for International Blood and Marrow Registry. Assessments will be made upon review of daily complete blood count and serial chimerism studies. Successful engraftment for the purposes of this objective will be patients who do not experience graft failure. (NCT01807611)
Timeframe: 42 days post engraftment

InterventionParticipants (Count of Participants)
Experimental: Transplant Recipients70

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Number of Transplant Recipients With Malignant Relapse

Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. (NCT01807611)
Timeframe: One-year post-transplantation

InterventionParticipants (Count of Participants)
Experimental: Transplant Recipients18

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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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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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Progression Free Percentage at 1 and 2 Years Post Registration

"Progression is an Increase of 25% from lowest value in any of the following (A 25% increase refers to M protein, FLC and bone marrow results and does not refer to bone lesions, soft tissue plasmacytoma or hypercalcemia. The lowest value does not need to be a confirmed value. If the lowest serum Mprotein is ≥ 5 g/dL, an increase in serum M-protein of ≥ 1 g/dL is sufficient to define disease progression.), (In the case where a value is felt to be a spurious result per physician discretion (for example, a possible lab error), that value will not be considered when determining the lowest value.): Serum M-protein (absolute increase must be ≥ 0.5 g/dL) and/or Urine M-protein (absolute increase must be ≥ 200 mg/24 hrs) and/or If the only measurable disease is FLC, the difference between involved and uninvolved FLC levels (absolute increase must be>10 mg/dL) and/or If the only measurable disease is BM, bone marrow PC percentage (absolute increase must be ≥ 10%) (Bone marrow criteria for PD" (NCT01842308)
Timeframe: At 1 year and 2 years

Interventionpercentage of patients (Number)
1 year2 years
Dose Level 390.2475.61

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Percentage of Patients With Complete Responses, Defined as a Complete Response Noted as the Objective Status on Two Consecutive Evaluations (Phase II)

The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success percentages will be calculated. (NCT01842308)
Timeframe: Up to 5 years

Interventionpercentage of patients (Number)
Dose Level 321.95

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Complete Response Rate at Day 100

Complete response rate (CRR) is defined as the percentage of complete responses estimated by the total number of patients who achieve a complete response by day 100 post-transplant divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true complete response rate at day 100 will be calculated. (NCT01842308)
Timeframe: At day 100

Interventionpercentage of patients (Number)
Dose Level 317.07

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Adverse Event Rate, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

These results are reported in the adverse events section. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. (NCT01842308)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Phase 1: Dose Level 36
Phase 1: Dose Level 23
Phase 1: Dose Level 13
Phase 1: Dose Level 02
Phase 2: Dose Level 335

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Determine Maximum Tolerated Dose by the Number of Patients With a DLT Per Dose Level

Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity(DLT) in at least one-third of patients. For this study, a DLT is any of the following during the first 2 cycles of treatment; Absolute neutrophil count engraftment* delayed beyond day 21 or Platelet engraftment* delayed beyond day 30, grade 3+ related sensory or motor neuropathy, or grade 4+ related non-neurologic or non-hematologic adverse event(excluding nausea, vomiting, and diarrhea. Reported below are the number of patients who experienced a DLT. (NCT01842308)
Timeframe: Up to day 30

InterventionParticipants (Count of Participants)
Phase 1: Dose Level 31
Phase 1: Dose Level 20
Phase 1: Dose Level 10
Phase 1: Dose Level 00

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Dose Limiting Toxicity (DLT)

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) Toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade 3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding. (NCT01857934)
Timeframe: During MRD treatment cycle (approximately 8-12 months after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)1

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Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation

Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding in any subject receiving the hu14.18K322A with NK cell combination; 4) Failure of recovery of ANC > 500/mm3 by day 35 after PBSC infusion. Number of patients who experience Grade 3 or Grade 4 (per Common Toxicity Criteria v 4.0) veno occlusive disease (VOD). (NCT01857934)
Timeframe: During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)0

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Event-free Survival (EFS)

EFS was estimated as time to relapse, progressive disease, secondary neoplasm, or death from any cause from enrollment. The EFS was estimated by Kaplan-Meier method (NCT01857934)
Timeframe: 3 years, from time of enrollment

Interventionpercent of probability (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)73.7

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Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy

"The study is designed to monitor the feasibility of delivering hu14.18K332A to 6 cycles of Induction chemotherapy. The feasibility of Induction therapy for this study will be to target no worse than 75%. A patient was considered as a failure for the 6 cycles of Induction therapy if the patient failed to complete Induction therapy within 155 days since treatment initiation due to toxicity or disease progression, unless the delay was a result of non-medical issues (e.g. not due to protocol toxicity). The proportion of patients who successfully received hu14.18K322A with 6 cycles of induction chemotherapy was estimated together with a 95% confidence interval. The response rate (CR + VGPR + PR) to 6 cycles of Induction chemoimmunotherapy was estimated together with the 95% confidence intervals" (NCT01857934)
Timeframe: After 6 cycles of induction therapy (approximately 24 weeks after enrollment)

Interventionpercentage of participants (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A)96.8

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Local Failure Rate and Pattern of Failure

Local failure is defined as relapse or progression of disease at the primary site. The cumulative incidence of local failure will be estimated; competing events will include distant failure or death prior to local failure. (NCT01857934)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody Antibody (hu14.18K322A)1.56

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Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)]

Per the 1993 INRC: measurable tumor defined as product of the longest x widest perpendicular diameter, elevated catecholamine levels and tumor cels in bone marrow. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)->90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; >50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by >50%. Mixed Response (MR)->50% reduction of any measurable lesion with <50% reduction in other sites; no new lesions; <25% increase in any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in an any existing lesion. No Response (NR)-no new lesions; <50% reduction but <25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by >25%; previous negative marrow positive. (NCT01857934)
Timeframe: After two initial courses of chemotherapy (approximately 6 weeks after enrollment)

InterventionParticipants (Count of Participants)
NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A)42

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The Lowest Antibody (Yttrium 90-BC8-DOTA) Dose (mg/kg) That is Consistent With a Favorable Biodistribution Rate >= 80% in Lymphoma Patients

(NCT01921387)
Timeframe: Up to 5 years

Interventionmg/kg (Number)
Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)0.75

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Progression-free Survival Following Autologous Stem Cell Transplant (ASCT)

Estimate the 1 year progression-free survival (PFS) rate after ASCT (NCT01921387)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)12

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Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA

Single patients will be treated at escalating doses in 2-Gy increments (Table 4) until a DLT is observed. Once a DLT is observed, the second stage will begin at the next lower dose level and patients will be treated in cohorts of 4. (NCT01921387)
Timeframe: Within 30 days post-transplant

InterventionGy - MTD (Number)
Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)34

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Estimated Dose to Tumor Sites Based on the Tumor to Normal Organ Ratios Derived From Dosimetry Estimates Coupled With the Absorbed Dose to Normal Organs Based on the Administered Activity of Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8

Will be evaluated among all patients and among those treated at the estimated MTD. (NCT01921387)
Timeframe: Up to 5 years

InterventionmCi (Number)
Treatment (90Y-BC8-DOTA, Chemotherapy, PBSC)52.8

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Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy

The percentage of patients with at least 1 occurrence of grade 3 or higher CTCAE adverse experience will be provided. Ineligible patients or patients who do not receive any protocol therapy are excluded from reporting of adverse events. (NCT02097134)
Timeframe: Up to 30 days after completion of study treatment

InterventionPercentage of patients (Number)
Melphalan38

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Rate of Metastases of Retinoblastoma

The percentage of patients who experience metastases of retinoblastoma will be estimated. Ineligible patients or patients who do not receive any protocol therapy are excluded from this analysis (NCT02097134)
Timeframe: Up to 2 years

InterventionPercentage of Patients (Number)
Melphalan0

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Number of Patients Experiencing Feasibility Failure

Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment. (NCT02097134)
Timeframe: Up to 4 months

Interventionparticipants (Number)
Melphalan4

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Probability of Ocular Salvage

A patient will be considered an ocular-salvage success if enucleation because of disease progression or toxicity is not required during the 2 years following enrollment. (NCT02097134)
Timeframe: 2 years

InterventionPercentage of patients (Number)
Melphalan36

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Number of Participants With Malignant Relapse

"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided" (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment7

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Number of Participants With Event-free Survival (EFS)

"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events 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.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment4

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Number of Participants With Neutrophil Engraftment

Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided. (NCT02199041)
Timeframe: Until day 42 post-transplant

InterventionParticipants (Count of Participants)
Treatment11

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Number of Participants With Overall Survival (OS)

"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events 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 hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided." (NCT02199041)
Timeframe: One year after transplantation

InterventionParticipants (Count of Participants)
Treatment6

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Number of Participants With Secondary Graft Failure

"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
Treatment0

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Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Acute GVHDGrade IGrade IIGrade IIIGrade IV
Treatment80121

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Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT

"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided." (NCT02199041)
Timeframe: 100 days after transplantation

InterventionParticipants (Count of Participants)
No Chronic GVHDMildModerateSevere
Treatment11001

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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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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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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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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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Treatment Responders Using Body Surface Area (BSA) at 12 Months

The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment. (NCT02296164)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
MF-CTCL Patients Receiving Valchlor44

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Overall Survival

Overall survival will be estimated. (NCT02483000)
Timeframe: Up to 4 years

InterventionParticipants (Count of Participants)
Treatment (PRIT)2

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Dosimetry of Yttrium Y 90 DOTA-biotin

Assessed using OLINDA dosimetry software. The estimated dose to normal organs and tumor sites will be described based on the tumor to normal organ ratios derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of yttrium Y 90 DOTA-biotin. (NCT02483000)
Timeframe: Up to 7 days after infusion

InterventioncGy/mCi (Median)
LiverSpleenLungsKidneysBone MarrowBrain
Treatment (PRIT)2.53.730.22911.43.750.229

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Incidence of Toxicity, Defined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Descriptive statistics on the number and percent toxicities will be calculated. (NCT02483000)
Timeframe: Up to 30 days after transplant

InterventionParticipants (Count of Participants)
Serious Adverse EventsOther (Not Including Serious) Adverse Events
Treatment (PRIT)22

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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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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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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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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 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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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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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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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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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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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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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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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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Percentage of Participants Who Achieve a Timely Engraftment

Timely engraftment is defined as a persistent an absolute neutrophil count (ANC) of at least 500 cells/mm3 and a platelet count of at least 20,000 cells/mm3 for at least 3 days (NCT02797470)
Timeframe: 1 month post-transplant

Interventionpercentage of participants who achieve a (Mean)
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio60
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio75
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio100

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Number of Participants Who Survived

Number of Participants Who Survived at day 180. (NCT03019640)
Timeframe: From the time of transplant, assessed up to day 180

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)16

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Disease-free Survival

Number of participants that were in remission post transplant. (NCT03096782)
Timeframe: Up to12 months

InterventionParticipants (Count of Participants)
Complete Remission at 30 daysComplete Remission at 12 months
Chemotherapy Plus Cord Blood Transplant64

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Overall Survival

Number of participants alive 1 year post transplant. (NCT03096782)
Timeframe: Up to 12 months after transplant

InterventionParticipants (Count of Participants)
Chemotherapy Plus Cord Blood Transplant4

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Time to Engraftment

Number of days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days. (NCT03096782)
Timeframe: Up to 12 months after transplant

InterventionParticipants (Count of Participants)
Twenty Two DaysTwenty Nine DaysThirty DaysNine DaysThirty Two Days
Chemotherapy Plus Cord Blood Transplant21111

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Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as >25 by SCORD. (NCT03380026)
Timeframe: 4 months

Interventionpatients (Number)
Valchlor 0.016% Topical Gel16
Valchlor Plus Triamcinolone11

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Severity of Dermatitis

"Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score A. The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, B. Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score C. The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome.~A lower score would be a better outcome." (NCT03380026)
Timeframe: 4 months

Interventionscore on a scale (Mean)
Valchlor 0.016% Topical Gel24.8
Valchlor Plus Triamcinolone12.7

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Efficacy of Valchlor vs Valchlor Plus Triamcinolone

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is >1.0 will indicate worsening of disease. (NCT03380026)
Timeframe: 4 months

,
InterventionCAILS score (Mean)
Average CAILS score at BaselineAverage CAILS score at Month 4
Valchlor 0.016% Topical Gel8.611.4
Valchlor Plus Triamcinolone7.012.0

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Change in Dermatology Quality of Life Index (DQLI)

The DQLI is 10 standardized items measuring impact of skin disease rated as 0=not at all/not relevant; 1=a little; 2=a lot; 3=very much. The absolute change of total DQLI score from before and after treatment (NCT03417141)
Timeframe: baseline, 24 weeks

Interventionscore on a scale (Median)
Valchor Treatment of Lichen Planopilaris-2

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Change in Lichen Planopilaris Activity Index (LLPAI)

The Lichen Planopilaris Activity Index is a standardized validated quantitative measure of disease activity. LPPAI score (0-10) is calculated as follows: (pruritus + pain + burning)/3 + (scalp erythema + perifollicular erythema + perifollicular scale)/3 + 2.5 (pull test) + 1.5 (spreading/2). Symptoms and signs are graded on a 4-point scale with 0 = absent, 1 = mild, 2 = moderate, and 3 =severe. Clinical progression and a positive hair pull test are graded 1=yes; 0=no. The percent change of LLPAI score from before and after treatment. (NCT03417141)
Timeframe: baseline, up to 24 weeks

Interventionpercentage of change from baseline (Median)
Week 12Week 24
Valchor Treatment of Lichen Planopilaris-42.9-66.7

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Change in Mean Follicular Density

Phototrichograms of all subjects scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the mean number of follicular units per square cm was measured before and after treatment. (NCT03417141)
Timeframe: baseline, 24 weeks

Interventionpercent change (Median)
Valchor Treatment of Lichen Planopilaris-9.0

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Change in Follicular Units

Phototrichograms of all subjects scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per square cm was measured before and after treatment. (NCT03417141)
Timeframe: baseline, 24 weeks

Interventionpercent change (Median)
Valchor Treatment of Lichen Planopilaris-9.1

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"Percentage of Participants Who Are Feasibility Failure"

"Feasibility failures were defined as patients that did not receive >= 75% of the planned dinutuximab doses during Induction cycles 3-5. Assessed by estimation of the feasibility failure rate together with a 95% confidence interval." (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

InterventionPercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)0.0

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Event-free Survival

Per the revised INRC, progressive disease is: 1) > 20% increase in the longest diameter of the primary tumor, taking as reference the smallest sum and ¬> increase of 5 mm in longest dimension, 2) Any new soft tissue lesion detected by CT/MRI that is MIBG avid or FDG-PET avid, 3) Any new soft tissue lesion seen on CT/MRI that is biopsied and found to be neuroblastoma or ganglioneuroblastoma, 4) Any new bone site that is MIBG avid, 5) Any new bone site that is FDG-PET avid and has CT/MRI findings of tumor or is histologically neuroblastoma or ganglioneuroblastoma 6) A metastatic soft tissue site with > 20% increase in longest diameter, taking as reference the smallest sum on study, and with > 5mm in sum of diameters of target soft tissue lesions, 7) A relative MIBG score ¬> 1.2, 8) Bone marrow without tumor infiltration that becomes >5% tumor infiltration, 9) Bone marrow with tumor infiltration that increases by > 2-fold and has > 20% tumor infiltration on reassessment. (NCT03786783)
Timeframe: Up to 1 year

InterventionPercent Probability (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)82.6

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Overall Survival

Kaplan-Meier method was used to estimate overall survival (OS). OS was defined as the time from study enrollment to death. 1-year OS is provided. (NCT03786783)
Timeframe: Up to 1 year

InterventionPercent Probability (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)95.0

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Percentage of Participants With Unacceptable Toxicity

Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

Interventionpercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)0.0

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Response Rate

Per the revised INRC, response is comprised by responses in 3 components: primary tumor, soft tissue and bone metastases, and bone marrow. Primary and metastatic soft tissue sites were assessed using Response Evaluation Criteria in Solid Tumors and MIBG scans or FDG-PET scans if the tumor was MIBG non-avid. Bone marrow was assessed by histology or immunohistochemistry and cytology or immunocytology. Complete response (CR) - All components meet criteria for CR. Partial response (PR) - PR in at least one component and all other components are either CR, minimal disease (in bone marrow), PR (soft tissue or bone) or not involved (NI; no component with progressive disease (PD). Minor response (MR) - PR or CR in at least one component but at least one other component with stable disease; no component with PD. Stable disease (SD) - Stable disease in one component with no better than SD or NI in any other component; no component with PD. Progressive disease (PD) - Any component with PD. (NCT03786783)
Timeframe: Up to the first 5 cycles of treatment

InterventionPercentage of patients (Number)
Treatment(Chemotherapy, Dinutuximab, Sargramostim, ASCT, EBRT)78.6

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Number of Patients With a Partial Response

The proportion of each type of response with a 95% CI will be reported for all evaluable patients, assuming a binomial distribution. (NCT04205240)
Timeframe: Approximately 11 months

Interventionpatients (Number)
Treatment (Conditioning Regimen, Stem Cell Transplant)1

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Number of Patients With Grade II-IV Acute Graft-versus Host Disease (GvHD (aGVHD)

The event will be onset of grade II-IV aGvHD and time to aGvHD will be defined as the period of time from transplantation to the event of aGvHD. Death and early relapse without aGvHD will be competing risks. Cumulative incidence rate of aGVHD with 95% confidence intervals will be estimated from the cumulative incidence curves. To evaluate the association between patient characteristics and aGVHD, the Gray's test accounting for competing risks will be used to compare the cumulative incidence curves and a proportional hazards model for the sub distribution of competing risks will be used to estimate the hazard ratio. The cumulative incidence of chronic GVHD (cGVHD) will be similarly analyzed. (NCT04205240)
Timeframe: Up to 6 weeks

Interventionparticipants (Number)
Treatment (Conditioning Regimen, Stem Cell Transplant)0

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Progression Free Survival (PFS)

Kaplan-Meier curve will be generated for PFS. (NCT04339101)
Timeframe: From the date of stem cell infusion to the date of death, disease relapse/progression, or last follow-up, whichever occurs first, assessed at 1 year post transplant

Interventionpercentage of probability (Number)
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus)70

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Cumulative Incidence of Grade II-IV Acute GVHD

Acute GVHD will be graded and staged according to the Consensus Grading. (NCT04339101)
Timeframe: From day 0 (date of stem cell infusion) through 100 days post-transplant

Interventionpercentage of probability (Number)
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus)4

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Graft-versus-host Disease Free Relapse Free (GRFS) at 1 Year

GRFS is defined as time from the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first. Kaplan-Meier curve will be generated for GRFS. (NCT04339101)
Timeframe: From the date of transplantation to the first time of observing following events: grade 3-4 acute graft versus host disease (GVHD), chronic GVHD requiring systemic treatment, relapse, or death, whichever occurs first, assessed at 1 year post transplant.

Interventionpercentage of probability (Number)
Treatment (Itacitinib Adipate, Tacrolimus, Sirolimus)56

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