Page last updated: 2024-11-04

etoposide phosphate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Etoposide phosphate is a water-soluble prodrug of etoposide, a topoisomerase II inhibitor used in the treatment of various cancers. Etoposide phosphate is synthesized by reacting etoposide with phosphoric acid. It is converted to etoposide in the body, which then inhibits the enzyme topoisomerase II. Topoisomerase II is essential for DNA replication and repair. By inhibiting topoisomerase II, etoposide phosphate prevents DNA replication and leads to cell death. Etoposide phosphate is studied extensively for its potential in treating various cancers, including lung cancer, testicular cancer, and lymphoma. It is often used in combination with other chemotherapeutic agents. Etoposide phosphate is a promising treatment option for a variety of cancers and is an important area of ongoing research.'

Cross-References

ID SourceID
PubMed CID6918092
CHEMBL ID1200645
CHEBI ID135867
SCHEMBL ID13318053
MeSH IDM0170292
PubMed CID4407
CHEMBL ID310396
CHEMBL ID1529933
SCHEMBL ID197302
SCHEMBL ID13907269
MeSH IDM0170292

Synonyms (73)

Synonym
bmy-40481
vepeside
etoposide phosphate (usan)
117091-64-2
etopophos (tn)
D04107
vp16
etoposide phosphate
etopophos preservative free
4'-demethylepipodophyllotoxin 9-(4,6-o-(r)-ethylidene-beta-d-glucopyranoside), 4'-(dihydrogen phosphate)
etophos
etopofos
bmy 40481
furo(3',4':6,7)naphtho(2,3-d)-1,3-dioxol-6(5ah)-one, 5-(3,5-dimethoxy-4-(phosphonooxy)phenyl)-9-((4,6-o-ethylidene-beta-d-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-, (5r-(5alpha,5abeta,8aalpha,9beta(r*)))-
etoposide phosphate [usan]
CHEBI:135867
CHEMBL1200645
unii-528xyj8l1n
528xyj8l1n ,
furo(3',4':6,7)naphtho(2,3-d)-1,3-dioxol-6(5ah)-one, 5-(3,5-dimethoxy-4-(phosphonooxy)phenyl)-9-((4,6-o-ethylidene-.beta.-d-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-, (5r-(5.alpha.,5a.beta.,8a.alpha.,9.beta.(r*)))-
etoposide phosphate [usp-rs]
etoposide phosphate [orange book]
4'-demethylepipodophyllotoxin 9-(4,6-o-(r)-ethylidene-.beta.-d-glucopyranoside), 4'-(dihydrogen phosphate)
etoposide phosphate [mart.]
etoposide phosphate [mi]
etoposide phosphate [usp monograph]
etoposide phosphate [who-dd]
etoposide phosphate [vandf]
etoposide 4'-phosphate
SCHEMBL13318053
AKOS025311200
J-003505
bdbm50247889
EX-A3595
AS-12896
etoposide-phosphate
eposin etopophos vepesid vp16
NCGC00185753-04
Q27260984
furo[3',4':6,7]naphtho[2,3-d]-1,3-dioxol-6(5ah)-one, 5-[3,5-dimethoxy-4-(phosphonooxy)phenyl]-9-[[4,6-o-(1r)-ethylidene-?-d-glucopyranosyl]oxy]-5,8,8a,9-tetrahydro-, (5r,5ar,8ar,9s)-; etoposide phosphate; etopofos; etopophos
etoposide phosphate (etopophos)
CS-0007496
HY-13630
etoposide phosphate (usp monograph)
etoposide phosphate (usp-rs)
etoposide phosphate (mart.)
6,7-dichloro-5,8-dihydroxynaphthalene-1,4-dione
CHEMBL310396
BRD-K18677154-001-01-2
HSCI1_000029
2,3-dichloro-5,8-dihydroxy-1,4-naphthoquinone, 95%
NCGC00095293-01
2,3-dichloro-5,8-dihydroxy-1,4-naphthoquinone
NCGC00095293-02
SPECTRUM1505158 ,
D2421
14918-69-5
AKOS004907772
NCGC00095293-03
2,3-dichloro-5,8-dihydroxynaphthalene-1,4-dione
SCHEMBL197302
SCHEMBL13907269
2,3-dichloro-5,8-dihydroxynapthoquinone
UVESKDKGJSABKP-UHFFFAOYSA-N
mfcd00075261
AS-67354
bdbm50505246
2,3-dichloro-5,8-dihydroxy-naphthalene-1,4-dione
1,4-naphthalenedione, 2,3-dichloro-5,8-dihydroxy-
5,8-dihydroxy-6,7-dichloro-1,4-naphthoquinone
2,3-dichloro-5,8-dihydroxy-1,4-dihydronaphthalene-1,4-dione
F19943
CHEMBL1529933 ,

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" EP shows better chemical and physical properties, is said to be less toxic but is five times more expensive than VP16."( Particular cutaneous side effects with etoposide-containing courses: is VP16 or etoposide phosphate responsible?
Aubin, F; Burgot, G; Gandemer, V; Le Gall, E; Marigny, K, 2005
)
0.33
" The medical files of 36 children (88 EP courses, 25 VP16 courses) included in these protocols were analysed on the basis that if a child showed a side effect during a course, the child had to have recovered from that side effect before the beginning of the next course."( Particular cutaneous side effects with etoposide-containing courses: is VP16 or etoposide phosphate responsible?
Aubin, F; Burgot, G; Gandemer, V; Le Gall, E; Marigny, K, 2005
)
0.33
"Combined carboplatin and VP16P may be compatible for intravitreal injection therapy, and a single dose of 2 µg/25 µg appears to be safe in a rabbit model."( Preclinical Acute Ocular Safety Study of Combined Intravitreal Carboplatin and Etoposide Phosphate for Retinoblastoma.
Elner, VM; Harbour, JW; Mohney, BG; Musch, DC; Smith, AB; Smith, BD; Smith, SJ, 2017
)
0.46
" Adverse effects were graded according to the Veterinary Cooperative Oncology Group criteria."( Dose escalation study to evaluate safety, tolerability and efficacy of intravenous etoposide phosphate administration in 27 dogs with multicentric lymphoma.
Bouchaert, E; Boyé, P; Gomes, B; Hordeaux, J; Marescaux, L; Serres, F; Tierny, D, 2017
)
0.46

Pharmacokinetics

The clinical and pharmacokinetic results of this study confirm the prodrug hypothesis of etoposide phosphate. Plasma concentrations and pharmacokeretic parameters of eto-phosphorus were comparable to those reported for etopOSide.

ExcerptReferenceRelevance
" Pharmacokinetic parameters were calculated by a noncompartmental method."( Pharmacokinetics and bioequivalence of etoposide following intravenous administration of etoposide phosphate and etoposide in patients with solid tumors.
Bukowski, R; Fields, SZ; Gandara, D; Goss, G; Igwemezie, LN; Kaul, S; Kosty, M; Levithan, N; O'Dwyer, P; Stewart, DJ, 1995
)
0.29
" Mean terminal elimination half-life (t1/2), steady-state volume of distribution (Vss), and total systemic clearance (CL) values of etoposide were approximately 7 hours, 7 L/m2, and 17 mL/min/m2 after Etopophos and VePesid treatments, respectively."( Pharmacokinetics and bioequivalence of etoposide following intravenous administration of etoposide phosphate and etoposide in patients with solid tumors.
Bukowski, R; Fields, SZ; Gandara, D; Goss, G; Igwemezie, LN; Kaul, S; Kosty, M; Levithan, N; O'Dwyer, P; Stewart, DJ, 1995
)
0.29
"To determine the bioavailability (F) and the pharmacokinetic profile of both etoposide and its prodrug, etoposide phosphate, after oral and intravenous administration of etoposide phosphate, and to determine the maximum-tolerable dose (MTD) of oral etoposide phosphate administered daily for 5 consecutive days every 3 weeks."( Phase I clinical and pharmacokinetic study of oral etoposide phosphate.
Cavalli, F; Cerny, T; De Fusco, M; De Jong, J; Gentili, D; McDaniel, C; Pagani, O; Prins, C; Sessa, C; Zucchetti, M, 1995
)
0.29
"In the F part of the study, patients were assessed for pharmacokinetic studies after one oral and one intravenous administration of the same dose of etoposide phosphate."( Phase I clinical and pharmacokinetic study of oral etoposide phosphate.
Cavalli, F; Cerny, T; De Fusco, M; De Jong, J; Gentili, D; McDaniel, C; Pagani, O; Prins, C; Sessa, C; Zucchetti, M, 1995
)
0.29
" Plasma concentrations and pharmacokinetic parameters of etoposide following etoposide phosphate were comparable to those reported for etoposide."( Phase I clinical and pharmacokinetic study of oral etoposide phosphate.
Cavalli, F; Cerny, T; De Fusco, M; De Jong, J; Gentili, D; McDaniel, C; Pagani, O; Prins, C; Sessa, C; Zucchetti, M, 1995
)
0.29
"The clinical and pharmacokinetic results of this study confirm the prodrug hypothesis of etoposide phosphate."( Phase I clinical and pharmacokinetic study of oral etoposide phosphate.
Cavalli, F; Cerny, T; De Fusco, M; De Jong, J; Gentili, D; McDaniel, C; Pagani, O; Prins, C; Sessa, C; Zucchetti, M, 1995
)
0.29
" formulation has focused on the identification of the maximum tolerated dose (MTD) and pharmacokinetic characteristics of the drug using a 5 daily dose schedule and a days 1, 3, and 5 schedule, with the drug being given over 30 or 5 (bolus) min."( Clinical and pharmacokinetic overview of parenteral etoposide phosphate.
Albert, E; Igwemezie, LN; Morgenthien, E; Randolph, J; Santabárbara, P; Schacter, LP; Seyedsadr, M, 1994
)
0.29
" A phase I and pharmacokinetic study has been performed over the dose range 25-110 mg/m2/day for 5 days (etoposide equivalent doses)."( Phase I and pharmacokinetic study of a water-soluble etoposide prodrug, etoposide phosphate (BMY-40481).
Balmanno, K; Chapman, F; Charlton, CJ; Gumbrell, L; Igwemezie, LN; Lind, MJ; Millward, MJ; Mummaneni, V; Newell, DR; Proctor, M, 1995
)
0.29
" For pharmacokinetic studies of etoposide phosphate in this phase I study, 21 patients with solid tumors were treated with etoposide phosphate given as etoposide equivalents of 250, 500, 750, 1000 and 1200 mg/m2 infused over 2 h on days 1 and 2, and G-CSF 5 micrograms/kg per day starting on day 3 until WBC was > or = 10,000/microliters."( Pharmacokinetic evaluation of high-dose etoposide phosphate after a 2-hour infusion in patients with solid tumors.
Baer, J; Budman, DR; Fields, SZ; Hock, K; Ingram, R; Kreis, W; Schacter, LP; Vinciguerra, V, 1996
)
0.29
" We performed a phase I pharmacokinetic study in 27 patients."( Phase I and pharmacokinetic study of etoposide phosphate.
Alberts, DS; Barbhaiya, RH; Brooks, DJ; Igwemzie, LM; Kaul, S; McKinney, LM; Randolph, J; Schacter, L; Srinivas, NR; Thomas, T, 1995
)
0.29
" Both linear and nonlinear pharmacodynamic models were used to evaluate the relationship between hematologic toxicity and etoposide AUC and patient factors (age, gender, performance status, prior radiation therapy, prior chemotherapy, baseline albumin, bilirubin, alkaline phosphatase, creatinine, leukocyte count, granulocyte count)."( A pharmacodynamic evaluation of hematologic toxicity observed with etoposide phosphate in the treatment of cancer patients.
Barbhaiya, RH; Igwemezie, LN; Kaul, S; Srinivas, NR, 1996
)
0.29
" The gender- and age-related differences observed in the pharmacokinetic parameters of etoposide were significant but generally of a small magnitude (< or = 13%), indicating no need for dose adjustment in these patient populations."( Effects of gender, age, and race on the pharmacokinetics of etoposide after intravenous administration of etoposide phosphate in cancer patients.
Barbhaiya, RH; Igwemezie, LN; Kaul, S; Mummaneni, V; Srinivas, NR, 1996
)
0.29
" Resulting data were subjected to noncompartmental pharmacokinetic analysis."( Bioequivalence assessment of etoposide phosphate and etoposide using pharmacodynamic and traditional pharmacokinetic parameters.
Barbhaiya, RH; Calvert, AH; Igwemezie, LN; Kaul, S; Mummaneni, V; Newell, DR; Porter, D; Thomas, H; Winograd, B, 1996
)
0.29
" The pharmacodynamic relationships observed suggest the possibility of pharmacologically based dosing of EP."( Phase I and pharmacokinetic study of etoposide phosphate by protracted venous infusion in patients with advanced cancer.
Creaven, PJ; Gunton, KE; Meropol, NJ; Noel, D; Pendyala, L; Schacter, LP; Soni, N, 1997
)
0.3
" Pharmacokinetic adjustment to specific plasma concentrations may make it possible to define a therapeutic plasma concentration and relate drug target expression in the tumor to response."( Pharmacokinetic study of cisplatin and infusional etoposide phosphate in advanced breast cancer with correlation of response to topoisomerase IIalpha expression.
Braybrooke, JP; Davis, T; Harris, AL; Joel, S; Levitt, NC; Madhusudan, S; Talbot, DC; Turley, H; Wilner, S, 2003
)
0.32
" Targeting plasma etoposide concentration reduced interpatient pharmacokinetic variability (32% and 62% of patients, respectively, within 10% of target concentration on days 2 and 4; cycle 1)."( Pharmacokinetic study of cisplatin and infusional etoposide phosphate in advanced breast cancer with correlation of response to topoisomerase IIalpha expression.
Braybrooke, JP; Davis, T; Harris, AL; Joel, S; Levitt, NC; Madhusudan, S; Talbot, DC; Turley, H; Wilner, S, 2003
)
0.32

Compound-Compound Interactions

Etoposide phosphate in combination with any other agent was observed to be highly neurotoxic if both agents were administered after BBBD.

ExcerptReferenceRelevance
" It was given in combination with carboplatin, which was dosed on an AUC basis."( Etoposide phosphate infusion with therapeutic drug monitoring in combination with carboplatin dosed by area under the curve: a cancer research campaign phase I/II committee study.
Abrahamsen, D; Boddy, A; Brampton, M; Calvert, AH; Lind, M; Newell, D; Porter, D; Robson, L; Thomas, H; Winograd, B, 1996
)
0.29
" This clinical investigation assessed the efficacy and toxicity of etoposide phosphate combined with cisplatin in treating SCLC."( A pharmacoeconomic evaluation of cisplatin in combination with either etoposide or etoposide phosphate in small cell lung cancer.
Dezii, CM; Doyle, JJ; Sadana, A, 1996
)
0.29
" Etoposide phosphate in combination with any other agent was observed to be highly neurotoxic if both agents were administered after BBBD."( Unexpected neurotoxicity of etoposide phosphate administered in combination with other chemotherapeutic agents after blood-brain barrier modification to enhance delivery, using propofol for general anesthesia, in a rat model.
Fortin, D; McCormick, CI; Neuwelt, EA; Nixon, R; Remsen, LG, 2000
)
0.31

Bioavailability

The purpose of this study was to determine the bioavailability (F) of etoposide (E;VP-16) after oral administration of the water-soluble prodrug etopOSide phosphate (EP;BMY-40481) during a phase I trial in cancer patients.

ExcerptReferenceRelevance
" The mean bioavailability of etoposide from Etopophos, relative to VePesid, was 103% (90% confidence interval, 99% to 106%) based on Cmax, and 107% (90 confidence interval, 105% to 110%) based on area under the concentration versus time curve from zero to infinity (AUCinf) values."( Pharmacokinetics and bioequivalence of etoposide following intravenous administration of etoposide phosphate and etoposide in patients with solid tumors.
Bukowski, R; Fields, SZ; Gandara, D; Goss, G; Igwemezie, LN; Kaul, S; Kosty, M; Levithan, N; O'Dwyer, P; Stewart, DJ, 1995
)
0.29
"To determine the bioavailability (F) and the pharmacokinetic profile of both etoposide and its prodrug, etoposide phosphate, after oral and intravenous administration of etoposide phosphate, and to determine the maximum-tolerable dose (MTD) of oral etoposide phosphate administered daily for 5 consecutive days every 3 weeks."( Phase I clinical and pharmacokinetic study of oral etoposide phosphate.
Cavalli, F; Cerny, T; De Fusco, M; De Jong, J; Gentili, D; McDaniel, C; Pagani, O; Prins, C; Sessa, C; Zucchetti, M, 1995
)
0.29
"The purpose of this study was to determine the bioavailability (F) of etoposide (E;VP-16) after oral administration of the water-soluble prodrug etoposide phosphate (EP;BMY-40481) during a phase I trial in cancer patients."( Etoposide bioavailability after oral administration of the prodrug etoposide phosphate in cancer patients during a phase I study.
Abigerges, D; Armand, JP; Bonnay, M; Chabot, GG; de Forni, M; Igwemezie, L; Kaul, S; Ropers, J; Schacter, L; Terret, C; Winograd, B, 1996
)
0.29
" Oral bioavailability is variable, and protracted intravenous administration is limited by water insolubility, which requires large infusion volumes."( Phase I and pharmacokinetic study of etoposide phosphate by protracted venous infusion in patients with advanced cancer.
Creaven, PJ; Gunton, KE; Meropol, NJ; Noel, D; Pendyala, L; Schacter, LP; Soni, N, 1997
)
0.3
" It was expected that this prodrug could be used to overcome the solubility limitations and erratic bioavailability of oral etoposide."( Conversion of the prodrug etoposide phosphate to etoposide in gastric juice and bile.
de Jong, RS; de Vries, EG; Mulder, NH; Slijfer, EA; Uges, DR, 1997
)
0.3

Dosage Studied

Rapid conversion of etoposide phosphate into etopOSide by dephosphorylation occurred at all dosage levels without indication of saturation of phosphatases. The treatment was administered using an adaptive dosing strategy.

ExcerptRelevanceReference
" The feasibility of bolus dosing and treatment at high concentrations has been demonstrated, with no effects on the cardiovascular system being noted."( Clinical and pharmacokinetic overview of parenteral etoposide phosphate.
Albert, E; Igwemezie, LN; Morgenthien, E; Randolph, J; Santabárbara, P; Schacter, LP; Seyedsadr, M, 1994
)
0.29
" Rapid conversion of etoposide phosphate into etoposide by dephosphorylation occurred at all dosage levels without indication of saturation of phosphatases."( Pharmacokinetic evaluation of high-dose etoposide phosphate after a 2-hour infusion in patients with solid tumors.
Baer, J; Budman, DR; Fields, SZ; Hock, K; Ingram, R; Kreis, W; Schacter, LP; Vinciguerra, V, 1996
)
0.29
" The etoposide prodrug etoposide phosphate (Etopophos; Bristol-Myers Squibb Company, Princeton, NJ) was administered by infusion using an adaptive dosing strategy."( Etoposide phosphate infusion with therapeutic drug monitoring in combination with carboplatin dosed by area under the curve: a cancer research campaign phase I/II committee study.
Abrahamsen, D; Boddy, A; Brampton, M; Calvert, AH; Lind, M; Newell, D; Porter, D; Robson, L; Thomas, H; Winograd, B, 1996
)
0.29
" The pharmacodynamic relationships observed suggest the possibility of pharmacologically based dosing of EP."( Phase I and pharmacokinetic study of etoposide phosphate by protracted venous infusion in patients with advanced cancer.
Creaven, PJ; Gunton, KE; Meropol, NJ; Noel, D; Pendyala, L; Schacter, LP; Soni, N, 1997
)
0.3
"First a sequential dose-response was assessed with flash electroretinogram for both eyes of light- and dark-adapted rabbits (n = 7; one rabbit for each dose) over a range of light intensities before and after intravitreal injection of VP16 or VP16P to one eye; the other eye was injected with normal saline as a control."( Etoposide as a virocidal anticytomegalovirus therapy: intravitreal toxicology and pharmacology in rabbits.
Coroneo, M; Crouch, R; Graham, G; Morlet, N; Naidoo, D; Salonikas, C; Stayt, J, 1999
)
0.3
"This study shows that EP at high dosage or one of its excipients is probably responsible for AKI, as compared to CY."( Acute kidney injury after high dose etoposide phosphate: A retrospective study in children receiving an allogeneic hematopoetic stem cell transplantation.
Barnoud, D; Barthélémy, C; Béné, J; Bruno, B; Décaudin, B; Gautier, S; Lahoche, A; Odou, P; Petitpain, N; Pinçon, C; Simon, N; Vasseur, M, 2018
)
0.48
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
furonaphthodioxole
[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 (51)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
Chain A, Breast cancer type 1 susceptibility proteinHomo sapiens (human)Potency31.62281.258920.440939.8107AID875; AID892
Chain A, Putative fructose-1,6-bisphosphate aldolaseGiardia intestinalisPotency12.55940.140911.194039.8107AID2451
Chain A, HADH2 proteinHomo sapiens (human)Potency3.16230.025120.237639.8107AID893
Chain B, HADH2 proteinHomo sapiens (human)Potency3.16230.025120.237639.8107AID893
15-lipoxygenase, partialHomo sapiens (human)Potency1.00000.012610.691788.5700AID887
phosphopantetheinyl transferaseBacillus subtilisPotency11.22020.141337.9142100.0000AID1490
USP1 protein, partialHomo sapiens (human)Potency56.23410.031637.5844354.8130AID504865
TDP1 proteinHomo sapiens (human)Potency1.43980.000811.382244.6684AID686978; AID686979
Microtubule-associated protein tauHomo sapiens (human)Potency0.89130.180013.557439.8107AID1460
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency1.25890.011212.4002100.0000AID1030
alpha-galactosidaseHomo sapiens (human)Potency15.84894.466818.391635.4813AID2107
Bloom syndrome protein isoform 1Homo sapiens (human)Potency39.81070.540617.639296.1227AID2528
cellular tumor antigen p53 isoform aHomo sapiens (human)Potency31.62280.316212.443531.6228AID902; AID924
polyunsaturated fatty acid lipoxygenase ALOX12Homo sapiens (human)Potency19.95261.000012.232631.6228AID1452
15-hydroxyprostaglandin dehydrogenase [NAD(+)] isoform 1Homo sapiens (human)Potency3.54810.001815.663839.8107AID894
vitamin D3 receptor isoform VDRAHomo sapiens (human)Potency4.46680.354828.065989.1251AID504847
thyroid hormone receptor beta isoform aHomo sapiens (human)Potency0.00320.010039.53711,122.0200AID1479
mitogen-activated protein kinase 1Homo sapiens (human)Potency20.40530.039816.784239.8107AID1454; AID995
ubiquitin carboxyl-terminal hydrolase 2 isoform aHomo sapiens (human)Potency10.00000.65619.452025.1189AID927
nuclear receptor ROR-gamma isoform 1Mus musculus (house mouse)Potency22.38720.00798.23321,122.0200AID2551
DNA polymerase kappa isoform 1Homo sapiens (human)Potency7.07950.031622.3146100.0000AID588579
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency31.62280.031610.279239.8107AID884; AID885
histone acetyltransferase KAT2A isoform 1Homo sapiens (human)Potency19.95260.251215.843239.8107AID504327
lamin isoform A-delta10Homo sapiens (human)Potency7.94330.891312.067628.1838AID1487
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Integrin beta-3Homo sapiens (human)Potency31.62280.316211.415731.6228AID924
Integrin alpha-IIbHomo sapiens (human)Potency31.62280.316211.415731.6228AID924
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Platelet-activating factor receptorHomo sapiens (human)Potency31.622810.000025.781039.8107AID892
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Disintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)Potency10.00001.584913.004325.1189AID927
Inositol monophosphatase 1Rattus norvegicus (Norway rat)Potency10.00001.000010.475628.1838AID1457
GABA theta subunitRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency31.62281.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

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

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
G-protein coupled receptor 55Homo sapiens (human)EC50 (µMol)20.00000.00200.66622.0100AID1525077
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (179)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of low-density lipoprotein receptor activityIntegrin beta-3Homo sapiens (human)
positive regulation of protein phosphorylationIntegrin beta-3Homo sapiens (human)
positive regulation of endothelial cell proliferationIntegrin beta-3Homo sapiens (human)
positive regulation of cell-matrix adhesionIntegrin beta-3Homo sapiens (human)
cell-substrate junction assemblyIntegrin beta-3Homo sapiens (human)
cell adhesionIntegrin beta-3Homo sapiens (human)
cell-matrix adhesionIntegrin beta-3Homo sapiens (human)
integrin-mediated signaling pathwayIntegrin beta-3Homo sapiens (human)
embryo implantationIntegrin beta-3Homo sapiens (human)
blood coagulationIntegrin beta-3Homo sapiens (human)
positive regulation of endothelial cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of gene expressionIntegrin beta-3Homo sapiens (human)
negative regulation of macrophage derived foam cell differentiationIntegrin beta-3Homo sapiens (human)
positive regulation of fibroblast migrationIntegrin beta-3Homo sapiens (human)
negative regulation of lipid storageIntegrin beta-3Homo sapiens (human)
response to activityIntegrin beta-3Homo sapiens (human)
smooth muscle cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of smooth muscle cell migrationIntegrin beta-3Homo sapiens (human)
platelet activationIntegrin beta-3Homo sapiens (human)
positive regulation of vascular endothelial growth factor receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
cell-substrate adhesionIntegrin beta-3Homo sapiens (human)
activation of protein kinase activityIntegrin beta-3Homo sapiens (human)
negative regulation of lipid transportIntegrin beta-3Homo sapiens (human)
regulation of protein localizationIntegrin beta-3Homo sapiens (human)
regulation of actin cytoskeleton organizationIntegrin beta-3Homo sapiens (human)
cell adhesion mediated by integrinIntegrin beta-3Homo sapiens (human)
positive regulation of cell adhesion mediated by integrinIntegrin beta-3Homo sapiens (human)
positive regulation of osteoblast proliferationIntegrin beta-3Homo sapiens (human)
heterotypic cell-cell adhesionIntegrin beta-3Homo sapiens (human)
substrate adhesion-dependent cell spreadingIntegrin beta-3Homo sapiens (human)
tube developmentIntegrin beta-3Homo sapiens (human)
wound healing, spreading of epidermal cellsIntegrin beta-3Homo sapiens (human)
cellular response to platelet-derived growth factor stimulusIntegrin beta-3Homo sapiens (human)
apolipoprotein A-I-mediated signaling pathwayIntegrin beta-3Homo sapiens (human)
wound healingIntegrin beta-3Homo sapiens (human)
apoptotic cell clearanceIntegrin beta-3Homo sapiens (human)
regulation of bone resorptionIntegrin beta-3Homo sapiens (human)
positive regulation of angiogenesisIntegrin beta-3Homo sapiens (human)
positive regulation of bone resorptionIntegrin beta-3Homo sapiens (human)
symbiont entry into host cellIntegrin beta-3Homo sapiens (human)
platelet-derived growth factor receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
positive regulation of fibroblast proliferationIntegrin beta-3Homo sapiens (human)
mesodermal cell differentiationIntegrin beta-3Homo sapiens (human)
positive regulation of smooth muscle cell proliferationIntegrin beta-3Homo sapiens (human)
positive regulation of peptidyl-tyrosine phosphorylationIntegrin beta-3Homo sapiens (human)
negative regulation of lipoprotein metabolic processIntegrin beta-3Homo sapiens (human)
negative chemotaxisIntegrin beta-3Homo sapiens (human)
regulation of release of sequestered calcium ion into cytosolIntegrin beta-3Homo sapiens (human)
regulation of serotonin uptakeIntegrin beta-3Homo sapiens (human)
angiogenesis involved in wound healingIntegrin beta-3Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeIntegrin beta-3Homo sapiens (human)
platelet aggregationIntegrin beta-3Homo sapiens (human)
cellular response to mechanical stimulusIntegrin beta-3Homo sapiens (human)
cellular response to xenobiotic stimulusIntegrin beta-3Homo sapiens (human)
positive regulation of glomerular mesangial cell proliferationIntegrin beta-3Homo sapiens (human)
blood coagulation, fibrin clot formationIntegrin beta-3Homo sapiens (human)
maintenance of postsynaptic specialization structureIntegrin beta-3Homo sapiens (human)
regulation of postsynaptic neurotransmitter receptor internalizationIntegrin beta-3Homo sapiens (human)
regulation of postsynaptic neurotransmitter receptor diffusion trappingIntegrin beta-3Homo sapiens (human)
positive regulation of substrate adhesion-dependent cell spreadingIntegrin beta-3Homo sapiens (human)
positive regulation of adenylate cyclase-inhibiting opioid receptor signaling pathwayIntegrin beta-3Homo sapiens (human)
regulation of trophoblast cell migrationIntegrin beta-3Homo sapiens (human)
regulation of extracellular matrix organizationIntegrin beta-3Homo sapiens (human)
cellular response to insulin-like growth factor stimulusIntegrin beta-3Homo sapiens (human)
negative regulation of endothelial cell apoptotic processIntegrin beta-3Homo sapiens (human)
positive regulation of T cell migrationIntegrin beta-3Homo sapiens (human)
cell migrationIntegrin beta-3Homo sapiens (human)
positive regulation of leukocyte migrationIntegrin alpha-IIbHomo sapiens (human)
cell-matrix adhesionIntegrin alpha-IIbHomo sapiens (human)
integrin-mediated signaling pathwayIntegrin alpha-IIbHomo sapiens (human)
angiogenesisIntegrin alpha-IIbHomo sapiens (human)
cell-cell adhesionIntegrin alpha-IIbHomo sapiens (human)
cell adhesion mediated by integrinIntegrin alpha-IIbHomo sapiens (human)
positive regulation of cellular extravasationPlatelet-activating factor receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIPlatelet-activating factor receptorHomo sapiens (human)
chemotaxisPlatelet-activating factor receptorHomo sapiens (human)
inflammatory responsePlatelet-activating factor receptorHomo sapiens (human)
immune responsePlatelet-activating factor receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayPlatelet-activating factor receptorHomo sapiens (human)
parturitionPlatelet-activating factor receptorHomo sapiens (human)
response to symbiotic bacteriumPlatelet-activating factor receptorHomo sapiens (human)
lipopolysaccharide-mediated signaling pathwayPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of interleukin-6 productionPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of tumor necrosis factor productionPlatelet-activating factor receptorHomo sapiens (human)
inositol trisphosphate biosynthetic processPlatelet-activating factor receptorHomo sapiens (human)
G protein-coupled purinergic nucleotide receptor signaling pathwayPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of neutrophil degranulationPlatelet-activating factor receptorHomo sapiens (human)
transcytosisPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of translationPlatelet-activating factor receptorHomo sapiens (human)
negative regulation of blood pressurePlatelet-activating factor receptorHomo sapiens (human)
positive regulation of smooth muscle cell proliferationPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of inositol phosphate biosynthetic processPlatelet-activating factor receptorHomo sapiens (human)
cellular response to gravityPlatelet-activating factor receptorHomo sapiens (human)
cellular response to cAMPPlatelet-activating factor receptorHomo sapiens (human)
cellular response to fatty acidPlatelet-activating factor receptorHomo sapiens (human)
response to dexamethasonePlatelet-activating factor receptorHomo sapiens (human)
positive regulation of leukocyte tethering or rollingPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of transcytosisPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of maternal process involved in parturitionPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of gastro-intestinal system smooth muscle contractionPlatelet-activating factor receptorHomo sapiens (human)
cellular response to 2-O-acetyl-1-O-hexadecyl-sn-glycero-3-phosphocholinePlatelet-activating factor receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayPlatelet-activating factor receptorHomo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
response to hypoxiaDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
neutrophil mediated immunityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
germinal center formationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of leukocyte chemotaxisDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
proteolysisDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
membrane protein ectodomain proteolysisDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cell adhesionDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
Notch receptor processingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of cell population proliferationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
response to xenobiotic stimulusDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of T cell chemotaxisDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
protein processingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
signal releaseDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
B cell differentiationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of cell growthDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of cell migrationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
negative regulation of transforming growth factor beta receptor signaling pathwayDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
response to lipopolysaccharideDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of chemokine productionDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of tumor necrosis factor productionDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
regulation of mast cell apoptotic processDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
T cell differentiation in thymusDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cell adhesion mediated by integrinDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
wound healing, spreading of epidermal cellsDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
amyloid precursor protein catabolic processDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of blood vessel endothelial cell migrationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of cyclin-dependent protein serine/threonine kinase activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of epidermal growth factor-activated receptor activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of epidermal growth factor receptor signaling pathwayDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
spleen developmentDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cell motilityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
defense response to Gram-positive bacteriumDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cellular response to high density lipoprotein particle stimulusDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
commissural neuron axon guidanceDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
negative regulation of cold-induced thermogenesisDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of G1/S transition of mitotic cell cycleDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of tumor necrosis factor-mediated signaling pathwayDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
positive regulation of vascular endothelial cell proliferationDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
Notch signaling pathwayDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
G protein-coupled receptor signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
activation of phospholipase C activityG-protein coupled receptor 55Homo sapiens (human)
positive regulation of Rho protein signal transductionG-protein coupled receptor 55Homo sapiens (human)
cannabinoid signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
bone resorptionG-protein coupled receptor 55Homo sapiens (human)
negative regulation of osteoclast differentiationG-protein coupled receptor 55Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeG-protein coupled receptor 55Homo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayG-protein coupled receptor 55Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (63)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
fibroblast growth factor bindingIntegrin beta-3Homo sapiens (human)
C-X3-C chemokine bindingIntegrin beta-3Homo sapiens (human)
insulin-like growth factor I bindingIntegrin beta-3Homo sapiens (human)
neuregulin bindingIntegrin beta-3Homo sapiens (human)
virus receptor activityIntegrin beta-3Homo sapiens (human)
fibronectin bindingIntegrin beta-3Homo sapiens (human)
protease bindingIntegrin beta-3Homo sapiens (human)
protein disulfide isomerase activityIntegrin beta-3Homo sapiens (human)
protein kinase C bindingIntegrin beta-3Homo sapiens (human)
platelet-derived growth factor receptor bindingIntegrin beta-3Homo sapiens (human)
integrin bindingIntegrin beta-3Homo sapiens (human)
protein bindingIntegrin beta-3Homo sapiens (human)
coreceptor activityIntegrin beta-3Homo sapiens (human)
enzyme bindingIntegrin beta-3Homo sapiens (human)
identical protein bindingIntegrin beta-3Homo sapiens (human)
vascular endothelial growth factor receptor 2 bindingIntegrin beta-3Homo sapiens (human)
metal ion bindingIntegrin beta-3Homo sapiens (human)
cell adhesion molecule bindingIntegrin beta-3Homo sapiens (human)
extracellular matrix bindingIntegrin beta-3Homo sapiens (human)
fibrinogen bindingIntegrin beta-3Homo sapiens (human)
protein bindingIntegrin alpha-IIbHomo sapiens (human)
identical protein bindingIntegrin alpha-IIbHomo sapiens (human)
metal ion bindingIntegrin alpha-IIbHomo sapiens (human)
extracellular matrix bindingIntegrin alpha-IIbHomo sapiens (human)
molecular adaptor activityIntegrin alpha-IIbHomo sapiens (human)
fibrinogen bindingIntegrin alpha-IIbHomo sapiens (human)
integrin bindingIntegrin alpha-IIbHomo sapiens (human)
lipopolysaccharide bindingPlatelet-activating factor receptorHomo sapiens (human)
lipopolysaccharide immune receptor activityPlatelet-activating factor receptorHomo sapiens (human)
G protein-coupled receptor activityPlatelet-activating factor receptorHomo sapiens (human)
platelet activating factor receptor activityPlatelet-activating factor receptorHomo sapiens (human)
protein bindingPlatelet-activating factor receptorHomo sapiens (human)
phospholipid bindingPlatelet-activating factor receptorHomo sapiens (human)
mitogen-activated protein kinase bindingPlatelet-activating factor receptorHomo sapiens (human)
G protein-coupled purinergic nucleotide receptor activityPlatelet-activating factor receptorHomo sapiens (human)
endopeptidase activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
metalloendopeptidase activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
Notch bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
interleukin-6 receptor bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
integrin bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
protein bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
peptidase activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
metallopeptidase activityDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
SH3 domain bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cytokine bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
PDZ domain bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
tumor necrosis factor bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
metal ion bindingDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
metalloendopeptidase activity involved in amyloid precursor protein catabolic processDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
G protein-coupled receptor activityG-protein coupled receptor 55Homo sapiens (human)
cannabinoid receptor activityG-protein coupled receptor 55Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (51)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
glutamatergic synapseIntegrin beta-3Homo sapiens (human)
nucleusIntegrin beta-3Homo sapiens (human)
nucleoplasmIntegrin beta-3Homo sapiens (human)
plasma membraneIntegrin beta-3Homo sapiens (human)
cell-cell junctionIntegrin beta-3Homo sapiens (human)
focal adhesionIntegrin beta-3Homo sapiens (human)
external side of plasma membraneIntegrin beta-3Homo sapiens (human)
cell surfaceIntegrin beta-3Homo sapiens (human)
apical plasma membraneIntegrin beta-3Homo sapiens (human)
platelet alpha granule membraneIntegrin beta-3Homo sapiens (human)
lamellipodium membraneIntegrin beta-3Homo sapiens (human)
filopodium membraneIntegrin beta-3Homo sapiens (human)
microvillus membraneIntegrin beta-3Homo sapiens (human)
ruffle membraneIntegrin beta-3Homo sapiens (human)
integrin alphav-beta3 complexIntegrin beta-3Homo sapiens (human)
melanosomeIntegrin beta-3Homo sapiens (human)
synapseIntegrin beta-3Homo sapiens (human)
postsynaptic membraneIntegrin beta-3Homo sapiens (human)
extracellular exosomeIntegrin beta-3Homo sapiens (human)
integrin alphaIIb-beta3 complexIntegrin beta-3Homo sapiens (human)
glycinergic synapseIntegrin beta-3Homo sapiens (human)
integrin complexIntegrin beta-3Homo sapiens (human)
protein-containing complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-PKCalpha complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-IGF-1-IGF1R complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-HMGB1 complexIntegrin beta-3Homo sapiens (human)
receptor complexIntegrin beta-3Homo sapiens (human)
alphav-beta3 integrin-vitronectin complexIntegrin beta-3Homo sapiens (human)
alpha9-beta1 integrin-ADAM8 complexIntegrin beta-3Homo sapiens (human)
focal adhesionIntegrin beta-3Homo sapiens (human)
cell surfaceIntegrin beta-3Homo sapiens (human)
synapseIntegrin beta-3Homo sapiens (human)
plasma membraneIntegrin alpha-IIbHomo sapiens (human)
focal adhesionIntegrin alpha-IIbHomo sapiens (human)
cell surfaceIntegrin alpha-IIbHomo sapiens (human)
platelet alpha granule membraneIntegrin alpha-IIbHomo sapiens (human)
extracellular exosomeIntegrin alpha-IIbHomo sapiens (human)
integrin alphaIIb-beta3 complexIntegrin alpha-IIbHomo sapiens (human)
blood microparticleIntegrin alpha-IIbHomo sapiens (human)
integrin complexIntegrin alpha-IIbHomo sapiens (human)
external side of plasma membraneIntegrin alpha-IIbHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membranePlatelet-activating factor receptorHomo sapiens (human)
membranePlatelet-activating factor receptorHomo sapiens (human)
secretory granule membranePlatelet-activating factor receptorHomo sapiens (human)
tertiary granule membranePlatelet-activating factor receptorHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
cell-cell junctionDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
focal adhesionDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
ruffle membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
Golgi membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cytoplasmDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
endoplasmic reticulum lumenDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cytosolDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
plasma membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
cell surfaceDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
actin cytoskeletonDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
apical plasma membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
membrane raftDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
plasma membraneDisintegrin and metalloproteinase domain-containing protein 17Homo sapiens (human)
plasma membraneG-protein coupled receptor 55Homo sapiens (human)
plasma membraneG-protein coupled receptor 55Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (24)

Assay IDTitleYearJournalArticle
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID202664The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 12 hours at a concentration of 4 uM in the G2/M phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID81462Cytotoxicity in HL-60 (human leukemia) cell line.1999Journal of medicinal chemistry, Feb-11, Volume: 42, Issue:3
Design of antineoplastic agents based on the "2-phenylnaphthalene-type" structural pattern. 4. Synthesis and biological activity of 2-chloro-3-(substituted phenoxy)-1, 4-naphthoquinones and related 5,8-dihydroxy-1,4-naphthoquinones.
AID200621Cytotoxicity in SCLC (human lung carcinoma) cell line.1999Journal of medicinal chemistry, Feb-11, Volume: 42, Issue:3
Design of antineoplastic agents based on the "2-phenylnaphthalene-type" structural pattern. 4. Synthesis and biological activity of 2-chloro-3-(substituted phenoxy)-1, 4-naphthoquinones and related 5,8-dihydroxy-1,4-naphthoquinones.
AID202670The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 24 hours at a concentration of 4 uM in the G1 phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202671The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 6 hours at a concentration of 4 uM in the G1 phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202661The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 0 hr at a concentration of 4 uM in the G1 phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202668The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 0 hr at a concentration of 4 uM in the S phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202667The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 6 hours at a concentration of 4 uM in the S phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202669The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 12 hours at a concentration of 4 uM in the S phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202672The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 6 hours at a concentration of 4 uM in the G2/M phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202663The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 12 hours at a concentration of 4 uM in the G1 phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID144662Complete inhibition of cell growth of 60-human tumor cell line detected by National Cancer Institute; not determined1999Journal of medicinal chemistry, Feb-11, Volume: 42, Issue:3
Design of antineoplastic agents based on the "2-phenylnaphthalene-type" structural pattern. 4. Synthesis and biological activity of 2-chloro-3-(substituted phenoxy)-1, 4-naphthoquinones and related 5,8-dihydroxy-1,4-naphthoquinones.
AID202662The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 0 hr at a concentration of 4 uM in the G2/M phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202665The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 24 hours at a concentration of 4 uM in the G2/M phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID202666The compound was evaluated for the percent cell cycle fraction when human hepatoma SK hep-1 cells were treated with the compound for 24 hours at a concentration of 4 uM in the S phase of cell cycle1998Bioorganic & medicinal chemistry letters, Sep-22, Volume: 8, Issue:18
Naphthoquinone analogs as inactivators of cdc25 phosphatase.
AID1347149Furin counterscreen 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.
AID1347161Confirmatory screen NINDS Rhodamine 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.
AID1347169Tertiary RLuc qRT-PCR qHTS assay 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.
AID1347157Confirmatory screen GU Rhodamine qHTS for Zika virus inhibitors qHTS2020Proceedings 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.
AID1525077Inverse agonist activity at GPR55 in human MDA-MB-231 cells assessed as reduction in cell viability incubated for 24 hrs by MTT assay2019ACS medicinal chemistry letters, Apr-11, Volume: 10, Issue:4
Discovery of 1,4-Naphthoquinones as a New Class of Antiproliferative Agents Targeting GPR55.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (103)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (0.97)18.7374
1990's41 (39.81)18.2507
2000's26 (25.24)29.6817
2010's24 (23.30)24.3611
2020's11 (10.68)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 34.82

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

MetricThis Compound (vs All)
Research Demand Index34.82 (24.57)
Research Supply Index2.20 (2.92)
Research Growth Index4.59 (4.65)
Search Engine Demand Index44.85 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (34.82)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials27 (26.73%)5.53%
Trials0 (0.00%)5.53%
Reviews9 (8.91%)6.00%
Reviews0 (0.00%)6.00%
Case Studies15 (14.85%)4.05%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Observational0 (0.00%)0.25%
Other50 (49.50%)84.16%
Other8 (100.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (349)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized Controlled Trial of Etoposide in the First-line Treatment of Adult Epstein-barr Virus Associated Hemophagocytic Lymphohistiocytosis [NCT03742115]Phase 390 participants (Anticipated)Interventional2018-12-01Not yet recruiting
A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC# 731636, IND#) in Children With CD30+ Recurrent Anaplastic Large Cell Lymphoma [NCT00354107]Phase 1/Phase 25 participants (Actual)Interventional2007-01-31Terminated
A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma [NCT00072384]Phase 330 participants (Actual)Interventional2007-04-16Completed
A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors [NCT00053352]Phase 3302 participants (Actual)Interventional2003-11-03Completed
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease [NCT00302003]Phase 3287 participants (Actual)Interventional2006-02-28Completed
Risk-Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study [NCT00026208]Phase 276 participants (Actual)Interventional2001-06-30Completed
An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of LBL-024 Combined With Etoposide and Platinum in the First-line Treatment of Patients With Advanced Neuroendocrine Carcinoma (NEC) [NCT06157827]Phase 1/Phase 268 participants (Anticipated)Interventional2023-12-05Not yet recruiting
Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC [NCT04092283]Phase 3660 participants (Anticipated)Interventional2020-04-29Active, not recruiting
Randomized Phase II Clinical Trial of Cisplatin/Carboplatin and Etoposide (CE) Alone or in Combination With Nivolumab as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ED-SCLC) [NCT03382561]Phase 2160 participants (Actual)Interventional2018-05-02Active, not recruiting
A Feasibility Study of Vorinostat (SAHA) Combined With Isotretinoin and Chemotherapy in Infants With Embryonal Tumors of the Central Nervous System [NCT00867178]Phase 133 participants (Actual)Interventional2009-02-25Completed
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination With Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer [NCT01642251]Phase 1/Phase 2156 participants (Actual)Interventional2012-09-28Completed
A Phase I Study of Azacitidine Combined With Mitoxantrone and Etoposide (A-NOVE) Chemotherapy for Patients' Age ≥ 60 With Poor Prognosis Acute Myeloid Leukemia (AML) [NCT01260714]Phase 113 participants (Actual)Interventional2010-12-31Terminated(stopped due to Inadequate accrual rate)
Prospective, Multi-center Phase I/II Trial of Lenalidomide and Dose-Adjusted EPOCH-R in MYC-Associated B-Cell Lymphomas [NCT02213913]Phase 1/Phase 246 participants (Anticipated)Interventional2014-07-29Active, not recruiting
Hematopoietic Stem Cell Transplantation Using Bone Marrow Or Peripheral Blood Stem Cells From Matched, Unrelated, Volunteer Donors [NCT00054327]Phase 234 participants (Actual)Interventional2000-11-30Completed
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy [NCT01871766]Phase 298 participants (Actual)Interventional2013-12-04Active, not recruiting
A Phase I Study of AC220 for Children With Relapsed or Refractory ALL or AML [NCT01411267]Phase 124 participants (Actual)Interventional2011-09-01Completed
Apatinib+Ifosfamide and Etoposide (IE) Versus IE Alone for Relapsed or Refractory Osteosarcoma: a Real-world Study in Two Centers in China [NCT04690231]79 participants (Actual)Interventional2020-12-01Completed
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT03023046]Phase 254 participants (Actual)Interventional2017-02-23Completed
A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy [NCT03781869]Phase 2116 participants (Anticipated)Interventional2018-12-31Not yet recruiting
Ocular Conservative Treatment for Retinoblastoma: Efficacy of the New Management Strategies and Visual Outcome - RETINO 2018 [NCT04681417]Phase 2/Phase 3225 participants (Anticipated)Interventional2021-03-25Recruiting
A Phase 1 Study of MLN9708 in Combination With MEC (Mitoxantrone, Etoposide, and Intermediate-Dose Cytarabine) for Relapsed/ Refractory Acute Myelogenous Leukemia (AML) [NCT02070458]Phase 130 participants (Actual)Interventional2014-10-08Completed
A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors [NCT02372409]Phase 212 participants (Anticipated)Interventional2015-08-14Recruiting
A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse [NCT04546399]Phase 2550 participants (Anticipated)Interventional2020-12-04Suspended(stopped due to Other - FDA Partial Clinical Hold)
Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma [NCT02137928]Phase 350 participants (Anticipated)Interventional2006-01-31Recruiting
Phase I Study of the Combination of Midostaurin, Bortezomib, and Chemotherapy in Relapsed/Refractory Acute Myeloid Leukemia [NCT01174888]Phase 134 participants (Actual)Interventional2010-08-31Completed
A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung Cancer [NCT01563601]Phase 30 participants (Actual)Interventional2012-08-31Withdrawn(stopped due to Business Decision)
A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer [NCT00079040]Phase 265 participants (Actual)Interventional2006-01-31Completed
A Phase I Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Escalating Doses of Inotuzumab Ozogamicin (DA-EPOCH-InO) in Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia [NCT03991884]Phase 124 participants (Actual)Interventional2019-09-24Completed
Phase II Trial of Standard Platinum Doublet Chemotherapy + Various Proton Beam Therapy (PBT) Doses in Order to Determine the Optimal Dose of PBT for Unresectable Stage 2/3 Non-Small Cell Lung Cancer [NCT03132532]Phase 218 participants (Actual)Interventional2017-07-31Active, not recruiting
A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen [NCT00074165]Phase 217 participants (Actual)Interventional2003-01-31Terminated(stopped due to Lack of accrual)
A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide [NCT00057837]Phase 2140 participants (Actual)Interventional2004-07-14Completed
A Phase II Trial Combining Hypofractionated Radiation Boost With Conventionally-Fractionated Chemoradiation in Locally Advanced Non-small Cell Lung Cancer Not Suitable for Surgery [NCT02262325]Phase 221 participants (Actual)Interventional2015-06-08Active, not recruiting
Romidepsin in Combination With CHOEP as First Line Treatment Before Hematopoietic Stem Cell Transplantation in Young Patients With Nodal Peripheral T-cell Lymphomas: a Phase I-II Study [NCT02223208]Phase 1/Phase 289 participants (Actual)Interventional2014-09-30Active, not recruiting
A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations [NCT04293562]Phase 31,400 participants (Anticipated)Interventional2020-07-21Recruiting
Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years [NCT01096368]Phase 3479 participants (Actual)Interventional2010-05-07Active, not recruiting
Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948]Phase 297 participants (Actual)Interventional2009-09-01Active, not recruiting
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer [NCT00334815]Phase 229 participants (Actual)Interventional2006-06-15Active, not recruiting
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer. [NCT00526396]Phase 3160 participants (Anticipated)Interventional2007-09-30Active, not recruiting
The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years [NCT00369317]Phase 3205 participants (Actual)Interventional2007-03-31Completed
Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas [NCT03188198]Phase 260 participants (Anticipated)Interventional2016-06-01Recruiting
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
Combination Chemotherapy With or Without Maintenance Sunitinib Malate (NSC 736511) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase IB/Randomized Phase II Study [NCT00453154]Phase 1/Phase 2156 participants (Actual)Interventional2007-03-15Completed
A Phase I-II Trial of DA-EPOCH-R Plus Ixazomib as Frontline Therapy for Patients With MYC-aberrant Lymphoid Malignancies: The DACIPHOR Regimen [NCT02481310]Phase 1/Phase 238 participants (Actual)Interventional2015-10-28Active, not recruiting
A Randomized Phase II Trial of Etoposide Plus Lobaplatin Versus Etoposide Plus Cisplatin in Combination With Concurrent Thoracic Radiotherapy for Patients With Limited Small-cell Lung Cancer [NCT03613597]Phase 2118 participants (Anticipated)Interventional2018-06-01Recruiting
A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) With Oral Etoposide Administration in Children With Progressive Diffuse Midline Glioma (DMG) [NCT05762419]Phase 110 participants (Anticipated)Interventional2023-03-31Recruiting
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-Selection Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 in Patients With Intermittent Claudication [NCT00117650]Phase 2289 participants (Actual)Interventional2005-02-28Completed
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults [NCT02003222]Phase 3488 participants (Actual)Interventional2014-05-19Active, not recruiting
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
Phase I-II Study of Escalating Doses of Large Field Image-Guided Intensity Modulated Radiation Therapy (IMRT) Using Helical Tomotherapy in Combination With Etoposide (VP16) and Cytoxan as a Preparative Regimen for Allogeneic Hematopoietic Stem Cell (HSC) [NCT00576979]Phase 1/Phase 251 participants (Actual)Interventional2008-03-04Active, not recruiting
Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors [NCT00379340]Phase 3395 participants (Actual)Interventional2007-02-26Active, not recruiting
Phase I/II Study of VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Relapsed Indolent Non-Hodgkin's Lymphoma, Transformed or Mantle Cell Lymphoma [NCT00571493]Phase 1/Phase 242 participants (Actual)Interventional2006-04-14Completed
A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL) [NCT01979536]Phase 2137 participants (Actual)Interventional2013-11-13Active, not recruiting
A Phase II Trial of Sequential Chemotherapy, Imatinib Mesylate (Gleevec, STI571) (NSC # 716051), and Transplantation for Adults With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by the CALGB and SWOG [NCT00039377]Phase 258 participants (Actual)Interventional2002-04-30Completed
A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) [NCT02112916]Phase 3847 participants (Actual)Interventional2014-10-04Active, not recruiting
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) [NCT04663347]Phase 1/Phase 2662 participants (Anticipated)Interventional2020-11-03Recruiting
Phase I and Dose-Expansion Study of Ibrutinib and R-da-EPOCH for Front Line Treatment of AIDS-Related Lymphomas [NCT03220022]Phase 154 participants (Anticipated)Interventional2018-03-16Recruiting
Intravitreal Melphalan for Intraocular Retinoblastoma [NCT05504291]Phase 228 participants (Anticipated)Interventional2022-11-04Recruiting
A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor [NCT04684368]Phase 2160 participants (Anticipated)Interventional2021-07-13Recruiting
Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT) [NCT04322318]Phase 2221 participants (Anticipated)Interventional2020-10-19Recruiting
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) [NCT03533582]Phase 2/Phase 3537 participants (Anticipated)Interventional2018-05-24Recruiting
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors [NCT03067181]Phase 32,059 participants (Anticipated)Interventional2017-05-25Recruiting
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147]Phase 3475 participants (Anticipated)Interventional2017-08-08Recruiting
Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) [NCT02101853]Phase 3669 participants (Actual)Interventional2014-12-17Active, not recruiting
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy With Rituximab in HIV-Related B-Cell Non-Hodgkin's Lymphoma [NCT01193842]Phase 1/Phase 2107 participants (Actual)Interventional2010-10-06Completed
A Phase II Study for the Treatment of Non-metastatic Nodular Desmoplastic Medulloblastoma in Children Less Than 4 Years of Age [NCT02017964]Phase 226 participants (Actual)Interventional2013-12-24Completed
A Phase I Dose Finding Study of the Pan-DAC Inhibitor Panobinostat (LBH589) in Combination With Etoposide and Cisplatin in the First Line Treatment of Extensive-Stage Small Cell Lung Cancer - An ICORG In-House Study [NCT01160731]Phase 10 participants (Actual)Interventional2009-11-30Withdrawn
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259]Phase 31,734 participants (Actual)Interventional2002-09-30Completed
Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 (IL-2) Immunotherapy [NCT00003875]Phase 230 participants (Actual)Interventional1998-10-13Completed
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL) [NCT03126916]Phase 3724 participants (Anticipated)Interventional2018-05-14Active, not recruiting
A Phase I Study of Bortezomib in Combination With MEC (Mitoxantrone, Etoposide, and Intermediate-Dose Cytarabine) for Relapsed/ Refractory Acute Myelogenous Leukemia (AML) [NCT01127009]Phase 13 participants (Actual)Interventional2010-07-31Completed
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A [NCT01858922]Phase 240 participants (Actual)Interventional2012-12-19Active, not recruiting
Prospective Randomized Comparison of ABVD Versus BEACOPP Chemotherapy With or Without Radiotherapy for Advanced Stage or Unfavorable Hodgkin's Lymphoma (HL) [NCT01251107]Phase 3331 participants (Actual)Interventional2000-03-31Completed
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220]Phase 3166 participants (Actual)Interventional2009-12-07Completed
NASSIST (Neoadjuvant Chemoradiation +/- Immunotherapy Before Surgery for Superior Sulcus Tumors): A Randomized Phase II Trial of Trimodality +/- Atezolizumab in Resectable Superior Sulcus Non-Small Cell Lung Cancer [NCT04989283]Phase 20 participants (Actual)Interventional2021-09-09Withdrawn(stopped due to Due to no accrual)
A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Canc [NCT00977561]Phase 29 participants (Actual)Interventional2010-04-30Terminated(stopped due to See termination reason in detailed description.)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Etoposide With or Without Tislelizumab (BGB-A317) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer [NCT04005716]Phase 3457 participants (Actual)Interventional2019-07-22Active, not recruiting
A Phase 1 Study of Lenalidomide in Combination With EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL) [NCT04301076]Phase 130 participants (Anticipated)Interventional2021-08-31Recruiting
Phase I Study to Evaluate Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a CD19-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Receptor and a Truncated EGFR Following Lymphodepleting Chemotherapy in Adult P [NCT02153580]Phase 137 participants (Actual)Interventional2014-09-24Active, not recruiting
Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer [NCT02208583]150 participants (Anticipated)Interventional2014-06-30Recruiting
Phase I Trial of Cisplatin and Etoposide Plus BKM120 in Advanced Solid Tumors, With an Emphasis on Small Cell Lung Cancer [NCT02194049]Phase 13 participants (Actual)Interventional2014-07-31Completed
Surgery or Radiotherapy After PD-L1 Inhibitor (TQB-2450) and Chemotherapy Induction Therapy in Patients With Limited-stage Small-cell Lung Cancer [NCT04539977]Phase 240 participants (Anticipated)Interventional2020-09-01Recruiting
A Phase I/II Trial of PARP Inhibition, Radiation, and Immunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) - PRIO Trial [NCT04728230]Phase 1/Phase 263 participants (Anticipated)Interventional2021-01-05Recruiting
Phase II Trial of Pembrolizumab in Combination With ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma [NCT03077828]Phase 243 participants (Actual)Interventional2017-04-21Active, not recruiting
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11) [NCT05008224]Phase 2146 participants (Actual)Interventional2021-10-07Active, not recruiting
A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD [NCT01371981]Phase 31,645 participants (Actual)Interventional2011-06-20Active, 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 II Study of Nivolumab in Combination With DA-REPOCH Followed by Short Course Nivolumab Consolidation in Patients With Aggressive B-Cell Non-Hodgkin's Lymphoma [NCT03749018]Phase 230 participants (Anticipated)Interventional2019-01-02Active, not recruiting
CASPIAN-RT Trial: Hypofractionated Consolidative Radiation Therapy After Durvalumab (MEDI4736) Plus Platinum-Based Chemotherapy in Extensive Stage Small Cell Lung Cancer [NCT05161533]Phase 20 participants (Actual)Interventional2023-10-19Withdrawn(stopped due to Closed per SRC Low Accrual Policy. Study closed prior to any participants enrolled.)
A Phase II Study of Platinum and Etoposide Chemotherapy, Durvalumab With Thoracic Radiotherapy in the First Line Treatment of Patients With Extensive-stage Small-cell Lung Cancer [NCT05796089]Phase 235 participants (Anticipated)Interventional2022-01-01Recruiting
A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin Plus Asparaginase (DA-EPOCH-A) for Adults With Acute Lymphoblastic Leukemia/Lymphoma [NCT02538926]Phase 20 participants (Actual)Interventional2018-07-01Withdrawn(stopped due to Drugs unavailable)
Ex-Vivo Expanded Allogeneic NK Cells for the Treatment of Solid Tumors of Pediatric Origin in Children and Young Adults [NCT03420963]Phase 138 participants (Anticipated)Interventional2018-08-31Recruiting
Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00549848]Phase 3600 participants (Actual)Interventional2007-10-29Completed
Phase I/ II Trial of Carboplatin and Etoposide Plus LBH589 for Previously Untreated Extensive Stage Small Cell Lung Cancer [NCT00958022]Phase 17 participants (Actual)Interventional2009-09-30Terminated(stopped due to Based on the tolerabilty challenges of the combination)
Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents [NCT00749723]Phase 2/Phase 3174 participants (Actual)Interventional2006-02-01Completed
A Feasibility Pilot and Phase II Study Of Chemoimmunotherapy With Epratuzumab (IND #12034) for Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia (ALL) [NCT00098839]Phase 1/Phase 2134 participants (Actual)Interventional2005-02-28Completed
A Phase II Single Arm Study of the Use of CODOX-M/IVAC With Rituximab (R-CODOX-M/IVAC) in the Treatment of Patients With Diffuse Large B-Cell Lymphoma (International Prognostic Index High or High-Intermediate Risk) [NCT00974792]Phase 2150 participants (Anticipated)Interventional2006-01-31Recruiting
A Pilot Study To Determine The Toxicity Of The Addition Of Rituximab To The Induction And Consolidation Phases And The Addition Of Rasburicase To The Reduction Phase In Children With Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated With LMB/FAB T [NCT00057811]Phase 297 participants (Actual)Interventional2004-06-30Completed
A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma [NCT00073918]Phase 2111 participants (Actual)Interventional1999-02-28Completed
Pharmacokinetics and Pharmacogenetics of Anticancer Drugs in Infants and Young Children [NCT00897871]60 participants (Anticipated)Observational2007-02-28Recruiting
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage Small Cell Lung Cancer [NCT00887159]Phase 2168 participants (Actual)Interventional2009-07-16Completed
A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT00873093]Phase 2148 participants (Actual)Interventional2009-03-31Completed
DFCI ALL Adult Consortium Protocol: Adult ALL Trial [NCT01005758]Phase 2180 participants (Anticipated)Interventional2009-01-31Not yet recruiting
A Phase I Study of Durvalumab (MEDI4736) Plus Tremelimumab in Combination With Platinum-based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer and Performance Status 2 [NCT03963414]Phase 11 participants (Actual)Interventional2020-09-25Terminated(stopped due to low accrual)
Phase II Study of Total Marrow and Lymphoid Irradiation (TMLI) Given in Combination With Cyclophosphamide and Etoposide as Conditioning for Allogeneic (HSCT) in Patients With High-Risk Acute Lymphocytic or Myelogenous Leukemia [NCT02094794]Phase 287 participants (Anticipated)Interventional2014-05-12Recruiting
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma [NCT05675410]Phase 31,875 participants (Anticipated)Interventional2023-05-11Recruiting
Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer. [NCT01064466]Phase 2/Phase 3600 participants (Anticipated)Interventional2017-01-31Active, not recruiting
A Phase II Study of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) Alternating With Pralatrexate (P) as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin Lymphoma [NCT01336933]Phase 234 participants (Actual)Interventional2011-07-06Completed
Phase II Clinical Trial of Patients With High-Grade Glioma Treated With Intra-Arterial Carboplatin-Based Chemotherapy, Randomized to Treatment With or Without Delayed Intravenous Sodium Thiosulfate as a Potential Chemoprotectant Against Severe Thrombocyto [NCT00075387]Phase 248 participants (Actual)Interventional2003-03-07Active, not recruiting
Phase II Study of Maintenance Therapy With Decitabine (NSC #127716) Following Standard Induction and Cytogenetic Risk-Adapted Intensification in Previously Untreated Patients With AML < 60 Years [NCT00416598]Phase 2546 participants (Actual)Interventional2006-11-15Completed
Durvalumab+ Anlotinib + Standard Chemotherapy in First-line Treatment of Extensive Small-cell Lung Cancer: a Single-arm, Single-center, Phase II Clinical Study [NCT04660097]Phase 2120 participants (Anticipated)Interventional2021-05-20Recruiting
A Phase 1/2 Study of the Bromodomain Inhibitor Molibresib in Combination With Etoposide/Platinum in Patients With NUT Carcinoma [NCT04116359]Phase 1/Phase 20 participants (Actual)Interventional2020-09-18Withdrawn(stopped due to Other - Protocol moved to Disapproved)
Sirolimus and Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation [NCT01220297]Phase 23 participants (Actual)Interventional2006-08-31Terminated(stopped due to Low accrual)
Phase 2 Trial of PEG-ASP Combined With Etoposide and Gemcitabine (PEG) as First-line Chemotherapy to Treat NK/T-cell Lymphoma [NCT02705508]Phase 235 participants (Anticipated)Interventional2016-02-29Recruiting
A Phase II Study of Rituximab, Lenalidomide, and Ibrutinib Combined With Chemotherapy for Patients With High Risk Diffuse Large B-Cell Lymphoma [NCT02636322]Phase 260 participants (Actual)Interventional2016-03-29Completed
PEPI: Protracted Etoposide in a Phase II Upfront Window for Induction Therapy for High Risk Neuroblastoma [NCT00578864]Phase 213 participants (Actual)Interventional2007-03-31Completed
Phase Ib Trial of Pembrolizumab (MK-3475) With Platinum-Based Chemotherapy in Small Cell/Neuroendocrine Cancers of Urothelium and Prostate [NCT03582475]Phase 115 participants (Actual)Interventional2018-12-20Completed
A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma [NCT00554788]Phase 360 participants (Actual)Interventional2008-02-04Active, not recruiting
Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome [NCT02521493]Phase 3312 participants (Anticipated)Interventional2015-12-23Active, not recruiting
Randomized Phase 3 Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008) to Multiagent Chemotherapy for Patients With Newly Diagnosed Metastatic Ewing Sarcoma [NCT02306161]Phase 3312 participants (Actual)Interventional2014-12-12Active, not recruiting
Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma [NCT02176967]Phase 3621 participants (Anticipated)Interventional2014-08-08Active, not recruiting
A Phase 1 Study of Azacitidine in Combination With MEC (Mitoxantrone, Etoposide, Cytarabine) in Relapsed and Refractory Acute Myeloid Leukemia [NCT01249430]Phase 124 participants (Actual)Interventional2011-01-20Completed
Protocol for the Study and Treatment of Patients With Intraocular Retinoblastoma [NCT00186888]Phase 3107 participants (Actual)Interventional2005-04-07Active, not recruiting
A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26) [NCT00689845]120 participants (Anticipated)Interventional2007-06-30Recruiting
Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias [NCT00882076]Phase 122 participants (Actual)Interventional2009-03-31Terminated(stopped due to study closed prematurely)
Mobilization of Autologous Peripheral Blood Stem Cells (PBSC) in CD20+ Lymphoma Patients Using RICE, G-CSF (Granulocyte-Colony Stimulating Factor), and Plerixafor [NCT01097057]Phase 220 participants (Actual)Interventional2010-11-09Completed
A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT [NCT01356290]Phase 2100 participants (Anticipated)Interventional2014-04-30Recruiting
A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors [NCT00618813]35 participants (Actual)Interventional2008-03-31Completed
Conservative Treatments of Retinoblastoma [NCT02866136]Phase 2133 participants (Anticipated)Interventional2012-02-29Active, not recruiting
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
A Phase 2 Study of Polatuzumab Vedotin With Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma [NCT04665765]Phase 241 participants (Actual)Interventional2021-01-18Active, not recruiting
Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer [NCT02402920]Phase 183 participants (Actual)Interventional2015-07-22Active, not recruiting
A Phase I Dose-Intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer [NCT01411098]Phase 16 participants (Actual)Interventional2011-10-31Terminated(stopped due to Low accrual)
Phase II/III Trial of Simmtecan and 5-FU/LV Regimen (FOLFSIM) Plus Teripalimab Versus EP/EC in Advanced or Metastatic Neuroendocrine Carcinoma [NCT03992911]Phase 2/Phase 3336 participants (Anticipated)Interventional2019-06-19Recruiting
Phase II Study of Dose-Adjusted EPOCH+/-Rituximab in Adults With Untreated Burkitt Lymphoma, c-MYC Positive Diffuse Large B-Cell Lymphoma and Plasmablastic Lymphoma [NCT01092182]Phase 2194 participants (Actual)Interventional2010-03-25Completed
A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia [NCT00666588]Phase 252 participants (Actual)Interventional2008-04-30Completed
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma [NCT00567567]Phase 3665 participants (Actual)Interventional2007-11-05Completed
A Phase I Study of M3814 in Combination With MEC in Patients With Relapsed or Refractory Acute Myeloid Leukemia [NCT03983824]Phase 148 participants (Anticipated)Interventional2020-05-05Recruiting
A Randomized Phase 3 Study of Brentuximab Vedotin (SGN-35) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Young Adults [NCT02166463]Phase 3600 participants (Actual)Interventional2015-03-19Active, not recruiting
Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109]Phase 2/Phase 363 participants (Actual)Interventional2008-07-14Completed
Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC [NCT01993810]Phase 3330 participants (Actual)Interventional2014-02-03Active, not recruiting
UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients [NCT00574080]Phase 320 participants (Actual)Interventional2006-07-31Terminated(stopped due to low accrual)
A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer [NCT00017251]Phase 112 participants (Actual)Interventional2001-04-30Completed
A Pilot Study Of Tandem High Dose Chemotherapy With Stem Cell Rescue Following Induction Therapy In Children With High Risk Neuroblastoma [NCT00017368]Phase 242 participants (Actual)Interventional2001-04-30Completed
Bortezomib (Velcade®) and Reduced-Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoid Malignancies [NCT00439556]Phase 240 participants (Actual)Interventional2007-02-13Completed
A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma [NCT00392990]Phase 225 participants (Actual)Interventional2007-02-06Completed
High-dose Chemotherapy and Autologous Stem Cell Transplant or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma - Randomized Phase III Trial [NCT02531841]Phase 3250 participants (Anticipated)Interventional2014-07-31Recruiting
A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma [NCT02561273]Phase 1/Phase 254 participants (Actual)Interventional2015-09-28Completed
Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies [NCT00381680]Phase 3275 participants (Actual)Interventional2007-03-31Completed
A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy [NCT00335738]Phase 3331 participants (Actual)Interventional2005-12-31Completed
A Phase II Study of Tirapazamine (NSC-130181)/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited Stage Small Cell Lung Cancer [NCT00066742]Phase 272 participants (Actual)Interventional2003-09-30Completed
A Phase I Trial of Bendamustine in Combination With Clofarabine and Etoposide in Pediatric Patients With Relapsed or Refractory Hematologic Malignancies [NCT01900509]Phase 116 participants (Actual)Interventional2013-08-31Completed
A Phase I Study of Lenalidomide Therapy Prior to Re-induction Chemotherapy With Mitoxantrone, Etoposide, and Cytarabine (MEC) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML) [NCT01904643]Phase 117 participants (Actual)Interventional2014-02-28Terminated(stopped due to Accrual factor)
Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors [NCT00238173]Phase 12 participants (Actual)Interventional2004-12-31Terminated(stopped due to OHSU IRB closed study to further enrollment 2/17/2006)
Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma [NCT01947062]Phase 360 participants (Anticipated)Interventional2013-10-31Not yet recruiting
Personalized Monitoring of Intravenous Busulfan Dosing for Patients With Lymphoma Undergoing Autologous Stem Cell Transplantation. [NCT01959477]Early Phase 133 participants (Actual)Interventional2014-03-31Completed
A Randomized Registry Trial of Adjuvant Mitotane vs. Mitotane With Cisplatin/Etoposide After Primary Surgical Resection of Localized Adrenocortical Carcinoma With High Risk of Recurrence (ADIUVO-2 Trial) [NCT03583710]Phase 3240 participants (Anticipated)Interventional2018-08-20Recruiting
Pilot Study of Crenolanib Combined With Standard Salvage Chmetherapy in Subjects With Relapsed/Refractory Acute Myeloid Leukemia [NCT02626338]Phase 1/Phase 216 participants (Actual)Interventional2016-02-29Completed
An International Clinical Program for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Ependymoma [NCT02265770]Phase 2/Phase 3536 participants (Anticipated)Interventional2015-06-02Recruiting
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173]Phase 245 participants (Anticipated)Interventional2001-10-31Terminated
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
"Phase I Study of Yttrium-90 Labeled Anti-CD25 (a-Tac) Monoclonal Antibody Plus BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma, the a-Tac BEAM Regimen" [NCT01476839]Phase 125 participants (Actual)Interventional2012-11-09Active, not recruiting
A Phase I Study of Pomalidomide Given at the Time of Lymphocyte Recovery Following Induction Timed Sequential Chemotherapy With Cytarabine, Daunorubicin and Etoposide (AcDVP16) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) and High-Risk MD [NCT02029950]Phase 150 participants (Actual)Interventional2013-12-16Completed
Phase III Randomized Study of Induction Chemotherapy With or Without MDR-Modulation With PSC-833 (NSC # 648265, IND # 41121) Followed by Cytogenetic Risk-Adapted Intensification Therapy Followed by Immunotherapy With rIL-2 (NSC # 373364, IND # 1969) vs. O [NCT00006363]Phase 3720 participants (Actual)Interventional2000-11-30Completed
Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis [NCT04551131]Phase 1/Phase 262 participants (Anticipated)Interventional2021-07-13Recruiting
A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer. [NCT04691063]Phase 3486 participants (Anticipated)Interventional2021-01-22Enrolling by invitation
A Pilot Study of Safety and Feasibility of Stem Cell Therapy for Aids Lymphoma Using Stem Cells Treated With a Lentivirus Vector-Encoding Multiple Anti-HIV RNAs [NCT00569985]Phase 15 participants (Actual)Interventional2007-06-30Completed
A Randomized Study of Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation Therapy in Stage III Unresectable NSCLC [NCT00191139]Phase 264 participants (Actual)Interventional2003-03-31Completed
Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma [NCT01132807]Phase 2164 participants (Actual)Interventional2010-05-31Completed
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer [NCT05624996]Phase 3474 participants (Anticipated)Interventional2023-05-10Recruiting
A Phase II Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia [NCT03164057]Phase 2206 participants (Actual)Interventional2017-06-15Active, not recruiting
Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT03136146]Phase 242 participants (Anticipated)Interventional2017-08-09Recruiting
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
Phase II Study of the Dose Adjusted EPOCH Regimen in Combination With Ofatumumab/Rituximab as Therapy for Patients With Newly Diagnosed or Relapsed/Refractory Burkitt Leukemia or Relapsed/Refractory Acute Lymphoblastic Leukemia [NCT02199184]Phase 26 participants (Actual)Interventional2015-01-14Completed
Cyclosporine Modulation of Drug Resistance in Combination With Pravastatin, Mitoxantrone, and Etoposide for Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML): A Phase 1/2 Study [NCT01342887]Phase 1/Phase 26 participants (Actual)Interventional2011-04-30Terminated
A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer [NCT00717938]Phase 3390 participants (Actual)Interventional2008-06-30Completed
Phase I Dose Escalation of Vandetanib (Zactima, ZD6474) in Combination With Etoposide for Malignant Gliomas [NCT00613223]Phase 149 participants (Actual)Interventional2008-02-29Completed
A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer [NCT00658580]Phase 3361 participants (Actual)Interventional2000-04-30Completed
Autologous and Allogeneic Transplantation for T-Cell Lymphoma: Impact of Campath -1H and Soluble CD52 [NCT00505921]Phase 227 participants (Actual)Interventional2003-03-31Terminated(stopped due to Slow Accrual.)
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
Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients [NCT01416961]Phase 10 participants (Actual)Interventional2011-08-31Withdrawn(stopped due to Neutron therapy has become unavailable)
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia [NCT01423500]Phase 3405 participants (Anticipated)Interventional2007-01-31Active, not recruiting
Allogeneic Stem Cell Transplantation in Children and Adolescents With Acute Lymphoblastic Leukaemia [NCT01423747]Phase 3400 participants (Anticipated)Interventional2003-07-31Active, not recruiting
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors [NCT01424839]Phase 4400 participants (Anticipated)Interventional2011-10-31Recruiting
A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE) [NCT05468489]Phase 3200 participants (Anticipated)Interventional2022-11-18Recruiting
A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma [NCT00086944]Phase 1/Phase 225 participants (Actual)Interventional2004-05-31Completed
NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma [NCT00410631]Phase 3642 participants (Anticipated)Interventional2004-10-31Recruiting
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.)
Risk-Adapted Therapy for Patients With Untreated Age-Adjusted International Prognostic Index Low-Intermediate Risk, High-Intermediate Risk, or High Risk Diffuse Large B Cell Lymphoma [NCT00712582]Phase 296 participants (Actual)Interventional2008-07-01Completed
A Randomized Controlled Study of Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy [NCT02875457]Phase 3100 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab [NCT03811002]Phase 3545 participants (Anticipated)Interventional2019-07-26Recruiting
PHASE II STUDY OF ORAL ETOPOSIDE WITH PHARMACODYNAMIC MODELING IN RELAPSED NON-HODGKIN'S LYMPHOMA (IWF GRADES A-H) [NCT00002880]Phase 253 participants (Actual)Interventional1996-11-30Completed
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
Three Cycles Versus Six Cycles of Adjuvant Chemotherapy for the Patients With High-risk Retinoblastoma After Enucleation: Prospective Randomized Control Study [NCT01906814]Phase 3179 participants (Actual)Interventional2013-08-31Active, not recruiting
A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193]Phase 3218 participants (Actual)Interventional2008-01-15Active, not recruiting
A Phase II Study of Olaparib Plus Cediranib in Combination With Standard Therapy for Small Cell Lung Cancer [NCT02899728]Phase 29 participants (Actual)Interventional2018-03-30Terminated(stopped due to Inadequate accrual rate)
A Phase 1 Study of R-(-)-Gossypol (AT-101) in Combination With Cisplatin and Etoposide in Patients With Advanced Solid Tumors and Extensive-Stage Small Cell Lung Cancer [NCT00544596]Phase 127 participants (Actual)Interventional2007-09-30Completed
A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis [NCT02912702]Phase 3120 participants (Anticipated)Interventional2016-09-30Recruiting
A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL) [NCT05006664]Phase 233 participants (Anticipated)Interventional2021-10-31Not yet recruiting
Phase 2 Study of Alisertib as a Single Agent in Recurrent or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (AT/RT) and Extra-CNS Malignant Rhabdoid Tumors (MRT) and in Combination Therapy in Newly Diagnosed AT/RT [NCT02114229]Phase 2125 participants (Actual)Interventional2014-05-14Active, not recruiting
A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas [NCT00101205]Phase 140 participants (Actual)Interventional2004-11-30Terminated
A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation [NCT04177004]Phase 136 participants (Anticipated)Interventional2021-04-30Recruiting
A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody NSC # 742460]) in Combination With Intensive Multi-agent Interval Compressed Therapy for Patients With High-Risk Rhabdomyosarcoma [NCT01055314]Phase 2175 participants (Actual)Interventional2010-01-31Completed
A Multicentre Phase III Randomized Double Blind Placebo Controlled Trial of Pravastatin Added to First-Line Standard Chemotherapy in Patients With Small Lung Cancer [NCT00433498]Phase 3846 participants (Actual)Interventional2007-01-31Completed
A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 (ZARNESTRA, Tipifarnib, NSC #702818, IND #58,359) in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia (AML) [NCT00112853]Phase 1100 participants (Actual)Interventional2005-03-31Completed
A Phase I Study Investigating the Combination of RAD001 With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) [NCT01154439]Phase 111 participants (Actual)Interventional2010-10-31Completed
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma [NCT04759586]Phase 3244 participants (Anticipated)Interventional2021-10-05Recruiting
Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas [NCT03984448]Phase 2/Phase 3363 participants (Anticipated)Interventional2019-10-22Active, not recruiting
A Phase II Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-Host-Exhausting and Timely Dose-Reduced Mel-80-CFZ-TD-Pace Transplant(s) With Interspersed Mel-20-CFZ-TD-Pace With CFZ-RD and CFZ-D Ma [NCT02128230]Phase 220 participants (Actual)Interventional2014-06-10Terminated(stopped due to Low enrollment and Futility as determined by Amgen's Carfilzomib NASCR program.)
A Phase Ib Open-Label Study of LB-100 in Combination With Carboplatin/Etoposide/Atezolizumab in Untreated Extensive-Stage Small Cell Lung Carcinoma [NCT04560972]Phase 121 participants (Anticipated)Interventional2021-05-28Recruiting
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 Pilot, Pharmacodynamic Correlate, Multi-Institutional Trial of Sirolimus in Combination With Chemotherapy (Mitoxantrone, Etoposide, Cytarabine) for the Treatment of High Risk, Acute Myelogenous Leukemia [NCT01184898]36 participants (Actual)Interventional2010-07-31Completed
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation [NCT00653068]Phase 370 participants (Actual)Interventional2008-12-08Active, not recruiting
Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR) [NCT00526318]360 participants (Anticipated)Interventional2007-01-31Recruiting
A Phase Ⅰb/II Study of Surufatinib Combined With Chemotherapy Plus Toripalimab or Not in Patients With Small Cell Lung Cancer [NCT04996771]Phase 1/Phase 288 participants (Anticipated)Interventional2021-11-09Recruiting
HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Randomization to Either Single Cycle or [NCT02875314]Phase 4250 participants (Anticipated)Interventional2015-09-30Recruiting
Phase 1/2 Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma [NCT02432274]Phase 1/Phase 2117 participants (Actual)Interventional2014-12-29Completed
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. [NCT00336024]Phase 391 participants (Actual)Interventional2007-08-06Active, not recruiting
Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children >/= to 8 Months and <3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Stud [NCT00006461]Phase 382 participants (Actual)Interventional2000-10-31Completed
A Groupwide Phase II Study of Trastuzumab (Herceptin) in Metastatic Osteosarcoma Patients With Tumors That Overexpress HER2 [NCT00023998]Phase 280 participants (Actual)Interventional2001-07-31Completed
A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination With Vincristine And Pilot Assessment of Safety and Efficacy of Tirapazamine Combined With Multiagent Chemotherapy for First Relapse or Progressive Diseas [NCT00025363]Phase 2150 participants (Actual)Interventional2001-11-30Completed
A Phase I Study of PS-341 (NSC 681239), Carboplatin, and Etoposide in Patients With Advanced Solid Tumors Refractory to Standard Therapy [NCT00027898]Phase 127 participants (Actual)Interventional2002-01-31Completed
A Phase I Study Of OSI-774 (NSC #718781)-Based Multimodality Therapy For Inoperable Stage III Non Small Cell Lung Cancer [NCT00042835]Phase 148 participants (Actual)Interventional2002-05-31Terminated(stopped due to Administratively complete.)
Randomized Study of ICE Plus RITUXIMAB Versus DHAP Plus Rituximab in Previously Treated Patients With Diffuse Large B-cell Lymphoma, Followed by Randomized Maintenance With Rituximab [NCT00137995]Phase 3481 participants (Actual)Interventional2003-06-30Completed
Phase III Randomized Trial of Sequential High-Dose Chemotherapy Versus Standard Chemotherapy for the Treatment of Small Cell Lung Cancer [NCT00011921]Phase 3430 participants (Anticipated)Interventional1997-09-30Active, not recruiting
A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy With ZD1839 (NSC-715055) or Placebo in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer [NCT00020709]Phase 3840 participants (Actual)Interventional2001-06-30Completed
A Children's Oncology Group Pilot Study for the Treatment of Very High Risk Acute Lymphoblastic Leukemia in Children and Adolescents (Imatinib (STI571, GLEEVEC) NSC#716051) [NCT00022737]Phase 3220 participants (Actual)Interventional2002-10-31Completed
A Multicenter, Open-Label Feasibility Study of Daratumumab With Dose-Adjusted EPOCH in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV [NCT04139304]Early Phase 115 participants (Anticipated)Interventional2021-05-24Recruiting
Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors [NCT00536601]174 participants (Actual)Interventional2006-06-29Completed
Combination Chemotherapy (Methotrexate, Cyclophosphamide, And Etoposide Phosphate) Delivered In Conjunction With Osmotic Blood-Brain Barrier Disruption (BBBD), With Intraventricular Cytarabine +/- Intra-Ocular Chemotherapy, In Patients With Primary Centra [NCT00074178]Phase 222 participants (Actual)Interventional2000-01-31Completed
A Randomized Phase II Study Of Carboplatin And Etoposide With Or Without G3139 (NSC #683428, IND #58842) In Patients With Extensive Stage Small Cell Lung Cancer [NCT00042978]Phase 255 participants (Actual)Interventional2003-04-30Completed
A Phase I Trial Combining IDEC-Y2B8 And High-Dose Beam Chemotherapy With Hematopoietic Progenitor Cell Transplant In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma [NCT00058292]Phase 144 participants (Actual)Interventional2000-04-30Completed
A Phase III Randomized, Double Blind, Placebo Controlled Trial Of Carboplatin/Etoposide With Or Without Thalidomide In Small Cell Lung Cancer (Study 12) [NCT00061919]Phase 3724 participants (Actual)Interventional2003-04-30Completed
Adaptive-Dose to Mediastinum With Immunotherapy (Durvalumab MEDI4736) and Radiation in Locally-Advanced Non-Small Cell Lung Cancer [NCT04372927]Phase 21 participants (Actual)Interventional2021-12-10Terminated(stopped due to Terminated due to slow accrual)
A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung [NCT00537511]Phase 1/Phase 222 participants (Actual)Interventional2008-02-01Terminated(stopped due to This study was terminated for administrative reasons.)
A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC [NCT04696575]Phase 228 participants (Anticipated)Interventional2021-07-02Recruiting
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
A Randomized Phase II Trial of Tipifarnib (R115777, ZARNESTRA, NSC #702818) in Combination With Oral Etoposide (VP-16) in Elderly Adults With Newly Diagnosed, Previously Untreated Acute Myelogenous Leukemia (AML) [NCT00602771]Phase 284 participants (Actual)Interventional2008-01-31Completed
Randomized Phase III Trial of Chemotherapy vs. Pembrolizumab Plus Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma [NCT05711628]Phase 30 participants (Actual)Interventional2023-08-10Withdrawn(stopped due to Other - Protocol moved to Withdrawn)
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as Firs [NCT02375204]Phase 3420 participants (Actual)Interventional2015-08-05Active, not recruiting
A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma [NCT01231906]Phase 3642 participants (Actual)Interventional2010-11-22Active, not recruiting
Treatment of Adrenocortical Tumors With Surgery Plus Lymph Node Dissection and Multiagent Chemotherapy: A Groupwide Phase III Study [NCT00304070]Phase 378 participants (Actual)Interventional2007-05-03Completed
SPECTRA: SupraPhysiological Androgen to Enhance Chemotherapy TReatment Activity [NCT06039371]Phase 246 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Phase II Trial of Response-Adapted Second-Line Therapy for Hodgkin Lymphoma Using Anti-PD-1 Antibody Nivolumab ? ICE Chemotherapy as a Bridge to Autologous Hematopoietic Cell Transplant (NICE Trial) [NCT03016871]Phase 278 participants (Actual)Interventional2017-04-24Active, not recruiting
A Phase I Study Combining Ibrutinib With Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients With Relapsed or Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT02219737]Phase 126 participants (Actual)Interventional2014-09-12Completed
SIOP Intracranial Germ Cell Tumours Protocol [NCT00293358]Phase 3500 participants (Anticipated)Interventional1997-01-31Completed
Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors [NCT00301782]Phase 288 participants (Anticipated)Interventional2005-06-30Completed
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study [NCT00416819]10 participants (Actual)Interventional2003-09-30Completed
European Infant Neuroblastoma Study Final Protocol [NCT00417053]Phase 30 participants InterventionalActive, not recruiting
A Phase I Multicenter Study of Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors (CLOVER) [NCT03509012]Phase 1105 participants (Actual)Interventional2018-05-02Active, not recruiting
Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma [NCT00303810]567 participants (Actual)Interventional2001-01-31Completed
Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC [NCT01076231]Phase 1/Phase 234 participants (Actual)Interventional2010-01-31Completed
A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone) [NCT01501136]Phase 4200 participants (Anticipated)Interventional2011-01-31Recruiting
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910]Phase 229 participants (Actual)Interventional2012-11-30Completed
An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma [NCT01746992]Phase 4200 participants (Anticipated)Interventional2012-09-30Active, not recruiting
Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC) [NCT05058651]Phase 2/Phase 3189 participants (Anticipated)Interventional2022-06-28Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B [NCT04924101]Phase 2120 participants (Anticipated)Interventional2021-07-15Active, not recruiting
Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide for Refractory or Relapsed Aggressive B-cell Lymphomas [NCT01458366]Phase 1/Phase 238 participants (Actual)Interventional2011-11-09Completed
ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors [NCT01756989]Phase 250 participants (Anticipated)Interventional2005-01-31Completed
AUTOLOGOUS TRANSPLANTATION AND STEM CELL BASED-GENE THERAPY FOR THE TREATMENT OF HIV-ASSOCIATED LYMPHOMA [NCT01769911]0 participants (Actual)Interventional2015-02-28Withdrawn
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
Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid, or SAHA) in Combination With Cytosine Arabinoside (Ara-C) and Etoposide for Patients With Relapsed and/or Refractory Acute Leukemias, Myelodysplasias and Myeloproliferative Disorders [NCT00357305]Phase 125 participants (Actual)Interventional2006-05-31Completed
Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma [NCT00002649]Phase 3206 participants (Actual)Interventional1995-05-31Completed
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
A Phase I Study of Avelumab Plus Utomilumab-Based Combination Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma and Mantle Cell Lymphoma [NCT03440567]Phase 116 participants (Anticipated)Interventional2018-04-02Active, not recruiting
Phase I/Ib Study of Carfilzomib Plus Rituximab Plus Ifosfamide Plus Carboplatin Plus Etoposide (C-R-ICE) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT01959698]Phase 129 participants (Actual)Interventional2014-04-17Active, not recruiting
A Prospective Study of Intensified Conditioning Regimen With High-Dose-Etoposide for Allogeneic Hematopoietic Stem Cell Transplantation for Adult Acute Lymphoblastic Leukemia in China [NCT01457040]Phase 2/Phase 3200 participants (Actual)Interventional2011-10-31Completed
A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma [NCT00967369]Phase 220 participants (Actual)Interventional2009-08-24Completed
A Phase II Randomized Trial of Carboplatin and Topotecan; Flavopiridol, Mitoxantrone and Cytosine Arabinoside; and Sirolimus, Mitoxantrone, Etoposide and Cytosine Arabinoside for the Treatment of Adults With Primary Refractory or Initial Relapse of Acute [NCT00634244]Phase 292 participants (Actual)Interventional2008-10-31Completed
High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma [NCT02137096]Phase 31 participants (Actual)Interventional2014-06-30Terminated(stopped due to This is a rare disease, and enrollment was poor.)
Treatment of Stage IV Breast Cancer With Activated T Cells After Peripheral Blood Stem Cell Transplant (Pilot Phase II) [NCT00020722]Phase 27 participants (Actual)Interventional2007-08-31Terminated(stopped due to Lack of funding to continue study.)
Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent, Refractory or Recurrent Advanced (Stage III or IV), Epithelial Ovarian Cancer [NCT00003064]Phase 1/Phase 230 participants (Anticipated)Interventional1997-01-31Active, not recruiting
Phase III Study of MDR Modulation With PSC-833 (NSC #648265) Followed by Immunotherapy With rIL-2 (NSC #373364) vs. No Further Therapy in Previously Untreated Patients With AML >60 Years [NCT00003190]Phase 3640 participants (Actual)Interventional1998-01-31Completed
A Randomized Phase II Trial of EPOCH Given Either Concurrently or Sequentially With Rituximab in Patients With Intermediate- or High-Grade HIV-Associated B-cell Non-Hodgkin's Lymphoma [NCT00049036]Phase 2106 participants (Actual)Interventional2003-03-31Completed
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma [NCT00602667]Phase 2293 participants (Actual)Interventional2007-12-17Active, not recruiting
A Phase II Study of Pembrolizumab, Lenvatinib and Chemotherapy Combination in First Line Extensive-stage Small Cell Lung Cancer (ES-SCLC) [NCT05384015]Phase 285 participants (Anticipated)Interventional2022-11-07Recruiting
A Phase II Study of Bendamustine (B), Etoposide (E), Dexamethasone (D), and GCSF for Peripheral Blood Hematopoietic Stem Cell Mobilization (BED) [NCT01110135]Phase 243 participants (Actual)Interventional2010-08-31Completed
Phase 1 Study of Selinexor in Combination With Topoisomerase-II Inhibition in Acute Myeloid Leukemia [NCT02299518]Phase 123 participants (Actual)Interventional2015-05-18Completed
German Multicenter Study for Treatment Optimisation in Acute Lymphoblastic Leukemia in Adults and Adolescents Above 15 Years (Amend 3) (GMALL 07/2003) [NCT00198991]Phase 41,883 participants (Actual)Interventional2003-04-30Completed
Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming With Decitabine in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase 1/2 Study [NCT01729845]Phase 1/Phase 252 participants (Actual)Interventional2012-12-20Completed
A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia [NCT00186875]Phase 247 participants (Actual)Interventional2003-11-30Completed
Efficacy and Safety of First-line Etoposide/Platinum-based Chemotherapy Followed by Toripalimab Combined With Anlotinib for Maintenance in Extensive Small Cell Lung Cancer: A Single-arm, Multicentral Phase II Study [NCT04363255]Phase 220 participants (Anticipated)Interventional2020-05-01Not yet recruiting
Dasatinib With Ifosfamide, Carboplatin, Etoposide: A Pediatric Phase I/II Trial [NCT00788125]Phase 1/Phase 27 participants (Actual)Interventional2008-09-03Terminated(stopped due to Terminated early due a shift in resources after lackluster performance of the drug.)
Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated [NCT02870907]Phase 2185 participants (Anticipated)Interventional2010-03-31Recruiting
Phase I Study of Romidepsin (ISTODAX®) Plus ICE for Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma [NCT01590732]Phase 122 participants (Actual)Interventional2012-10-29Completed
A Phase II Study of CHOEP Induction Followed by Gemcitabine/Busulfan/Melphalan Autologous Stem Cell Transplantation for Patients With Newly Diagnosed T-Cell Lymphoma [NCT01746173]Phase 25 participants (Actual)Interventional2013-07-31Terminated(stopped due to Slow accrual and futility)
Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma. [NCT02063022]Phase 3278 participants (Actual)Interventional2009-01-22Completed
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China [NCT02405676]Phase 2/Phase 3200 participants (Anticipated)Interventional2015-01-31Active, not recruiting
Treatment Protocol for Relapsed Anaplastic Large Cell Lymphoma of Childhood and Adolescence [NCT00317408]96 participants (Anticipated)Interventional2004-04-30Active, not recruiting
A PHASE III STUDY IN CHILDREN WITH UNTREATED ACUTE MYELOGENOUS LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROME (MDS) [NCT00002798]Phase 3880 participants (Actual)Interventional1996-08-31Completed
A Study of Intensive-Dose Melphalan, Topotecan, and VP-16 Phosphate (MTV) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma [NCT00005792]Phase 1131 participants (Actual)Interventional1998-06-02Completed
Randomized Trial of Busulfan or Total Body Irradiation Conditioning Regimens for Children With Acute Lymphoblastic Leukemia [NCT00002961]Phase 343 participants (Actual)Interventional1995-10-31Terminated(stopped due to poor accrual)
A Phase II Study of Melphalan HCl for Injection (Propylene Glycol-free), Combined With Carmustine, Etoposide, and Cytarabine (BEAM Regimen) for Myeloablative Conditioning in Lymphoma Patients Undergoing Autologous Stem Cell Transplantation [NCT01969435]Phase 250 participants (Actual)Interventional2014-03-19Completed
Phase II Study to Evaluate the Efficacy of 12-month Neoadjuvant Chemotherapy in Terms of Disease-free Survival in Patients With Localized Digestive Neuroendocrine Carcinomas [NCT04268121]Phase 278 participants (Anticipated)Interventional2021-01-05Recruiting
Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL) [NCT01390584]Phase 26 participants (Actual)Interventional2013-05-24Terminated(stopped due to slow accrual)
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
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
B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021) [NCT05518383]Phase 4300 participants (Anticipated)Interventional2022-05-25Recruiting
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations [NCT02400281]Phase 1/Phase 228 participants (Actual)Interventional2015-09-30Completed
A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children With Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology [NCT01228331]Phase 2/Phase 3745 participants (Actual)Interventional2010-10-31Active, not recruiting
A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer [NCT03100955]Phase 3120 participants (Anticipated)Interventional2017-03-01Recruiting
A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma [NCT05991388]Phase 2/Phase 3210 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Prospective, Phase II Study to Evaluate the Efficacy of Addition of Progesterone to Standard Chemotherapy According to Etoposide-Doxorubicin-Cisplatin Scheme Plus Mitotane (EDP-M) in Patients With Advanced Adrenocortical Carcinoma (ACC) [NCT05913427]Phase 280 participants (Anticipated)Interventional2022-06-08Recruiting
A Phase II Trial of Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma [NCT05821088]Phase 237 participants (Anticipated)Interventional2023-06-29Recruiting
A Phase 2 Trial of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy (aTac-BEAM) Conditioning for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma [NCT04871607]Phase 233 participants (Anticipated)Interventional2021-11-02Recruiting
Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study [NCT03214003]235 participants (Actual)Interventional2017-06-30Completed
A Phase 2 Study of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients With CD30-Positive Peripheral T-Cell Lymphomas [NCT03113500]Phase 248 participants (Actual)Interventional2017-05-25Active, not recruiting
A Phase II Study of Yttrium-90-Labeled Anti-CD20 Monoclonal Antibody in Combination With High-Dose Beam Followed by Autologous Stem Cell Transplantation for Poor Risk/Relapsed B-Cell Lymphoma [NCT00695409]Phase 2122 participants (Actual)Interventional2008-03-18Completed
Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT) [NCT01602666]Phase 2262 participants (Actual)Interventional2012-05-29Active, not recruiting
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma [NCT00349778]Phase 2102 participants (Actual)Interventional2006-08-31Completed
A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-operative Chemotherapy [NCT00134030]Phase 31,334 participants (Actual)Interventional2005-11-14Completed
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC) [NCT01822496]Phase 259 participants (Actual)Interventional2013-11-04Terminated
Tandem Autotransplantation for Multiple Myeloma in Participants With Less Than 12 Months of Preceding Therapy, Incorporating Velcade (Bortezomib) With the Transplant Chemotherapy and During Maintenance [NCT01548573]Phase 219 participants (Actual)Interventional2012-05-31Terminated(stopped due to Met study stopping rules)
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
Multicenter Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Carmustine, Etoposide and Cytarabine (Modified BEAM Protocol) for T Cell Lymphoma Underwent Autologous Stem Cell Transplantation [NCT05814718]122 participants (Anticipated)Interventional2023-04-15Not yet recruiting
A Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Pediatric and Adolescent-Young Adults Patients With High Risk Solid Tumors [NCT04530487]Phase 240 participants (Anticipated)Interventional2020-08-19Recruiting
A Phase I/II Trial of Brentuximab Vedotin (BV), Ifosfamide (I), Carboplatin (C), and Etoposide (E) for Patients With Relapsed or Refractory Hodgkin Lymphoma (BV-ICE) [NCT02227199]Phase 1/Phase 245 participants (Actual)Interventional2014-10-10Active, not recruiting
BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Versus CEM (Carboplatin, Etoposide, Melphalan) in Lymphoma Patients as a Conditioning Regimen Before Autologous Hematopoietic Cell Transplantation [NCT05813132]60 participants (Actual)Interventional2022-12-01Completed
LS1781: Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients With Clonal Cytopenia of Undetermined Significance [NCT03418038]Phase 255 participants (Anticipated)Interventional2018-03-23Recruiting
Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma [NCT03117751]Phase 2/Phase 3790 participants (Actual)Interventional2017-03-29Active, not recruiting
A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049]Phase 35,937 participants (Actual)Interventional2012-02-29Active, not recruiting
Single Autologous Transplant Followed by Consolidation and Maintenance for Participants ≥ 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy [NCT01849783]Phase 241 participants (Actual)Interventional2013-04-04Completed
Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma [NCT00612430]Phase 259 participants (Actual)Interventional2007-03-31Completed
A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary [NCT01042522]Phase 263 participants (Actual)Interventional2010-02-08Active, not recruiting
A Biomarker Validation Study to Establish Whether Serial Flow Cytometric Measurements Predict Clinical Response to Sirolimus and MEC (Mitoxantrone Etoposide Cytarabine) Treatment in Patients With High-Risk Acute Myelogenous Leukemia [NCT02583893]Phase 239 participants (Actual)Interventional2015-10-07Completed
A Phase 1/2 Study of the Bromodomain Inhibitor ZEN003694 in Combination With Etoposide/Platinum in Patients With NUT Carcinoma [NCT05019716]Phase 1/Phase 255 participants (Anticipated)Interventional2022-07-13Recruiting
An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667) [NCT03407144]Phase 2340 participants (Anticipated)Interventional2018-04-09Active, not recruiting
A Pilot Study of Whole-body MRI-guided Intensity Modulated Radiation Therapy Combined With Systemic Chemotherapy Followed by High-Dose Chemotherapy With Busulfan, Melphalan and Topotecan and Stem Cell Rescue in Patients With Poor Risk Ewing's Sarcoma [NCT01795430]0 participants (Actual)Interventional2013-07-31Withdrawn(stopped due to No participants enrolled.)
A Phase I/II Study of Vorinostat Plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients With Relapsed or Refractory Lymphoid Malignancies or Untreated T- or Mantle Cell Lymphoma [NCT00601718]Phase 1/Phase 229 participants (Actual)Interventional2007-12-31Completed
Randomized, Phase II Trial of CHOP vs. Oral Chemotherapy With Concomitant Antiretroviral Therapy in Patients With HIV-Associated Lymphoma in Sub-Saharan Africa [NCT01775475]Phase 27 participants (Actual)Interventional2016-09-15Completed
A Phase 2 Study of Loncastuximab Tesirine and Rituximab (Lonca-R) Followed by DA-EPOCH-R in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma [NCT05600686]Phase 224 participants (Anticipated)Interventional2023-05-24Recruiting
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma [NCT02106988]Phase 240 participants (Anticipated)Interventional2015-01-16Recruiting
Phase I/II, Open-Label Study of R-ICE (Rituximab-Ifosfamide-Carboplatin-Etoposide) With Lenalidomide (R2-ICE) in Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL) [NCT02628405]Phase 1/Phase 263 participants (Actual)Interventional2016-05-20Active, not recruiting
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of a Sintilimab Plus ICE Regimen Versus a Placebo Plus ICE Regimen in Classic Hodgkin's Lymphoma Patients With First-line Standard Chemotherapy [NCT04044222]Phase 3240 participants (Anticipated)Interventional2019-10-21Recruiting
Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy [NCT03515707]Phase 20 participants (Actual)Interventional2018-07-10Withdrawn(stopped due to PI recommended closure)
UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma Ages 65 and Under: A Trial Enrolling Subjects to Standard Total Therapy 3 (S-TT3) [NCT00734877]Phase 3382 participants (Actual)Interventional2008-07-31Active, not recruiting
A Randomized Pilot Study of Human Lysozyme Goat Milk in Recipients of Standard Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation [NCT03531281]Phase 10 participants (Actual)Interventional2018-12-30Withdrawn(stopped due to Administratively withdrawn)
The Efficacy of Whole-ventricle Irradiation Plus Primary Boost in Patients With Localized Basal Ganglia Germ Cell Tumors: Prospective Phase II Study [NCT05124951]Phase 2150 participants (Anticipated)Interventional2021-09-15Recruiting
Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours [NCT02582697]Phase 3500 participants (Anticipated)Interventional2014-02-28Recruiting
A Study of Hematopoietic Stem Cell Supermobilization in Patients With Non-Hodgkin Lymphoma [NCT01408043]25 participants (Actual)Interventional2011-10-31Terminated(stopped 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
Phase I/II Study of Intravenous (IV) Busulfan and Etoposide (VP-16) Combined With Escalated Doses of Large Field Image-Guided Intensity Modulated Radiation Therapy (IMRT) Using Helical Tomotherapy as a Preparative Regimen for Allogeneic Hematopoietic Stem [NCT00540995]Phase 1/Phase 225 participants (Actual)Interventional2007-06-11Terminated(stopped due to Unable to safely escalate to TMLI doses that were hypothesized to be effective and less toxic than FTBI. Likely due to the giving of Busulfan prior to radiation delivery. Therefore, the study was abandoned and no further patients were accrued.)
A Phase 1 Study of Entinostat in Combination With Atezolizumab / Carboplatin / Etoposide in Previously Untreated Extensive-Stage Small Cell Lung Cancer [NCT04631029]Phase 13 participants (Actual)Interventional2021-04-27Completed
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.)
Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) +/- Rituximab (R) + Tafasitamab-cxix for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative (Ph-) B-cell Lymphoblastic Lymphoma/Leuke [NCT05453500]Phase 230 participants (Anticipated)Interventional2023-03-27Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00003389 (3) [back to overview]5-year Overall Survival
NCT00003389 (3) [back to overview]Failure-free Survival at 5 Years
NCT00003389 (3) [back to overview]Incidence of Second Cancers
NCT00003875 (4) [back to overview]Proportion of Patients Who Relapsed Associated With the Regimen
NCT00003875 (4) [back to overview]Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue
NCT00003875 (4) [back to overview]Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue
NCT00003875 (4) [back to overview]Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin
NCT00005803 (4) [back to overview]Engraftment of HLA Identical PBSC Allografts
NCT00005803 (4) [back to overview]Non-Relapse Mortality
NCT00005803 (4) [back to overview]Overall Survival (OS)
NCT00005803 (4) [back to overview]Progression Free-survival (PFS)
NCT00025259 (4) [back to overview]Grade 3 or 4 Non-hematologic Toxicity
NCT00025259 (4) [back to overview]Disease Response Assessed by Modified RECIST Criteria
NCT00025259 (4) [back to overview]Event-free Survival
NCT00025259 (4) [back to overview]Overall Survival
NCT00026208 (7) [back to overview]Early Treatment-related Toxicity
NCT00026208 (7) [back to overview]Frequency of Complete Response
NCT00026208 (7) [back to overview]Overall Survival (OS)
NCT00026208 (7) [back to overview]Progression-free Survival (PFS)
NCT00026208 (7) [back to overview]Second Hodgkin's Disease Progression
NCT00026208 (7) [back to overview]Late Treatment-related Toxicity
NCT00026208 (7) [back to overview]Survival at 5 and 10 Years
NCT00039377 (5) [back to overview]5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups
NCT00039377 (5) [back to overview]5 Year Overall Survival for Autologous & Allogeneic Transplant Groups
NCT00039377 (5) [back to overview]Overall Survival
NCT00039377 (5) [back to overview]Disease Free Survival
NCT00039377 (5) [back to overview]Number of Participants Who Achieved a BCR-ABL Response at 12 Months
NCT00049036 (1) [back to overview]Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment
NCT00053352 (4) [back to overview]Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
NCT00053352 (4) [back to overview]Overall Survival (OS)
NCT00053352 (4) [back to overview]Event-Free Survival (EFS)
NCT00053352 (4) [back to overview]Days Hospitalized for Patients Who Receive Chemotherapy
NCT00054327 (5) [back to overview]Number of Patients With Overall Survival at 2 Years.
NCT00054327 (5) [back to overview]Incidence of Recurrent Disease
NCT00054327 (5) [back to overview]Rates of Durable Engraftment
NCT00054327 (5) [back to overview]Toxicity as Measured by CTC v2.0
NCT00054327 (5) [back to overview]Graft-versus-host Disease (GVHD)
NCT00057811 (4) [back to overview]Minimal Residual Disease
NCT00057811 (4) [back to overview]Toxic Death
NCT00057811 (4) [back to overview]Response Rate
NCT00057811 (4) [back to overview]Grade ≥ 3 Stomatitis
NCT00057837 (3) [back to overview]Duration of Response
NCT00057837 (3) [back to overview]Overall Survival
NCT00057837 (3) [back to overview]Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)
NCT00066742 (3) [back to overview]Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.
NCT00066742 (3) [back to overview]Progression-Free Survival
NCT00066742 (3) [back to overview]Overall Survival
NCT00072384 (6) [back to overview]Toxicity Associated With Chemotherapy
NCT00072384 (6) [back to overview]Group D Eyes - Treatment Failure Within One Year
NCT00072384 (6) [back to overview]Group C Eyes - Treatment Failure Within One Year
NCT00072384 (6) [back to overview]Event-free Survival (EFS)
NCT00072384 (6) [back to overview]Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement
NCT00072384 (6) [back to overview]Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence
NCT00073918 (4) [back to overview]Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
NCT00073918 (4) [back to overview]5 Year Overall Survival
NCT00073918 (4) [back to overview]Progression-free Survival
NCT00073918 (4) [back to overview]Response Rate
NCT00074165 (1) [back to overview]Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
NCT00079040 (3) [back to overview]Overall Survival
NCT00079040 (3) [back to overview]Percentage of Participants Alive and Progression-free (PF) at 6 Months
NCT00079040 (3) [back to overview]Best Objective Response
NCT00098839 (4) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01%
NCT00098839 (4) [back to overview]Pharmacokinetics
NCT00098839 (4) [back to overview]Event-free Survival Rate
NCT00098839 (4) [back to overview]Remission Re-induction (CR2) Rate
NCT00134030 (3) [back to overview]Event-free Survival (EFS)
NCT00134030 (3) [back to overview]Percentage of Patients With Overall Survival
NCT00134030 (3) [back to overview]Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0
NCT00186875 (4) [back to overview]Overall Survival (OS)
NCT00186875 (4) [back to overview]Response Rate
NCT00186875 (4) [back to overview]Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
NCT00186875 (4) [back to overview]Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
NCT00186888 (27) [back to overview]Change in Cognitive Functioning
NCT00186888 (27) [back to overview]Number of Participants With Change in Size of Pineal Gland
NCT00186888 (27) [back to overview]Assessment of School Readiness
NCT00186888 (27) [back to overview]Mean Primary Visual Cortex Function: Cluster Size
NCT00186888 (27) [back to overview]Change in Parent Report of Social-Emotional Factors
NCT00186888 (27) [back to overview]Change in Distortion Product Otoacoustic Emissions (DPOAEs)
NCT00186888 (27) [back to overview]Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.
NCT00186888 (27) [back to overview]Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification
NCT00186888 (27) [back to overview]Change in Relevant Daily Living Skills
NCT00186888 (27) [back to overview]Change in Parenting Stress Index (PSI)
NCT00186888 (27) [back to overview]Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification
NCT00186888 (27) [back to overview]Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment
NCT00186888 (27) [back to overview]Event-free Survival of Eyes of Stratum B Patients
NCT00186888 (27) [back to overview]Event-free Survival of Stratum A Patients
NCT00186888 (27) [back to overview]Event-free Survival of Stratum B Patients Responding to Window Treatment
NCT00186888 (27) [back to overview]Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification
NCT00186888 (27) [back to overview]Ocular Survival of Stratum B Patients Responding to Window Treatment
NCT00186888 (27) [back to overview]Ocular Survival of Stratum A Patients
NCT00186888 (27) [back to overview]Ocular Survival of Eyes of Stratum B Patients
NCT00186888 (27) [back to overview]Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment
NCT00186888 (27) [back to overview]Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.
NCT00186888 (27) [back to overview]Mean Primary Visual Cortex Function: Maximum T-value
NCT00186888 (27) [back to overview]Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification
NCT00186888 (27) [back to overview]Stratum B Response to Window Therapy
NCT00186888 (27) [back to overview]Stratum B Response Rate of Early Stage Eyes to Window Therapy
NCT00186888 (27) [back to overview]Number of Patients Recommended for and Utilizing Rehabilitation Services
NCT00186888 (27) [back to overview]Number of Participants With Development of Pineal Cysts
NCT00191139 (5) [back to overview]Overall Survival
NCT00191139 (5) [back to overview]Progression-Free Survival
NCT00191139 (5) [back to overview]Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization
NCT00191139 (5) [back to overview]2-Year Survival
NCT00191139 (5) [back to overview]Number of Patients With Overall Tumor Response
NCT00302003 (4) [back to overview]Overall Survival
NCT00302003 (4) [back to overview]Intensive Therapy Free Survival (ITFS).
NCT00302003 (4) [back to overview]Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
NCT00302003 (4) [back to overview]Event Free Survival (EFS)
NCT00304070 (7) [back to overview]Complications Associated With Radical Adrenalectomy and RLND
NCT00304070 (7) [back to overview]Frequency of Tumor Spillage at the Time of Tumor Resection
NCT00304070 (7) [back to overview]Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.
NCT00304070 (7) [back to overview]Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.
NCT00304070 (7) [back to overview]Frequency of Lymph Node Involvement by Imaging.
NCT00304070 (7) [back to overview]Five Year Event-free Survival (EFS)
NCT00304070 (7) [back to overview]Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT00334815 (4) [back to overview]Overall Survival
NCT00334815 (4) [back to overview]Progression-free Survival
NCT00334815 (4) [back to overview]Response Rate (Confirmed or Unconfirmed Partial Response)
NCT00334815 (4) [back to overview]Adverse Events
NCT00335738 (9) [back to overview]Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding
NCT00335738 (9) [back to overview]Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT00335738 (9) [back to overview]Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)
NCT00335738 (9) [back to overview]Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)
NCT00335738 (9) [back to overview]Pathological Features Present At Diagnosis - Iris Infiltration (II)
NCT00335738 (9) [back to overview]Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)
NCT00335738 (9) [back to overview]Pathological Features Present at Diagnosis - Scleral Invasion (SI)
NCT00335738 (9) [back to overview]Event-free Survival (EFS)
NCT00335738 (9) [back to overview]Overall Survival (OS)
NCT00336024 (10) [back to overview]Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).
NCT00336024 (10) [back to overview]Rates of Gastrointestinal Toxicities
NCT00336024 (10) [back to overview]Number of Participants With Chronic Central Hypothyroidism
NCT00336024 (10) [back to overview]Percentage of Participants With Event Free Survival (EFS)
NCT00336024 (10) [back to overview]Number of Participants With Chronic Diabetes Insipidus
NCT00336024 (10) [back to overview]Number of Participants With Chronic Low Somatomedin C
NCT00336024 (10) [back to overview]Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism
NCT00336024 (10) [back to overview]Number of Participants With Secondary Malignancies
NCT00336024 (10) [back to overview]Percentage of Participants With Any Acute Adverse Events
NCT00336024 (10) [back to overview]Rates of Nutritional Toxicities
NCT00349778 (3) [back to overview]Overall Participant Survival (OS)
NCT00349778 (3) [back to overview]Number of Participants With Pulmonary Toxicity
NCT00349778 (3) [back to overview]Number of Participants That Relapse After Autologous Transplantation
NCT00354107 (1) [back to overview]Response
NCT00369317 (10) [back to overview]Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program
NCT00369317 (10) [back to overview]Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program
NCT00369317 (10) [back to overview]Event-free Survival (EFS) at 3 Years
NCT00369317 (10) [back to overview]Induction Remission Rate
NCT00369317 (10) [back to overview]Overall Survival (OS) at 3 Years
NCT00369317 (10) [back to overview]Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT00369317 (10) [back to overview]Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry
NCT00369317 (10) [back to overview]Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis
NCT00369317 (10) [back to overview]Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry
NCT00369317 (10) [back to overview]Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program
NCT00379340 (4) [back to overview]Event Free Survival (EFS) Probability
NCT00379340 (4) [back to overview]Event Free Survival Probability
NCT00379340 (4) [back to overview]Event Free Survival Probability
NCT00379340 (4) [back to overview]Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease
NCT00381680 (6) [back to overview]Frequency and Severity of Adverse Effects
NCT00381680 (6) [back to overview]Event Free Survival (EFS)
NCT00381680 (6) [back to overview]Adjusted Event Free Survival
NCT00381680 (6) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
NCT00381680 (6) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
NCT00381680 (6) [back to overview]Event Free Survival. EFS
NCT00392990 (4) [back to overview]Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
NCT00392990 (4) [back to overview]Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
NCT00392990 (4) [back to overview]Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen
NCT00392990 (4) [back to overview]Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)
NCT00416598 (2) [back to overview]Disease-free Survival (DFS) Rate at 1 Year
NCT00416598 (2) [back to overview]Number of Participants Who Completed Maintenance Decitabine.
NCT00439556 (2) [back to overview]Number of Participants With Dose Limiting Toxicity (DLT)
NCT00439556 (2) [back to overview]Disease-free Survival
NCT00453154 (4) [back to overview]Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)
NCT00453154 (4) [back to overview]Overall Survival
NCT00453154 (4) [back to overview]Progression-free Survival (Phase II)
NCT00453154 (4) [back to overview]Number of Participants With Overall Tumor Response
NCT00505921 (1) [back to overview]Participant Progression Free Survival at 2 Years
NCT00536601 (8) [back to overview]Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
NCT00536601 (8) [back to overview]Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
NCT00536601 (8) [back to overview]Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
NCT00536601 (8) [back to overview]Response Rate (Complete Remission)
NCT00536601 (8) [back to overview]Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
NCT00536601 (8) [back to overview]Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
NCT00536601 (8) [back to overview]Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
NCT00536601 (8) [back to overview]Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
NCT00537511 (7) [back to overview]Overall Survival
NCT00537511 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase
NCT00537511 (7) [back to overview]Maximum Tolerated Dose (MTD)
NCT00537511 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase
NCT00537511 (7) [back to overview]Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase
NCT00537511 (7) [back to overview]Duration of Response
NCT00537511 (7) [back to overview]Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)
NCT00540995 (1) [back to overview]Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I)
NCT00549848 (6) [back to overview]Probability of Event-free Survival
NCT00549848 (6) [back to overview]Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
NCT00549848 (6) [back to overview]Probability of CNS Relapse
NCT00549848 (6) [back to overview]Probability of Overall Survival
NCT00549848 (6) [back to overview]Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
NCT00549848 (6) [back to overview]Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
NCT00554788 (3) [back to overview]Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT00554788 (3) [back to overview]Event-free Survival (EFS)
NCT00554788 (3) [back to overview]Response Rate to the Induction Phase of the Regimen
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
NCT00557193 (10) [back to overview]Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
NCT00557193 (10) [back to overview]Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) for Patients on Arm A
NCT00557193 (10) [back to overview]Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
NCT00557193 (10) [back to overview]Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT)
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00557193 (10) [back to overview]Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
NCT00567567 (14) [back to overview]Type of Surgical or Radiotherapy Complication
NCT00567567 (14) [back to overview]Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
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]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]Topotecan Systemic Clearance
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]Event-free Survival Rate
NCT00567567 (14) [back to overview]Incidence Rate of Local Recurrence
NCT00567567 (14) [back to overview]Intraspinal Extension
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
NCT00567567 (14) [back to overview]Proportion of Patients With a Polymorphism
NCT00567567 (14) [back to overview]Response After Induction Therapy
NCT00567567 (14) [back to overview]Surgical Response
NCT00571493 (3) [back to overview]Progression-free Survival (PFS), and Overall Survival (OS)
NCT00571493 (3) [back to overview]Preliminary Estimate of Overall Response Rate (ORR)
NCT00571493 (3) [back to overview]Maximum Tolerated Dose (MTD) of Bortezomib
NCT00576979 (1) [back to overview]Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)
NCT00578864 (5) [back to overview]Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy
NCT00578864 (5) [back to overview]Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
NCT00578864 (5) [back to overview]Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.
NCT00578864 (5) [back to overview]Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.
NCT00578864 (5) [back to overview]Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.
NCT00601718 (4) [back to overview]Maximum Tolerated Dose of Vorinostat
NCT00601718 (4) [back to overview]Safety and Toxicity According to CTCAE v3.0
NCT00601718 (4) [back to overview]Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment
NCT00601718 (4) [back to overview]Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy
NCT00602667 (62) [back to overview]Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan
NCT00602667 (62) [back to overview]Percent of Patients With Sustained Objective Responses Rate After Consolidation
NCT00602667 (62) [back to overview]Percent of PET Scans With Loss of Signal Intensity
NCT00602667 (62) [back to overview]Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients
NCT00602667 (62) [back to overview]Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup
NCT00602667 (62) [back to overview]Percentage of Patients With Objective Responses Rate to Induction Chemotherapy
NCT00602667 (62) [back to overview]Rate of Distant Disease Progression
NCT00602667 (62) [back to overview]Rate of Local Disease Progression
NCT00602667 (62) [back to overview]Topotecan Apparent Oral Clearance in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]Pharmacogenetic Variation on Central Nervous System Transmitters
NCT00602667 (62) [back to overview]Numbers of Patients With Gene Alterations
NCT00602667 (62) [back to overview]Number of Successful Collections for Frozen and Fixed Tumor Samples
NCT00602667 (62) [back to overview]Number of Participants With Chromosomal Abnormalities
NCT00602667 (62) [back to overview]Number and Type of Genetic Polymorphisms
NCT00602667 (62) [back to overview]Concentration of Cerebrospinal Fluid Neurotransmitters
NCT00602667 (62) [back to overview]Topotecan Clearance in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 2
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]Cyclophosphamide Clearance in Induction Chemotherapy
NCT00602667 (62) [back to overview]Erlotinib Apparent Oral Clearance
NCT00602667 (62) [back to overview]Erlotinib Apparent Volume of Central Compartment
NCT00602667 (62) [back to overview]Erlotinib AUC0-24h
NCT00602667 (62) [back to overview]Event-free Survival (EFS) Compared to Historical Controls
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received
NCT00602667 (62) [back to overview]Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 2
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate AUC0-66h in Induction Cycle 4
NCT00602667 (62) [back to overview]Numbers of Patients With Molecular Abnormalities by Tumor Type
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 2
NCT00602667 (62) [back to overview]Topotecan AUC0-24h in Consolidation Chemotherapy
NCT00602667 (62) [back to overview]Topotecan AUC0-24h in Maintenance Chemotherapy
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Clearance in Induction Cycle 4
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 1
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 3
NCT00602667 (62) [back to overview]Methotrexate Volume of Central Compartment in Induction Cycle 4
NCT00602667 (62) [back to overview]OSI-420 AUC0-24h
NCT00602667 (62) [back to overview]Overall Survival (OS) Compared to Historical Controls
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602667 (62) [back to overview]4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1
NCT00602667 (62) [back to overview]CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2
NCT00602771 (1) [back to overview]Complete Response
NCT00612430 (5) [back to overview]Safety of Study Treatment Regimen
NCT00612430 (5) [back to overview]6 Month Progression-Free Survival (PFS)
NCT00612430 (5) [back to overview]Median Overall Survival (OS)
NCT00612430 (5) [back to overview]Median Progression-Free Survival
NCT00612430 (5) [back to overview]Objective Response Rate
NCT00618813 (5) [back to overview]Incidence of Death
NCT00618813 (5) [back to overview]Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12
NCT00618813 (5) [back to overview]Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22
NCT00618813 (5) [back to overview]Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28
NCT00618813 (5) [back to overview]Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37
NCT00634244 (2) [back to overview]The Rate of Complete Remission (CR+CRi)
NCT00634244 (2) [back to overview]The Rate of Treatment Failure
NCT00653068 (4) [back to overview]Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy
NCT00653068 (4) [back to overview]Toxic Death
NCT00653068 (4) [back to overview]Overall Survival (OS)
NCT00653068 (4) [back to overview]Event-free Survival
NCT00666588 (5) [back to overview]Dose Limiting Toxicity
NCT00666588 (5) [back to overview]Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1
NCT00666588 (5) [back to overview]Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion
NCT00666588 (5) [back to overview]NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)
NCT00666588 (5) [back to overview]Proteasome Inhibition Activity
NCT00695409 (8) [back to overview]Time to Neutrophil Recovery
NCT00695409 (8) [back to overview]Time to Platelet Recovery
NCT00695409 (8) [back to overview]2-Year Cumulative Incidence of Progression
NCT00695409 (8) [back to overview]100-Day Treatment-Related Mortality
NCT00695409 (8) [back to overview]2-Year Overall Survival
NCT00695409 (8) [back to overview]2-Year Progression-Free Survival
NCT00695409 (8) [back to overview]Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT
NCT00695409 (8) [back to overview]Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML
NCT00712582 (2) [back to overview]2-year PFS From the Start of Induction Therapy Conditional
NCT00712582 (2) [back to overview]Overall Survival at 1 Year
NCT00720109 (5) [back to overview]Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
NCT00720109 (5) [back to overview]Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
NCT00720109 (5) [back to overview]Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
NCT00720109 (5) [back to overview]Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
NCT00720109 (5) [back to overview]Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
NCT00788125 (1) [back to overview]Maximum Administered Dose of Dasatinib (Phase I)
NCT00792948 (3) [back to overview]Continuous Complete Remission (CCR) Rate
NCT00792948 (3) [back to overview]Overall Survival (OS)
NCT00792948 (3) [back to overview]Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
NCT00873093 (7) [back to overview]Event Free Survival
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2
NCT00873093 (7) [back to overview]Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
NCT00873093 (7) [back to overview]Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy
NCT00873093 (7) [back to overview]Severe Adverse Events (SAE) Rate.
NCT00873093 (7) [back to overview]Toxic Death Rate
NCT00887159 (4) [back to overview]PFS
NCT00887159 (4) [back to overview]Progression-free Survival (PFS)
NCT00887159 (4) [back to overview]Response Rate
NCT00887159 (4) [back to overview]Overall Survival (OS)
NCT00967369 (4) [back to overview]PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy.
NCT00967369 (4) [back to overview]Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
NCT00967369 (4) [back to overview]Progression Free Survival (PFS) Rate at 12 Months
NCT00967369 (4) [back to overview]Overall Survival (OS) Rate at 24 Months
NCT00977561 (1) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00992446 (4) [back to overview]Median Time to Disease Progression
NCT00992446 (4) [back to overview]Toxicity of Vorinostat Bortezomib Maintenance Therapy After Autologous Transplant
NCT00992446 (4) [back to overview]Event-free Survival
NCT00992446 (4) [back to overview]Overall Survival
NCT01008462 (7) [back to overview]Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
NCT01008462 (7) [back to overview]Event-Free Survival (EFS)
NCT01008462 (7) [back to overview]Number of Patients Who Engrafted
NCT01008462 (7) [back to overview]Number of Patients Who Had Infections
NCT01008462 (7) [back to overview]Number of Patients With Relapsed/Progressive Disease
NCT01008462 (7) [back to overview]Overall Survival
NCT01008462 (7) [back to overview]Non-relapse Mortality (NRM)
NCT01026220 (7) [back to overview]Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
NCT01026220 (7) [back to overview]Event Free Survival
NCT01026220 (7) [back to overview]Safety Analysis and Monitoring of Toxic Death
NCT01026220 (7) [back to overview]Relapse-free Survival
NCT01026220 (7) [back to overview]Overall Survival
NCT01026220 (7) [back to overview]Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
NCT01026220 (7) [back to overview]Second-event-free Survival
NCT01035463 (3) [back to overview]Event-free Survival
NCT01035463 (3) [back to overview]Maximum Tolerated Dose of Lenalidomide (Phase I)
NCT01035463 (3) [back to overview]Overall Survival
NCT01042522 (3) [back to overview]Tumor Response Rate
NCT01042522 (3) [back to overview]Progression-free Survival (PFS)
NCT01042522 (3) [back to overview]Overall Survival (OS)
NCT01055314 (5) [back to overview]Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0
NCT01055314 (5) [back to overview]Response Rate (CR + PR)
NCT01055314 (5) [back to overview]Event-Free Survival
NCT01055314 (5) [back to overview]Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment
NCT01055314 (5) [back to overview]Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment
NCT01076231 (4) [back to overview]Late Toxicity
NCT01076231 (4) [back to overview]Pathologic CR Rate
NCT01076231 (4) [back to overview]Dose-limiting Toxicity
NCT01076231 (4) [back to overview]Number of Participants Deemed Feasible to Receive Intervention
NCT01092182 (5) [back to overview]Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval
NCT01092182 (5) [back to overview]Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval
NCT01092182 (5) [back to overview]Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2
NCT01092182 (5) [back to overview]Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval
NCT01092182 (5) [back to overview]Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
NCT01096368 (10) [back to overview]EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
NCT01096368 (10) [back to overview]EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy
NCT01096368 (10) [back to overview]OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
NCT01096368 (10) [back to overview]EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation
NCT01096368 (10) [back to overview]Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only
NCT01096368 (10) [back to overview]OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.
NCT01097057 (4) [back to overview]Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)
NCT01097057 (4) [back to overview]Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg
NCT01097057 (4) [back to overview]Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days
NCT01097057 (4) [back to overview]Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days
NCT01110135 (1) [back to overview]Successful Mobilization and Collection of PBSCs
NCT01132807 (3) [back to overview]Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD
NCT01132807 (3) [back to overview]Complete Response Rate
NCT01132807 (3) [back to overview]36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.
NCT01175356 (3) [back to overview]Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
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
NCT01184898 (4) [back to overview]Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC
NCT01184898 (4) [back to overview]Complete Response
NCT01184898 (4) [back to overview]Complete Response in the Absence of Platelet Recovery
NCT01184898 (4) [back to overview]Partial Response
NCT01193842 (14) [back to overview]Changes in Human Immunodeficiency Virus (HIV) Viral Load
NCT01193842 (14) [back to overview]Changes in Absolute CD4 Cell Counts (Phase I)
NCT01193842 (14) [back to overview]Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
NCT01193842 (14) [back to overview]Tumor Response (Phase I)
NCT01193842 (14) [back to overview]Change in CD8 Cell Counts (Phase I)
NCT01193842 (14) [back to overview]Recommended Phase II Dose of Vorinostat Determined According to Dose-limiting Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase I)
NCT01193842 (14) [back to overview]Event-free Survival (EFS) (Phase II)
NCT01193842 (14) [back to overview]Overall Survival (OS) (Phase II)
NCT01193842 (14) [back to overview]Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)
NCT01193842 (14) [back to overview]Changes in Human Herpes Virus (HHV)-8 Viral Load
NCT01193842 (14) [back to overview]Changes in Human Herpes Virus (HHV)-8 Viral Load
NCT01193842 (14) [back to overview]Changes in Epstein-Barr Virus (EBV) Viral Load
NCT01193842 (14) [back to overview]Pharmacokinetic Clearance (Phase I)
NCT01193842 (14) [back to overview]Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
NCT01220297 (5) [back to overview]Overall Survival
NCT01220297 (5) [back to overview]Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)
NCT01220297 (5) [back to overview]Acute GvHD (Grade 3 to 4)
NCT01220297 (5) [back to overview]Disease-free Survival (DFS)
NCT01220297 (5) [back to overview]Veno-occlusive Disease (VoD)
NCT01231906 (1) [back to overview]Event-Free Survival
NCT01256398 (6) [back to overview]Response
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]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]Disease Free Survival (DFS)
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]Overall Survival (OS)
NCT01336933 (6) [back to overview]Percent of Patients Who Proceeded With Transplant
NCT01336933 (6) [back to overview]Overall Survival (OS)
NCT01336933 (6) [back to overview]Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))
NCT01336933 (6) [back to overview]Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment
NCT01336933 (6) [back to overview]Event Free Survival (EFS)
NCT01336933 (6) [back to overview]To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events
NCT01342887 (1) [back to overview]Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium
NCT01371981 (18) [back to overview]OS for Patients on Arm C, Cohort 1
NCT01371981 (18) [back to overview]EFS for Patients on Arm C, Cohort 3
NCT01371981 (18) [back to overview]EFS for Patients on Arm C, Cohort 2
NCT01371981 (18) [back to overview]EFS for Patients on Arm C, Cohort 1
NCT01371981 (18) [back to overview]Change in Shortening Fraction
NCT01371981 (18) [back to overview]Total Scale Score From Parent-reported Pediatric Quality of Life Inventory Module
NCT01371981 (18) [back to overview]Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations
NCT01371981 (18) [back to overview]Change in Ejection Fraction
NCT01371981 (18) [back to overview]Bortezomib Clearance
NCT01371981 (18) [back to overview]Total Scale Score From Parent-reported Multidimensional Fatigue Scale Module
NCT01371981 (18) [back to overview]Total Scale Score From Parent-reported Cancer Module
NCT01371981 (18) [back to overview]Sorafenib Steady State Concentration
NCT01371981 (18) [back to overview]Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations
NCT01371981 (18) [back to overview]Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy
NCT01371981 (18) [back to overview]Proportion of High Risk Children Without HR FLT3/ITD+ Converting From Positive MRD at End of Induction I to Negative MRD at the End of Induction II
NCT01371981 (18) [back to overview]Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations
NCT01371981 (18) [back to overview]OS for Patients on Arm C, Cohort 3
NCT01371981 (18) [back to overview]OS for Patients on Arm C, Cohort 2
NCT01390584 (5) [back to overview]Overall Survival
NCT01390584 (5) [back to overview]Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment
NCT01390584 (5) [back to overview]Complete Response (CR) Rate After Induction Treatment
NCT01390584 (5) [back to overview]Proportion of Patients Who Are PET Negative After Induction Treatment
NCT01390584 (5) [back to overview]Progression-free Survival Rate
NCT01408043 (11) [back to overview]Progression-free Survival
NCT01408043 (11) [back to overview]Overall Survival
NCT01408043 (11) [back to overview]Need for Remobilization
NCT01408043 (11) [back to overview]Length of Hospital Stay in Super Mobilizers and Normal Mobilizers
NCT01408043 (11) [back to overview]Collection Using Plerixafor, Etoposide, and Filgrastim
NCT01408043 (11) [back to overview]Neutrophil Recovery in Super Mobilizers and Normal Mobilizers
NCT01408043 (11) [back to overview]Number of Days of Apheresis Required
NCT01408043 (11) [back to overview]Number of Transfusion Requirements
NCT01408043 (11) [back to overview]Overall Survival in Supermobilizers and Normal Mobilizers
NCT01408043 (11) [back to overview]Platelet Recovery in Super Mobilizers and Normal Mobilizers
NCT01408043 (11) [back to overview]Progression-free Survival in Supermobilizers and Normal Mobilizers
NCT01458366 (8) [back to overview]Overall Complete Response (CR) and Partial Response (PR) Rate
NCT01458366 (8) [back to overview]Phase I: Overall Frequency of Response
NCT01458366 (8) [back to overview]Overall Frequency of Response With Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide at Maximum Tolerated Dose (MTD)
NCT01458366 (8) [back to overview]Overall Progression-Free Survival
NCT01458366 (8) [back to overview]Overall Proportion of Patients Who Are Able to Undergo Stem Cell Transplant (SCT)
NCT01458366 (8) [back to overview]Overall Safety and Tolerability of the Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide
NCT01458366 (8) [back to overview]Phase I: Maximum-Tolerated Dose of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (BOCE)
NCT01458366 (8) [back to overview]Total Overall Survival for Transplant vs Non-transplant
NCT01548573 (4) [back to overview]Overall Survival
NCT01548573 (4) [back to overview]Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.
NCT01548573 (4) [back to overview]Identification of Drug Resistant Genes
NCT01548573 (4) [back to overview]Event-Free Survival (EFS)
NCT01602666 (6) [back to overview]Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed
NCT01602666 (6) [back to overview]Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
NCT01602666 (6) [back to overview]Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL
NCT01602666 (6) [back to overview]3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy
NCT01602666 (6) [back to overview]Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)
NCT01602666 (6) [back to overview]3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation
NCT01642251 (5) [back to overview]Overall Response Rate (ORR)
NCT01642251 (5) [back to overview]Overall Survival (OS)
NCT01642251 (5) [back to overview]Recommended Phase II Dose (Phase I)
NCT01642251 (5) [back to overview]Progression Free Survival (Phase II)
NCT01642251 (5) [back to overview]Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start
NCT01729845 (4) [back to overview]Overall Survival
NCT01729845 (4) [back to overview]Duration of Relapse-free Survival (for Patients Achieving CR or CRp)
NCT01729845 (4) [back to overview]Remission Rate Including CR and CRp
NCT01729845 (4) [back to overview]Most Efficacious and Tolerated Dosage of Decitabine (Period 1)
NCT01746173 (2) [back to overview]24-month Progression-Free Survival Rate
NCT01746173 (2) [back to overview]Induction Response
NCT01775475 (8) [back to overview]Proportion of Patients Who Are Adherent to Chemotherapy
NCT01775475 (8) [back to overview]Change in Absolute CD4 Count From Baseline to Post-treatment
NCT01775475 (8) [back to overview]Number of Patients Who Complete Treatment
NCT01775475 (8) [back to overview]Overall Response Rate
NCT01775475 (8) [back to overview]Overall Survival
NCT01775475 (8) [back to overview]Participants Who Experienced an Adverse Event
NCT01775475 (8) [back to overview]Progression-free Survival
NCT01775475 (8) [back to overview]Proportion of Patients Who Are Adherent to Antiretroviral Therapy
NCT01798004 (1) [back to overview]The Tolerability of BuMel Regimen
NCT01822496 (6) [back to overview]Progression-free Survival
NCT01822496 (6) [back to overview]Number of Patients With Grade 3-5 Adverse Events
NCT01822496 (6) [back to overview]Percentage of Patients With Complete or Partial Response
NCT01822496 (6) [back to overview]Overall Survival
NCT01822496 (6) [back to overview]Local-regional Progression-free Survival
NCT01822496 (6) [back to overview]Distant Progression-free Survival
NCT01849783 (4) [back to overview]Median Progression Free Survival (mPFS)
NCT01849783 (4) [back to overview]Mean Change in Quality-Of-Life Indicators Post-Transplant
NCT01849783 (4) [back to overview]Percentage of Participants With Serious Treatment-Related Complications
NCT01849783 (4) [back to overview]Percentage of Participants Able to Complete Full Course Therapy
NCT01921387 (4) [back to overview]Progression-free Survival Following Autologous Stem Cell Transplant (ASCT)
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
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]Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA
NCT01959698 (6) [back to overview]Overall Response Rate (PR + CR)
NCT01959698 (6) [back to overview]MTD Defined as the Dose of Carfilzomib Added to Standard R-ICE Chemotherapy Which, if Exceeded, Would Put the Patient at an Undesirable Risk of Medically Unacceptable Dose-limiting Toxicities (Phase I)
NCT01959698 (6) [back to overview]Complete Response Rate According to the International Working Group Response Criteria as Reported by the Revised Cheson Criteria
NCT01959698 (6) [back to overview]Overall Survival
NCT01959698 (6) [back to overview]Toxicity of the Addition of Carfilzomib to R-ICE at the MTD, Assessed by the CTEP Version 4.0 of the NCI CTCAE
NCT01959698 (6) [back to overview]Progression-free Survival
NCT01969435 (11) [back to overview]Time to Engraftment (Neutrophil)
NCT01969435 (11) [back to overview]Relapse Free Survival
NCT01969435 (11) [back to overview]Progression-free Survival Rate (PFS)
NCT01969435 (11) [back to overview]Progression-free Survival (PFS) Rate
NCT01969435 (11) [back to overview]Overall Survival (OS) Rate
NCT01969435 (11) [back to overview]Disease-free Survival
NCT01969435 (11) [back to overview]Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events
NCT01969435 (11) [back to overview]Efficacy as Measured by Response Rates
NCT01969435 (11) [back to overview]Time to Engraftment (Platelet)
NCT01969435 (11) [back to overview]Treatment-related Mortality (TRM)
NCT01969435 (11) [back to overview]Disease-free Survival
NCT01979536 (3) [back to overview]Prognostic Significance of Minimal Residual Disease
NCT01979536 (3) [back to overview]Event Free Survival (EFS)
NCT01979536 (3) [back to overview]Occurrence of Grade 3+ Non-hematologic Adverse Events
NCT02017964 (5) [back to overview]Percentage of Patients With Responses at 189 Days
NCT02017964 (5) [back to overview]Overall Survival (OS)
NCT02017964 (5) [back to overview]Event-free Survival (EFS)
NCT02017964 (5) [back to overview]Progression-free Survival (PFS)
NCT02017964 (5) [back to overview]Percentage of Patients With Responses at 273 Days
NCT02101853 (4) [back to overview]Overall Survival (OS) of HR and IR Relapse Patients
NCT02101853 (4) [back to overview]Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
NCT02101853 (4) [back to overview]Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
NCT02101853 (4) [back to overview]Overall Survival (OS) of LR Relapse Patients
NCT02112916 (6) [back to overview]Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
NCT02112916 (6) [back to overview]Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
NCT02112916 (6) [back to overview]Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
NCT02112916 (6) [back to overview]EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
NCT02112916 (6) [back to overview]EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
NCT02112916 (6) [back to overview]EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
NCT02128230 (1) [back to overview]The Remission Rate for Participants With High-risk Myeloma
NCT02166463 (3) [back to overview]Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review
NCT02166463 (3) [back to overview]Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale
NCT02166463 (3) [back to overview]Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
NCT02227199 (4) [back to overview]Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy
NCT02227199 (4) [back to overview]2 Year Overall Survival
NCT02227199 (4) [back to overview]Percentage of Patients That Achieve a Complete Remission Following Study Treatment
NCT02227199 (4) [back to overview]2 Year Progression-free Survival
NCT02306161 (3) [back to overview]Frequency of Toxicity-events
NCT02306161 (3) [back to overview]Event-free Survival
NCT02306161 (3) [back to overview]Overall Survival
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
NCT02432274 (23) [back to overview]Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
NCT02432274 (23) [back to overview]Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
NCT02432274 (23) [back to overview]Cohort 2A: Number of Participants With Best Overall Response (BOR)
NCT02432274 (23) [back to overview]Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4
NCT02432274 (23) [back to overview]Cohorts 1, 2B, 3A, and 3B: Objective Response Rate (ORR)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Time to Progression (TTP)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Progression-free Survival (PFS)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Overall Survival (OS)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Who Experienced Disease Control
NCT02432274 (23) [back to overview]Cohort 1: Recommended Dose (RD) of Lenvatinib
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Experienced Clinical Benefit
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Duration of Response (DOR)
NCT02432274 (23) [back to overview]Cohort 3A: Recommended Dose (RD) of Lenvatinib When Given in Combination With Etoposide and Ifosfamide
NCT02432274 (23) [back to overview]Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
NCT02432274 (23) [back to overview]Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
NCT02432274 (23) [back to overview]Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
NCT02481310 (2) [back to overview]To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R.
NCT02481310 (2) [back to overview]12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)
NCT02483000 (3) [back to overview]Incidence of Toxicity, Defined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
NCT02483000 (3) [back to overview]Dosimetry of Yttrium Y 90 DOTA-biotin
NCT02483000 (3) [back to overview]Overall Survival
NCT02561273 (7) [back to overview]Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)
NCT02561273 (7) [back to overview]Overall Survival
NCT02561273 (7) [back to overview]Progression-free Survival
NCT02561273 (7) [back to overview]Overall Response Rate
NCT02561273 (7) [back to overview]Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP
NCT02561273 (7) [back to overview]Complete Response Rate (Phase II)
NCT02561273 (7) [back to overview]Number of Participants With Adverse Events Graded According to CTC (Phase II)
NCT02626338 (1) [back to overview]Clinical Response to Crenolanib With Standard Salvage Chemotherapy
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
NCT03023046 (5) [back to overview]Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
NCT03023046 (5) [back to overview]Overall Survival
NCT03023046 (5) [back to overview]Number of Participants With Morphological Complete Response Rate
NCT03023046 (5) [back to overview]Number of Participants With Adverse Events
NCT03023046 (5) [back to overview]Event-free Survival
NCT03113500 (2) [back to overview]Overall Survival at 1 Year
NCT03113500 (2) [back to overview]Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy
NCT03382561 (3) [back to overview]Progression-free Survival (PFS)
NCT03382561 (3) [back to overview]Overall Survival (OS)
NCT03382561 (3) [back to overview]Response Rate
NCT03786783 (5) [back to overview]Event-free Survival
NCT03786783 (5) [back to overview]Overall Survival
NCT03786783 (5) [back to overview]Response Rate
NCT03786783 (5) [back to overview]Percentage of Participants With Unacceptable Toxicity
NCT03786783 (5) [back to overview]"Percentage of Participants Who Are Feasibility Failure"
NCT04372927 (4) [back to overview]Frequency of Adverse Events
NCT04372927 (4) [back to overview]Overall Survival (OS)
NCT04372927 (4) [back to overview]Response Rate
NCT04372927 (4) [back to overview]Frequency and Severity of Pneumonitis
NCT04631029 (4) [back to overview]Number of Participants Experiencing Grade 3 and 4 Adverse Events
NCT04631029 (4) [back to overview]Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide
NCT04631029 (4) [back to overview]Number of Participants With Dose Limiting Toxicities
NCT04631029 (4) [back to overview]Progression Free Survival (PFS) Rate

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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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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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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Proportion of Patients Who Relapsed Associated With the Regimen

(NCT00003875)
Timeframe: From date of transplant to date of death from any cause, assessed up to 178 months

InterventionParticipants (Count of Participants)
Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)16

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Toxicity Associated With Aldesleukin Treatment After Stem Cell Rescue

Toxicity during IL-2 therapy of any of the following per NCI Common Toxicity version 3: grade 2, 3, 4, or 5 CNS (except grade 0-3 malaise, fatigue, anxiety and depression) toxicity; grade 3, 4, or 5 non-CNS or non-hematologic toxicity; any grade 4 or 5 hematologic toxicity. (NCT00003875)
Timeframe: IL-2 administration to one month after completion of IL-2 treatment

InterventionParticipants (Count of Participants)
Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)6

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Toxicity Associated With High-dose Busulfan and Etoposide Followed by Stem Cell Rescue

Toxicity is defined as any grade 3 or grade 4 toxicity per the Bearman toxicity grading criteria following Busulfan and Etoposide high-dose chemotherapy, stem cell transplant, and the inability to recover sufficiently by day 100 to start IL-2 therapy. (NCT00003875)
Timeframe: Day -7 of transplant to 100 days post transplant

InterventionParticipants (Count of Participants)
Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)2

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Overall Survival of Patients on Busulfan and Etoposide Followed by Stem Cell Rescue and Aldesleukin

Estimated by the method of Kaplan and Meier. (NCT00003875)
Timeframe: From date of transplant to date of death from any cause, assessed up to 178 months

InterventionParticipants (Count of Participants)
Treatment (Chemo, Stem Cell Rescue, Interleukin Therapy)14

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Engraftment of HLA Identical PBSC Allografts

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

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

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Non-Relapse Mortality

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

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

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Overall Survival (OS)

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

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

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Progression Free-survival (PFS)

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

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

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Grade 3 or 4 Non-hematologic Toxicity

Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)10
Arm II (RER With CR [ABVE-PC, IFRT])153
Arm III (RER With CR [ABVE-PC])130
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])216
Arm V (RER With PD)11
Arm VI (SER [DECA, ABVE-PC, IFRT])62
Arm VII (SER [ABVE-PC, IFRT])45

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Disease Response Assessed by Modified RECIST Criteria

Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

InterventionNumber of participants (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)5
Arm II (RER With CR [ABVE-PC, IFRT])370
Arm III (RER With CR [ABVE-PC])380
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])538
Arm V (RER With PD)29
Arm VI (SER [DECA, ABVE-PC, IFRT])105
Arm VII (SER [ABVE-PC, IFRT])100

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Event-free Survival

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.89
Arm II (RER With CR [ABVE-PC, IFRT])0.87
Arm III (RER With CR [ABVE-PC])0.84
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.87
Arm V (RER With PD)0.70
Arm VI (SER [DECA, ABVE-PC, IFRT])0.79
Arm VII (SER [ABVE-PC, IFRT])0.74

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Overall Survival

Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years

InterventionProbability of survival (Number)
Arm I (Patients Off-therapy Before Callback-Induction Only)0.93
Arm II (RER With CR [ABVE-PC, IFRT])0.98
Arm III (RER With CR [ABVE-PC])0.98
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.98
Arm VI (SER [DECA, ABVE-PC, IFRT])0.96
Arm VII (SER [ABVE-PC, IFRT])0.93

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Frequency of Complete Response

"The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as complete regression of all palpable and radiographic demonstrable disease by computed tomography (CT) scan or positron emission tomography-CT (PET-CT)." (NCT00026208)
Timeframe: 5 weeks

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy31

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Overall Survival (OS)

Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. (NCT00026208)
Timeframe: 16 years

Interventionyears (Median)
Stanford V-C + Low-dose Radiotherapy10.4
Stanford V-C Only13.2

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Progression-free Survival (PFS)

Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. (NCT00026208)
Timeframe: up to 3 years

Interventionpercentage of participants (Number)
Stanford V-C + Low-dose Radiotherapy89.7
Stanford V-C Only50

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Second Hodgkin's Disease Progression

Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. (NCT00026208)
Timeframe: 16 years

InterventionParticipants (Count of Participants)
Stanford V-C + Low-dose Radiotherapy3
Stanford V-C Only1

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Survival at 5 and 10 Years

Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. (NCT00026208)
Timeframe: 5 and 10 years

,
InterventionParticipants (Count of Participants)
5 years10 years
Stanford V-C + Low-dose Radiotherapy6741
Stanford V-C Only33

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5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups

Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: 5 years from CR

Interventionpercentage of patients (Number)
Patients With HLA-matched Sibling Donor46
Patients Without HLA-matched Sibling Donors47

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5 Year Overall Survival for Autologous & Allogeneic Transplant Groups

Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: 5 years from registration

Interventionpercentage of patients (Number)
Patients With HLA-matched Sibling Donor53
Patients Without HLA-matched Sibling Donors51

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Overall Survival

Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method. (NCT00039377)
Timeframe: Duration of study (up to 10 years)

Interventionyears (Median)
Entire Cohort3.6

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Disease Free Survival

"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.~A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month." (NCT00039377)
Timeframe: Duration of treatment (up to 10 years)

Interventionyears (Median)
Entire Cohort1.7

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Number of Participants Who Achieved a BCR-ABL Response at 12 Months

"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).~Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene~MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)." (NCT00039377)
Timeframe: 12 months

Interventionparticipants (Number)
Complete Molecular ResponseMajor Molecular Response
Entire Cohort94

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Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment

Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma (NCT00049036)
Timeframe: 60 days

Interventionproportion (Number)
EPOCH + Concurrent Rituximab0.69
EPOCH Followed by Rituximab0.53

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Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy (NCT00053352)
Timeframe: Up to 126 days after the start of chemotherapy

Interventionpatients (Number)
Abdominal painAcute kidney injuryLymphocyte count decreaseIincrease in alanine aminotransferaseNeutrophil count decreaseAnemiaIncrease in aspartate aminotransferaseCatheter related infectionConstipationDehydrationEncephalopathyFebrile neutropeniaFeverHyperglycemiaHyperkalemiaHypocalcemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaSmall intestine obstructionNauseaNon-cardiac chest painOther gastrointestinal disordersOther infectionPlatelet count decreaseSyncopeVomitingWhite blood cell decreaseWound infection
Arm I3121581011111931121116151110714171

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Overall Survival (OS)

Percentage probability of being alive at 3 years following enrollment. (NCT00053352)
Timeframe: 3 Years after enrollment

InterventionPercent Probability (Number)
Arm I97.0
Arm 299.0

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Event-Free Survival (EFS)

Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients. (NCT00053352)
Timeframe: 3 Years after enrollment

InterventionPercent probability (Number)
Arm 187.0

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Days Hospitalized for Patients Who Receive Chemotherapy

Calculated to quantify the treatment cost associated with this regimen. (NCT00053352)
Timeframe: Up to 126 days after the start of chemotherapy

InterventionDays in the hospital (Mean)
Arm I14.08

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Number of Patients With Overall Survival at 2 Years.

(NCT00054327)
Timeframe: at 2 years from transplant

Interventionparticipants (Number)
Regimen A5
Regimen B-12
Regimen B-22
Regimen B-31
Regimen C5
Regimen D1

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Incidence of Recurrent Disease

Number of patients that have disease recurrence. (NCT00054327)
Timeframe: at day 100 post transplant

Interventionparticipants (Number)
Regimen A4
Regimen B-12
Regimen B-20
Regimen B-31
Regimen C2
Regimen D0

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Rates of Durable Engraftment

Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support. (NCT00054327)
Timeframe: at day 42

Interventiondays (Mean)
Regimen A17.9
Regimen B-115.75
Regimen B-213
Regimen B-318.25
Regimen C13.9
Regimen D10.5

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Toxicity as Measured by CTC v2.0

Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities. (NCT00054327)
Timeframe: at 100 days post transplant

Interventionparticipants (Number)
Regimen A0
Regimen B-10
Regimen B-21
Regimen B-32
Regimen C2
Regimen D0

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Graft-versus-host Disease (GVHD)

Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe. (NCT00054327)
Timeframe: at 100 days post transplant

,,,,,
Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Regimen A02620
Regimen B-111200
Regimen B-210101
Regimen B-310030
Regimen C11530
Regimen D00002

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Minimal Residual Disease

The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section). (NCT00057811)
Timeframe: Not Provided

Interventionpercentage of samples analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)22
Group C (Chemotherapy, Monoclonal Antibody Therapy)70

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Toxic Death

Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death. (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Toxic deathNo toxic death
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)045
Group C (Chemotherapy, Monoclonal Antibody Therapy)238

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Response Rate

Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present.. (NCT00057811)
Timeframe: Up to 5 years

Interventionpercentage of participants analyzed (Number)
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)88
Group C (Chemotherapy, Monoclonal Antibody Therapy)83

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Grade ≥ 3 Stomatitis

The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences (NCT00057811)
Timeframe: Up to 1 year

,
Interventionparticipants (Number)
Incidence of grade ≥ 3 stomatitisNo incidence of grade ≥ 3 stomatitis
Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)441
Group C (Chemotherapy, Monoclonal Antibody Therapy)634

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Duration of Response

Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. (NCT00057837)
Timeframe: Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

InterventionMonths (Median)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)6.0
PIE (Irinotecan/Cisplatin/Etoposide)6.0

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Overall Survival

Overall survival is defined as the time from randomization to death. (NCT00057837)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 years

InterventionMonths (Median)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)11.9
PIE (Irinotecan/Cisplatin/Etoposide)11.0

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Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR" (NCT00057837)
Timeframe: Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

Interventionproportion of participants (Number)
PET (Topotecan/Etoposide/Cisplatin/G-CSF)0.697
PIE (Irinotecan/Cisplatin/Etoposide)0.576

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Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.

A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis. (NCT00066742)
Timeframe: After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.

Interventionparticipants (Number)
Complete ResponseUnconfirmed Complete ResponsePartial ResponseUnconfirmed Partial ResponseNo response
Evaluable Patients With Measurable Disease0723024

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Progression-Free Survival

Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date. (NCT00066742)
Timeframe: At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.

Interventionmonths (Median)
Evaluable Patients11

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Overall Survival

Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment. (NCT00066742)
Timeframe: Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.

Interventionmonths (Median)
Evaluable Patients21

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Toxicity Associated With Chemotherapy

The number of patients that experience CTC Version 4 grade 3 or higher toxicities of any kind. (NCT00072384)
Timeframe: From date of enrollment until termination of protocol therapy assessed up to 72 weeks

InterventionPatients (Number)
Treatment (Chemotherapy, Surgery)10

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Group D Eyes - Treatment Failure Within One Year

"Each Group D eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type." (NCT00072384)
Timeframe: One year

InterventionProbability of treatment failure (Mean)
Treatment (Chemotherapy, Surgery)0.52

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Group C Eyes - Treatment Failure Within One Year

"Each Group C eye will be classified as experiencing failure within one year after start of treatment: yes or no. The method of Rosner et al. (Biometrics v. 38, 105-114, 1982) will be used to model possible dependence between eyes from the same patient. The point estimate of the probability of treatment failure is reported as the Mean measure type." (NCT00072384)
Timeframe: One year

InterventionProbability of treatment failure (Mean)
Treatment (Chemotherapy, Surgery)0.25

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Event-free Survival (EFS)

Proportion of patients event free at 1 year following enrollment. Event free survival time is computed as the time to study entry until disease relapse/progression, secondary malignancy, or death. (NCT00072384)
Timeframe: One year after study enrollment

InterventionPercentage probability (Number)
Treatment (Chemotherapy, Surgery)45.45

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Patterns of Treatment Failure vs. no Treatment Failure for Group C Eyes and Group D Eyes According to Initial Sites of Involvement

The association between the probability of experiencing treatment failure vs. no failure in a C eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. The association between the probability of experiencing treatment failure vs. no failure in a D eye and the presence of subretinal seeding (SRS), subretinal fluid (SRF), or vitreal seeding (VS) at the on study ophthalmological examination under anesthesia. (NCT00072384)
Timeframe: From the date of enrollment assessed up to 12 months

,
InterventionEyes (Number)
Treatment failure- SRS, SRF, VSTreatment failure- SRS; no SRF; no VSTreatment failure- SRS and SRF; no VSTreatment failure- SRS and VS; no SRFTreatment failure- SRF; no SRS; no VSTreatment failure- SRF and VS; no SRSTreatment failure- VS; no SRS; no SRFTreatment failure- No SRS; no VS; no SRFNo treatment failure- SRS, SRF, VSNo treatment failure- SRS; no SRF; no VSNo treatment failure- SRS and SRF; no VSNo treatment failure- SRS and VS; no SRFNo treatment failure- SRF; no SRS; no VSNo treatment failure- SRF and VS; no SRSNo treatment failure- VS; no SRS; no SRFNo treatment failure- No SRS; no VS; no SRF
Group C Eyes0000100000001011
Group D Eyes3030232021222021

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Patterns of Failure for Group C and Group D in Terms of Vitreous vs Patterns of Failure for Group C and Group D in Terms of Vitreous vs Retinal vs Both as Sites of Recurrence

Sites of disease recurrence for Group C and Group D eyes where treatment failure was detected (NCT00072384)
Timeframe: From the date of enrollment assessed up to 36 months

,
InterventionEyes (Number)
Retinal seeding and vitreal seedingRetinal seeding but no vitreal seedingVitreal seeding but no retinal seedingNeither retinal seeding nor vitreal seeding
Group C Eyes0100
Group D Eyes1714

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Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0

Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25% (NCT00073918)
Timeframe: From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years

Interventionevents (Number)
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)9

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5 Year Overall Survival

Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis. (NCT00073918)
Timeframe: Up to 15 years

Interventionpercentage of participants (Number)
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)72

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Progression-free Survival

Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy. (NCT00073918)
Timeframe: At year 3

Interventionpercentage of participants (Number)
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)56

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Response Rate

Response rates will be estimated as the percentage of patients (NCT00073918)
Timeframe: From date of transplant through date of relapse/progression or death, assessed up to 15 years

Interventionpercentage of participants (Number)
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)41.4

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Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.

Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions. (NCT00074165)
Timeframe: 2 years

InterventionParticipants (Number)
Rituximab and Carboplatin1

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Overall Survival

Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored. (NCT00079040)
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 1 year

Interventionmonths (Median)
Cisplatin, Etoposide, Bevacizumab10.9

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Percentage of Participants Alive and Progression-free (PF) at 6 Months

Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate. (NCT00079040)
Timeframe: 6 months

InterventionPercentage of Participants (Mean)
Cisplatin, Etoposide, Bevacizumab30.2

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Best Objective Response

Number of patients with complete or partial response by RECIST criteria. (NCT00079040)
Timeframe: Assessed every 6 weeks

InterventionPatients Responding (Number)
Cisplatin, Etoposide, Bevacizumab40

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Rate of Minimal Residual Disease (MRD) < 0.01%

Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)

InterventionProportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.195
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.295

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Pharmacokinetics

Mean trough serum concentration measured before final dose of epratuzumab. (NCT00098839)
Timeframe: Up to day 36

Interventionug/mL (Mean)
Twice Weekly Dosing Schedule501

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Event-free Survival Rate

Proportion of patients who were event free at 4 months (NCT00098839)
Timeframe: At 4 months after enrollment

InterventionProportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.604
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.640

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Remission Re-induction (CR2) Rate

The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count. (NCT00098839)
Timeframe: At the end of Block 1 of re-induction therapy (day 36)

Interventionproportion of participants (Number)
Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly.646
Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly.660

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Event-free Survival (EFS)

"EFS is defined as time from randomisation to the first of: death, detection of local recurrence or metastasis, progression of metastatic disease, or detection of a secondary malignancy.~EFS will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Follow up per participant will be assessed for up to 10 years. The 3 year EFS is provided as a summary." (NCT00134030)
Timeframe: From date of randomization to date of the event.

InterventionPercentage EFS (Number)
MAP-GR74
MAPifn77
MAP-PR55
MAPIE53

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Percentage of Patients With Overall Survival

"Overall survival is time from randomization until death from any cause.~Will be assessed using the logrank test and expressed using hazard ratios with appropriate confidence intervals. Participants will be assessed for up to 10 years. 5 year overall survival is provided as a summary." (NCT00134030)
Timeframe: From date of randomization to date of death.

InterventionPercentage of participants (Number)
MAP-GR84
MAPifn84
MAP-PR68
MAPIE68

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Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Percentages of patients experiencing grade 3 and 4 adverse events. These will be compared using chi-square tests or Fisher's exact tests where appropriate. (NCT00134030)
Timeframe: Adverse events are assessed for up to 10 years per participant.

InterventionParticipants (Count of Participants)
MAP-GR348
MAPifn340
MAP-PR287
MAPIE281

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Overall Survival (OS)

OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given. (NCT00186875)
Timeframe: 2 years after last patient completes therapy (approximately 4 years after enrollment)

Interventionprobability (Mean)
Standard Risk0.654
High Risk0.357

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Response Rate

"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology." (NCT00186875)
Timeframe: End of re-induction Block C (approximately 1 month after the start of therapy)

,
Interventionproportion of participants (Number)
Complete remissionFailure to reach complete remission
High Risk0.7860.214
Standard Risk0.8460.154

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Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)

The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block Block C therapy (Day 46)

,,
InterventionParticipants (Count of Participants)
Negative <0.01%Positive ≥0.01%
High Risk18
Standard Risk119
TOTXV Participants390102

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Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)

The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block B therapy (Day 19)

,,
InterventionParticipants (Count of Participants)
Negative <0.01%Positive ≥0.01%
High Risk210
Standard Risk1111
TOTXV Participants191297

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Change in Cognitive Functioning

The Early Learning Composite was assessed with Mullen Scales of Early Learning, a measure of developmental functioning appropriate for use with children from birth through age 5. It is an examiner-administered instrument that uses toys, games, pictures, and other objects to elicit information about a child's language, fine and gross motor skills, and overall early learning capabilities. Raw scores are converted to an age-normed standard score (normative mean = 100, SD = 15) for the overall Early Learning Composite. This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range. (NCT00186888)
Timeframe: Baseline (at study entry) and at ages 6 months, 1 year, 2 years, 3 years and 5 years

Interventionunits on a scale (Mean)
Baseline91.61
6 Months90.96
1 Year95.91
2 Years88.40
3 Years82.12
5 Years86.00

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Number of Participants With Change in Size of Pineal Gland

The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in pineal gland size is reported here. (NCT00186888)
Timeframe: From diagnosis through 6 years after last patient enrollment

InterventionParticipants (Count of Participants)
Prominent or mildly enlarged pineal glandsPineal growth over timeNo change in pineal gland size
Participants With Bilateral Retinoblastoma12823

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Assessment of School Readiness

The Bracken Basic Concepts Scale was used to assess school readiness. It is an examiner-administered measure that assesses per-academic skills including letter and number recognition, shapes, colors, and understanding of sizes and comparisons. Raw scores are converted into age-normed scaled scores (normative mean = 10, SD = 3) for the School Readiness Composite. Higher scores are indicative of stronger pre-academic skills, with scores from 7 to 13 within the Average range. (NCT00186888)
Timeframe: Patients were assessed at 5 years of age

Interventionunits on a scale (Mean)
5 Years8.96

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Mean Primary Visual Cortex Function: Cluster Size

"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neuology, London).~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time." (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment

Interventionnumber activated voxels (negative BOLD) (Mean)
Stratum A2372
Stratum B1080
Stratum C2105

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Change in Parent Report of Social-Emotional Factors

This outcome was measured using the Ages and Stages Questionnaire which is a parent-completed measure of a child's social-emotional functioning. Raw scores are calculated and compared to cut-off points by age (6 months = 45; 1 year = 48; 2 years = 50; 3 years = 59; 5 years =70). Higher scores are indicative of more problems with scores above the cut-off indicating significant concerns warranting additional follow-up. Possible scores range from 0 to 200+, depending on the number of items administered, which varies by the age of the child (19 to 33 items). However, the primary use of this tool is as a screener. Thus, typically, scores are interpreted as they compare to the identified cut-offs, with children who score above the cut-off referred for further evaluation. This measure was given at all time points. (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years

Interventionunits on a scale (Mean)
Baseline40
6 Months19.42
1 Year26.28
2 Years29.67
3 Years40.61
5 Years39.93

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Change in Distortion Product Otoacoustic Emissions (DPOAEs)

For DP_amplitude to be considered valid, a baseline DP_SNR (Distortion Product for Signal-to-noise ratio) for each frequency (1000-8000 Hz) and for each ear (left and right) must be = 6 dB. Any ear with invalid amplitude at baseline for each frequency should be excluded. The DPOAEs amplitude levels were averaged across the right and left ears at each frequency in the patients exhibiting valid DPOAE amplitudes in both ears, resulting in mean DPOAE levels. Subsequently, comparisons between baseline and most recent evaluation (collapsed across ears) for each frequency were made to evaluate if a significant decrease in DPOAE amplitude exists between the two time points. (NCT00186888)
Timeframe: From Diagnosis through 5 years after completion of therapy

,,
InterventiondB (Mean)
1000 Hz1400 Hz2000 Hz2800 Hz4000 Hz6000 Hz8000 Hz
Additional Evaluation4.58.211.08.43.45.7-9.9
Baseline17.716.615.111.615.313.35.0
Interim Evaluation5.59.413.012.211.312.9-2.0

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Relationship Between Topotecan Clearance (CL) and ABCG2/B1 Genotype in Stratum B Participants.

Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol. (NCT00186888)
Timeframe: Courses 1, 2, 5, and 8

InterventionLiters/hour/m^2 (Median)
Stratum B18.8

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Ocular Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification

"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma . The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A-Early Disease0.857
Stratum A-Advanced Disease0.500
Stratum B-Early Disease1.0
Stratum B-Advanced Disease0.719

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Change in Relevant Daily Living Skills

The Adaptive Behavior composite was measured using the Vineland Scales of Adaptive Behavior (VABS) which is an examiner-administered semi-structured interview that assesses adaptive functioning from birth through adulthood. Subscales including motor skills, communication, socialization, and daily living skills combine into an overall adaptive behavior composite which is an age-normed standard score (normative mean = 100, SD = 15). This measure was given at all time points. Higher scores are indicative of better functioning, with scores from 85-115 in the average range. (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years

Interventionunits on a scale (Mean)
Baseline97.48
6 Months104.73
1 Year106.06
2 Years94.22
3 Years96.45
5 Years93.03

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Change in Parenting Stress Index (PSI)

The PSI is a commonly used measure of parenting stress. In 101 questions, the PSI delineates between stress as a function of child characteristics (e.g., adaptability, demandingness, mood; Child Domain) and stress as a function of parent characteristics (e.g., depression, sense of competence, social isolation; Parent Domain), as well as an overall stress score (Total Stress). Raw scores are calculated (normative means: Child Doman = 98.4; Parent Domain = 122.7; Total Stress Score = 221.1). This measure was given at all time points. Scores range from 131-320 for Total Stress, 69-188 for Parent Domain, and 50-145 for Child Domain, with higher scores indicative of greater stress (Total: >260; Parent: >153, Child: >122). (NCT00186888)
Timeframe: Baseline (at study entry), 6 months, 1 year, 2 years, 3 years, and 5 years

,,,,,
Interventionunits on a scale (Mean)
Child DomainParent DomainOverall Total Stress
1 Year93.27105.84200.51
2 Years92.77105.84198.61
3 Years94.60105.92200.23
5 Years92.49102.74194.68
6 Months93.08101.56194.84
Baseline96.76109.38207.25

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Event-free Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification

"To describe the 5-year event-free survival of the eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A-Early Disease0.839
Stratum A-Advanced Disease0.667
Stratum B-Early Disease1.0
Stratum B-Advanced Disease0.743

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Event-free Survival of Eyes in Stratum B Patients Responding to Window Treatment

"To estimate the 5-year event-free survival (EFS) of eyes of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year EFS." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B0.763

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Event-free Survival of Eyes of Stratum B Patients

"To estimate the 5-year event-free survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Event-free survival of eye will be defined per eye as the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) or to last follow-up date for eyes without events. Event-free survival of eye will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B1.0

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Event-free Survival of Stratum A Patients

"To estimate the 5-year event-free survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A0.688

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Event-free Survival of Stratum B Patients Responding to Window Treatment

"To estimate the 5-year event-free (EFS) survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Event-free survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of first event (an event includes external beam radiation or enucleation) of advanced stage eyes, time to first event will be used for the analysis. Event-free survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B0.667

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Event-free Survival Per Eye in Stratum A and Stratum B Patients Based on AJCC Classification

"To describe the 5-year event-free survival of eyes outcome of intraocular retinoblastoma with respect to the new classification of the American Joint Committee on Cancer (AJCC).~For AJCC staging, the patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A-Early Disease0.857
Stratum A-Advanced Disease0.500
Stratum B-Early Disease1.0
Stratum B-Advanced Disease0.719

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Ocular Survival of Stratum B Patients Responding to Window Treatment

"To estimate the 5-year ocular survival of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival" (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B0.667

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Ocular Survival of Stratum A Patients

"To estimate the 5-year ocular survival of patients with early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive focal treatments.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A0.688

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Ocular Survival of Eyes of Stratum B Patients

"To estimate the 5-year ocular survival of early stage eyes (R-E I-III) of patients with contralateral advanced disease treated with vincristine and topotecan.~Ocular survival will be defined per patient as follows: for patients with one advanced stage eye, the time interval from date on study to date of enucleation of advanced stage eye or date of last follow-up, for patients with two advanced stage eyes, the time to the first enucleation will be used for analysis. Ocular survival will be estimated using the method of Kaplan and Meier." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B1.0

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Ocular Survival of Eyes in Stratum B Patients Responding to Window Treatment

"To estimate the 5-year ocular survival of eye of bilateral disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the vincristine/topotecan window, with alternating cycles of vincristine and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive focal treatments.~Ocular survival of eye will be defined per eye as the time interval from date on study to date of enucleation or date of last follow-up. Ocular survival of eye will be estimated using the method of Kaplan and Meier. Standard error is 5-year ocular survival." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum B0.763

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Relationship Between Topotecan Clearance (CL) and CYP3A4/5 Genotype in Stratum B Participants.

Blood samples for pharmacokinetic studies were collected at 0 hour (pre-dose), 5 minutes, 1.5 and 2.5 hours after the end of topotecan dose on Course 1 Day 1, Course 2 Day 1, and if further studies were needed, Course 5 Day 1 and Course 8 Day 1. A blood sample for pharmacogenetic studies was collected during the course of therapy on protocol. (NCT00186888)
Timeframe: Courses 1, 2, 5, and 8

InterventionLiters/hour/m^2 (Median)
Stratum B18.8

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Mean Primary Visual Cortex Function: Maximum T-value

"Functional magnetic resonance imagining (fMRI) was used to investigate primary visual cortex (V1) response to visual stimulation in 105 children being treated for intraocular retinoblastoma. Primary visual cortex activity was assessed in each subject using blood oxygenation level-dependent (BOLD) signal. The BOLD signal was analyzed via a general linear model using Statistical Parametric Mapping software (SPM, Wellcome Institute of Neurology, London). The maximum t-statistic in activated cluster (negative BOLD) is provided.~Voxel volume/peak BOLD response is a measurement of the volume of activation of the cortex. There is no known association with visual outcome at this time." (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment

InterventionMaximum t-statistic (negative BOLD) (Mean)
Stratum A7.9
Stratum B6.2
Stratum C8.8

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Ocular Survival of Eyes in Stratum A and Stratum B Patients Based on IC Classification

"To describe the 5-year ocular survival of eyes outcome of intraocular retinoblastoma with respect to the new International Classification (IC) for Intraocular Retinoblastoma and the AJCC.~Patients were re-classified into 2 groups of early (IC groups A and B) and advanced (IC groups C, D, and E) retinoblastoma. Analysis was done at eye level since each eye in the same patient could be a different group. Patients from stratum A and B were analyzed separately.~Three eyes (2 patients) in stratum B received external beam radiation therapy (EBRT) and were also coincident with enucleation surgery, so their event status was not changed. Although the 3 eyes had shorter EFS interval because EBRT occurred (less than 2 years) before the surgery, it did not change the 5-year survival probability." (NCT00186888)
Timeframe: From date on-study to an event or last follow-up

Interventionprobability (Number)
Stratum A-Early Disease0.839
Stratum A-Advanced Disease0.667
Stratum B-Early Disease1.0
Stratum B-Advanced Disease0.743

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Stratum B Response to Window Therapy

The primary outcome is to estimate the proportion of stratum B patients responding to 2 courses of window therapy consisting of vincristine and topotecan. Complete Response is the complete regression of all apparent tumor masses in the funduscopic examination and by MRI and ultrasound (US). Partial Response is defined as greater than 50% (but less than 100%) reduction of the tumor masses in the funduscopic examination and by US and MRI, without the appearance of any new lesions. The response must persist for at least 4 weeks. Stratum A and C did not receive window therapy. (NCT00186888)
Timeframe: Six weeks post window therapy

InterventionParticipants (Number)
Partial responseProgressive Disease or New LesionFailure due to Toxicity
Stratum B2421

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Stratum B Response Rate of Early Stage Eyes to Window Therapy

To estimate the proportion of early stage eyes defined as Reese-Ellsworth Group I, II, or III eyes, that responded to 2 courses of window therapy which consisted of vincristine and topotecan (NCT00186888)
Timeframe: Six weeks post window therapy.

InterventionParticipants (Number)
Partial responseProgressive Disease / New lesionFailure due to Toxicity
Stratum B1101

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Number of Participants With Development of Pineal Cysts

The MRI reports from bilateral patients were reviewed and data abstracted regarding pineal gland measurement and information about pineal cysts. The number of participants with change in primary visual cortex function from diagnosis through 6 years after last patient enrollment is reported here. (NCT00186888)
Timeframe: At diagnosis through 6 years after last patient enrollment

InterventionParticipants (Count of Participants)
Developed new solitary cyst(s)Developed multiple new cystsGrowth of pineal cystDecrease in size (resolution) of pineal cystNo change
Participants With Bilateral Retinoblastoma12155111

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Overall Survival

Overall survival is the duration from enrollment to death from any cause. For patients who are alive, overall survival is censored at the last contact. (NCT00191139)
Timeframe: baseline to date of death from any cause up to 2057 days

Interventiondays (Median)
Gemcitabine492.5
Gemcitabine Plus Docetaxel899.0

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Progression-Free Survival

Defined as the time from randomization into consolidation treatment to the first date of documented disease progression or death. Progression-free survival time was censored at the date of the last follow-up visit at which disease was assessed for patients who were still alive and who had not progressed. (NCT00191139)
Timeframe: baseline to measured progressive disease up to 2057 days

Interventiondays (Median)
Gemcitabine162.5
Gemcitabine Plus Docetaxel408.0

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Lung Cancer Symptom Scale (LCSS) Assessment Post-randomization

LCSS measures physical & functional dimensions. The patient scale contains 9 items, 3 summation & 6 symptom items. Each item is marked on a visual analog scale (0=low; 100=high). The mean of the 6 symptoms is used to calculate the average symptom burden index (ASBI). Improved=mean ASBI assessments from any 2 consecutive improved post-randomization assessments was at least 0.5 standard deviation (SD) below pre-randomization ASBI; worse=mean ASBI from any 2 consecutive post-randomization assessments was at least 0.5 SD above pre-randomization ASBI; stable=criteria for improved/worse not met. (NCT00191139)
Timeframe: baseline to 3 months after last dose of study treatment (three 21-day cycles)

,
Interventionparticipants (Number)
ImprovementStableWorse
Gemcitabine8102
Gemcitabine Plus Docetaxel598

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2-Year Survival

Percentage of participants alive at 2 years. (NCT00191139)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine40.6
Gemcitabine Plus Docetaxel55.7

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Number of Patients With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) =30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) =20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. The total number of CRs plus PRs equals overall response rate (ORR). (NCT00191139)
Timeframe: randomization and every 3 months up to 2 years of post-study followup

Interventionparticipants (Number)
Gemcitabine24
Gemcitabine Plus Docetaxel27

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Overall Survival

Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.99

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Intensive Therapy Free Survival (ITFS).

Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.89

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Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).

Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.49

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Event Free Survival (EFS)

Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.79

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Complications Associated With Radical Adrenalectomy and RLND

Any patient who dies because of surgery or has a grade 3 or 4 toxicity possibly, probably or likely related to surgery will be considered as having experienced a surgical complication. The complication rate is estimated as the proportion of evaluable patients that have a complication. (NCT00304070)
Timeframe: Up to 1 month after surgery

Interventionparticipants (Number)
All Patients1

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Frequency of Tumor Spillage at the Time of Tumor Resection

The number of eligible patients who have surgical resection of the primary tumor and have tumor spillage at the time of resection. (NCT00304070)
Timeframe: Up to one year or while on protocol therapy, whichever is less

InterventionParticipants (Count of Participants)
All Patients15

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Incidence and Type of Germline TP53 Mutations in Non-Brazilian Children and Children From Southern Brazil by Deoxyribonucleic Acid (DNA) Sequencing and Affymetrix Gene Chip Analysis.

The proportion of patients in each subpopulation are compared.This test is dependent on the number of patients from whom blood can be obtained as well as the frequency of the relevant mutation in each group. (NCT00304070)
Timeframe: At study enrollment

Interventionparticipants (Number)
C229R mutation in p53 in Patients from BrazilC229R mutation in Patients not from BrazilE180K mutation in p53 in Patients from BrazilE180K mutation in Patients not from BrazilG245C mutation in p53 in Patients from BrazilG245C mutation in Patients not from BrazilI254T mutation in p53 in Patients from BrazilI254T mutation in Patients not from BrazilL265Q mutation in p53 in Patients from BrazilL265Q mutation in Patients not from BrazilP47S mutation in p53 in Patients from BrazilP47S mutation in Patients not from BrazilQ52fs mutation in p53 in Patients from BrazilQ52fs mutation in Patients not from BrazilR158L mutation in Patients from BrazilR158L mutation in Patients not from BrazilG245S mutation in Patients from BrazilG245S mutation in Patients not from BrazilR213P mutation in p53 in Patients from BrazilR213P mutation in Patients not from BrazilR248L mutation in Patients from BrazilR248L mutation in Patients not from BrazilR282W mutation in p53 in Patients from BrazilR282W mutation in p53 in Patients not from BrazilR283H mutation in p53 in Patients from BrazilR283H mutation in p53 in Patients not from BrazilR337H mutation in p53 in Patients from BrazilR337H mutation in p53 in Patients not from BrazilR342X mutation in p53 in Patients from BrazilR342X mutation in p53 in Patients not from BrazilT125T c375G>A muation in p53 in Pts from BrazilT125T c375G>A mutation in p53 in pts not from BrazT125T splice in DBD in pts from BrazilT125T splice in DBD in pts not from Brazilwild type p53 in Patients from Brazilwild type p53 in Patients not from Brazil
All Patients020101100101010101010101031200011101116

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Molecular Alterations and Embryonal Markers in Children With ACT - A43 del33bp Mutation of (Beta)-Catenin.

The number of eligible patients who have A43 del33bp mutation of (beta)-catenin. (NCT00304070)
Timeframe: Patients who had surgery at time of enrollment.

InterventionParticipants (Count of Participants)
children with ACT - wild type (beta)-cateninA43 del33bp mutation of (beta)-catenin
All Patients511

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Frequency of Lymph Node Involvement by Imaging.

The number eligible patients who have lymph node involvement by imaging at study enrollment. (NCT00304070)
Timeframe: At study enrollment

InterventionParticipants (Count of Participants)
All Patients71

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Five Year Event-free Survival (EFS)

The model used for comparison will be an exponential model with a constant failure rate of 0.053 (stratum I), 0.347 (stratum II), 0.602 (stratum III and IV) per year for the first two years and 0 after that. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model (Woolson, 1981) of size 0.05 will be used to assess whether the data are consistent with the target models. Since this test has independent increments, the method of Lan and DeMets will be used to derive the p-values for testing procedure. (NCT00304070)
Timeframe: Up to five years after enrollment

InterventionEstimated probability five year EFS (Number)
Stratum 10.86
Stratum 20.53
Stratum 30.51

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Toxicity Associated With Chemotherapy Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

The proportion of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher anemia at any time during protocol therapy (NCT00304070)
Timeframe: Up to 182 Days After Enrollment

Interventionparticipants (Number)
Incidence of Abdominal InfectionIncidence of Abdominal PainIncidence of AcidosisActivated Partial Thromboplastin Time ProlongedIncidence of Adrenal InsufficiencyIncidence of Alanine Aminotransferase IncreasedIncidence of Allergic ReactionIncidence of AnemiaIncidence of AnorexiaIncidence of Aspartate Aminotransferase IncreasedIncidence of Blood Bilirubin IncreasedIncidence of Cardiac Disorders - Other, SpecifyIncidence of Catheter Related InfectionIncidence of ColitisIncidence of ConfusionIncidence of DehydrationIncidence of Depressed Level of ConsciousnessIncidence of DiarrheaIncidence of DyspneaIncidence of Enterocolitis InfectiousIncidence of EsophagitisIncidence of Febrile NeutropeniaIncidence of FeverIncidence of Gastrointestinal Disorders - Other, SIncidence of Generalized Muscle WeaknessIncidence of GGT IncreasedIncidence of Hearing ImpairedIncidence of Heart FailureIncidence of HyperglycemiaIncidence of HyperkalemiaIncidence of HypertensionIncidence of HypocalcemiaIncidence of HypoglycemiaIncidence of HypokalemiaIncidence of HypomagnesemiaIncidence of HyponatremiaIncidence of HypophosphatemiaIncidence of HypotensionIncidence of HypoxiaIncidence of Infections and Infestations - Other,Incidence of INR IncreasedIncidence of Left Ventricular Systolic DysfunctionIncidence of Lung InfectionIncidence of Lymphocyte Count DecreasedToxicity Associated with MitotaneIncidence of Mucositis OralIncidence of NauseaIncidence of Neutrophil Count DecreasedIncidence of Obstruction GastricIncidence of PainIncidence of Peripheral Motor NeuropathyIncidence of Peripheral Sensory NeuropathyIncidence of PharyngitisIncidence of Platelet Count DecreasedIncidence of PneumonitisIncidence of Premature MenopauseIncidence of Rash Maculo-papularIncidence of SepsisIncidence of Skin InfectionIncidence of Sore ThroatIncidence of Upper Respiratory InfectionIncidence of Urinary Tract InfectionIncidence of Vascular Access ComplicationIncidence of Ventricular ArrhythmiaIncidence of VomitingIncidence of White Blood Cell DecreasedIncidence of Wound Infection
Stratum 3121152122721231131121216121161331319274237121246520111112031121111215161

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Overall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. (NCT00334815)
Timeframe: Every week, up to 4 years

InterventionMonths (Median)
Low Risk Patient Stratum46
High Risk Patient Stratum17

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Progression-free Survival

From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact. (NCT00334815)
Timeframe: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

InterventionMonths (Median)
Low Risk Patient Stratum38
High Risk Patient Stratum15

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Response Rate (Confirmed or Unconfirmed Partial Response)

Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. (NCT00334815)
Timeframe: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Interventionpercentage of participants (Number)
Low Risk Patient Stratum64
High Risk Patient Stratum70

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Adverse Events

Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00334815)
Timeframe: Up to one year

,
InterventionParticipants (Number)
Acidosis (metabolic or respiratory)Arthritis (non-septic)Calcium, serum-low (hypocalcemia)Carbon monoxide diffusion capacity (DL(co))CreatinineDehydrationDyspnea (shortness of breath)EsophagitisFEV(1)Febrile neutropeniaGlucose, serum-high (hyperglycemia)HemoglobinHemorrhage, Respiratory tract NOSHemorrhage, GI - Peritoneal cavityHemorrhage, pulmonary/upper respiratory - LungHypotensionHypoxiaINR (of prothrombin time)Inf (clin/microbio) w/Gr 3-4 neuts - NoseInf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gumsInf (clin/microbio) w/Gr 3-4 neuts - UTIInf (clin/microbio) w/Gr 3-4 neuts - Upper airwayInf w/normal ANC or Gr 1-2 neutrophils - BloodInf w/normal ANC or Gr 1-2 neutrophils - LungLeukocytes (total WBC)LymphopeniaMuscle weakness, not d/t neuropathy - body/generalNauseaNeutrophils/granulocytes (ANC/AGC)Pain - Chest wallPain - Chest/thorax NOSPain - Head/headachePain - JointPain - NeckPain - Throat/pharynx/larynxPlateletsPneumonitis/pulmonary infiltratesPotassium, serum-low (hypokalemia)Pulmonary/Upper Respiratory-Other (Specify)Rash/desquamationRash: dermatitis associated w/radiationSodium, serum-low (hyponatremia)Weight loss
Concurrent Chemotherapy and Radiotherapy00011112131200010111101162121011101121301110
Consolidation Therapy With Docetaxel and Bevacizumab.1110001000021110100001000310000010002110001

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Pathological Features Present At Diagnosis - Tumor Involving the Optic Nerve Posterior to the Lamina Cribrosa (LC) as an Independent Finding

Proportion of patients with tumor involving the optic nerve posterior to the lamina cribrosa as an independent. (NCT00335738)
Timeframe: At enrollment

InterventionProportion of patients with LC (Number)
All Patients0.16

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Toxicity As Assessed By the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Number of patients assigned chemotherapy who experienced grade 3 or higher CTC AE toxicity. (NCT00335738)
Timeframe: During planned six cycles of chemotherapy

Interventionparticipants (Number)
Group 1 (Identified by Central Review as High Risk)19

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Pathological Features Present At Diagnosis - Anterior Chamber Seeding (ACS)

Proportion of patients who had anterior chamber seeding at enrollment. (NCT00335738)
Timeframe: At enrollment

InterventionProportion of patients with ACS (Number)
All Patients0.045

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Pathological Features Present At Diagnosis - Ciliary Body Infiltration (CBI)

Proportion of patients who had ciliary body infiltration at enrollment. (NCT00335738)
Timeframe: At Enrollment

InterventionProportion of patients with CBI (Number)
All Patients0.019

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Pathological Features Present At Diagnosis - Iris Infiltration (II)

Proportion of patients who had iris infiltration at enrollment. (NCT00335738)
Timeframe: At enrollment

InterventionProportion of patients with II (Number)
All Patients0.029

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Pathological Features Present At Diagnosis - Posterior Uveal Invasion (PVI)

Proportion of patients who had posterior uveal invasion at enrollment. (NCT00335738)
Timeframe: At enrollment

InterventionProportion of patients with PVI (Number)
All Patients0.24

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Pathological Features Present at Diagnosis - Scleral Invasion (SI)

Proportion of patients that had scleral invasion at enrollment. (NCT00335738)
Timeframe: At enrollment

InterventionProportion of patients with SI (Number)
All Patients0.016

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Event-free Survival (EFS)

EFS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone. (NCT00335738)
Timeframe: At 2 years

InterventionEstimated Probability (Number)
Group 1 (Identified by Central Review as High Risk)0.9394
Group 2 (Identified by Central Review as Not High Risk)0.9953

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Overall Survival (OS)

OS distributions will be estimated by the Kaplan-Meier method for patients with high risk features according to central review and treated with adjuvant chemotherapy and separately for subjects with central review recommendation of enucleation alone. (NCT00335738)
Timeframe: At 2 Years

InterventionEstimated Probability (Number)
Group 1 (Identified by Central Review as High Risk)0.9628
Group 2 (Identified by Central Review as Not High Risk)1

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Median/Range of Patients for Total Quality of Life (QOL) Score, Intelligence Quotient (IQ) and Processing Speed Index (PSI).

"Three tools are used to assess intelligence (IQ) depending on age. The range of IQ scores is 40-160 (mean=100, SD=15); range for the Processing Speed Index (PSI)=45-155. Higher scores represent better functioning. (1) Wechsler Preschool and Primary Scale of Intelligence-4th Edition (WPPSI-IV) is used for ages 2.5 to 6 years. Bug Search and Cancellation subtests are summed to calculate PSI. (2) Wechsler Intelligence Scales for Children-5th Edition (WISC-V) is used for ages 6 - 16 years. Symbol Search and Coding subtests are summed to calculate PSI. (3) Wechsler Adult Intelligence Scales-4th Edition (WAIS-IV) is used for ages 16 and older. Symbol Search and Coding subtests are summed to calculate PSI.~The Pediatric Quality of Life Inventory Version 4 (PedsQL) measures health-related quality of life (QOL). Parents complete the measure for children ages 2-17, and patients > 18 complete a self-report version. Total scores range from 0-100, with higher scores representing better QOL." (NCT00336024)
Timeframe: 60 months (+/- 3 months)

,
Interventionscores on a scale (Median)
Total Quality of Life ScoreIntelligence QuotientProcessing Speed Index
Arm I (Patients Treated Without Methotrexate (MTX))60.577.082.0
Arm II (Patients Treated With MTX)56.578.589.0

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Rates of Gastrointestinal Toxicities

Rates of gastrointestinal toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
GI Tox Induction Cycle INo GI Tox Induction Cycle IGI Tox Induction Cycle IINo GI Tox Induction Cycle IIGI Tox Induction Cycle IIINo GI Tox Induction Cycle IIIGI Tox Consolidation Cycle INo GI Tox Consolidation Cycle IGI Tox Consolidation Cycle IINo GI Tox Consolidation Phase IIGI Tox Consolidation Cycle IIINo GI Tox Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))8314354351128732534
Arm II (Patients Treated With MTX)1226102883014241028632

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Number of Participants With Chronic Central Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Central Hypothyroidism is defined as Free T4 level less than Institutional Normal with TSH less than or equal to Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Percentage of Participants With Event Free Survival (EFS)

EFS was defined as time from enrollment to the occurrence of first event (disease progression/relapse, secondary malignancy, death from any cause) or date of last contact for patients who are event-free. The percentage of participants with EFS and 90% confidence interval were provided. The difference in incidence for the two treatment regimens were compared using a one-sided log-rank test with a significance level of 0.1. (NCT00336024)
Timeframe: Baseline to up to 5 years

Interventionpercentage of participants with EFS (Number)
Arm I (Patients Treated Without Methotrexate (MTX))43.6
Arm II (Patients Treated With MTX)54.9

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Number of Participants With Chronic Diabetes Insipidus

"The number of patients who had Diabetes Insipidus and on DDAVP will be reported for this analysis due to small numbers.." (NCT00336024)
Timeframe: Beginning of off-treatment to up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)1

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Number of Participants With Chronic Low Somatomedin C

Low Somatomedin C is defined as patients with somatomedin C value less than institutional normal. As numbers are too small, descriptive statistics such as number will be reported for this analysis. Growth hormone function was assessed as per ACNS0334 Endocrine Guidelines. Low Somatomedin C levels are defined at each institution by the laboratory standards where the blood tests are run. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))2
Arm II (Patients Treated With MTX)5

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Number of Participants With Chronic Primary Hypothyroidism/Subclinical Compensatory HypothyroidismHypothyroidism/Subclinical Compensatory Hypothyroidism

"Thyroid function was assessed as per ACNS0334 Endocrine Guidelines. Normal and Abnormal are defined at each institution by the laboratory standards where the blood tests are run. Primary Hypothyroidism/Subclinical Compensatory Hypothyroidism is defined as patients with Free T4 level less than Institutional Normal or equal to Institutional Normal with TSH level greater than Institutional Normal." (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))3
Arm II (Patients Treated With MTX)5

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Number of Participants With Secondary Malignancies

The number of patients who had secondary malignancy will be reported for this analysis due to small numbers. (NCT00336024)
Timeframe: Off-treatment up to 9 years

InterventionParticipants (Count of Participants)
Arm I (Patients Treated Without Methotrexate (MTX))1
Arm II (Patients Treated With MTX)0

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Percentage of Participants With Any Acute Adverse Events

Event is defined as the first occurrence of any acute toxicity. Estimates will be obtained using life-table methods. Patients who have progression or recurrence of disease will be censored in this analysis. Difference in incidence for the two treatment regimens will be compared using log-rank test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

Interventionpercentage of participants (Number)
Arm I (Patients Treated Without Methotrexate (MTX))97.4
Arm II (Patients Treated With MTX)97.2

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Rates of Nutritional Toxicities

Rates of nutritional toxicities reported as Adverse Events during therapy for each cycle will be summarized using standard descriptive methods (such as number of patients). The difference in number of patients with nutritional toxicities between the two treatment regimens will be compared using a Chi-square test. (NCT00336024)
Timeframe: Beginning of treatment to the end of consolidation

,
InterventionParticipants (Count of Participants)
Nutritional Disorders Induction Cycle INo Nutritional Disorders Induction Cycle INutritional Disorders Induction Cycle IINo Nutritional Disorders Induction Cycle IINutritional Disorders Induction Cycle IIINo Nutritional Disorders Induction Cycle IIINutritional Disorders Consolidation Cycle INo Nutritional Disorders Consolidation Cycle INutritional Disorders Consolidation Cycle IINo Nutritional Disorders Consolidation Cycle IINutritional Disorders Consolidation Cycle IIINo Nutritional Disorders Consolidation Cycle III
Arm I (Patients Treated Without Methotrexate (MTX))1029132673212279301029
Arm II (Patients Treated With MTX)172113251226830533533

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Overall Participant Survival (OS)

Survival status was assessed 5 years after transplant. (NCT00349778)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
High-Dose Sequential Therapy52

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Number of Participants With Pulmonary Toxicity

Pulmonary toxicity was assessed as the incidence of interstitial pneumonitis. (NCT00349778)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
High-Dose Sequential Therapy32

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Number of Participants That Relapse After Autologous Transplantation

Relapse was measured as the number of patients who relapse after high-dose sequential therapy then autologous transplantation (NCT00349778)
Timeframe: 5 years

InterventionParticipants (Count of Participants)
High-Dose Sequential Therapy66

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Response

Anti tumor activity as assessed by computed tomography of neck/chest/abdomen/pelvis, positron emission tomography scan and/or gallium scan. Assessed by physical examination appropriate imaging studies. Bone marrow aspirate/biopsy must be normal and any macroscopic nodules in any organs detectable on imaging techniques should no longer be present. Gallium scans must be negative if initially positive. (NCT00354107)
Timeframe: Week 4

Interventionpercent (Number)
Treatment (Monoclonal Antibody Therapy, Chemotherapy)50

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Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program

Mean and standard deviation of half-life of elimination. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. (NCT00369317)
Timeframe: Days 1, 2, 8, and 9 of induction II

InterventionMean minutes (Mean)
Treatment (Combination Chemotherapy)306.156034

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Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program

Mean and standard deviation of peak plasma concentration. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. (NCT00369317)
Timeframe: Days 1, 2, 8, and 9 of induction II

InterventionMean micromolar (Mean)
Treatment (Combination Chemotherapy)32.69931

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Event-free Survival (EFS) at 3 Years

(NCT00369317)
Timeframe: Time from study entry to induction failure, relapse, or death assessed at 3 years.

Interventionpercentage (Number)
Treatment (Combination Chemotherapy)90.1

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Induction Remission Rate

Proportion of participants with a remission after four courses of Induction therapy. (NCT00369317)
Timeframe: End of induction therapy (day 112)

InterventionProportion of participants (Number)
Treatment (Combination Chemotherapy)0.984615

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Overall Survival (OS) at 3 Years

(NCT00369317)
Timeframe: Time from study entry to death, assessed at 3 years.

Interventionpercentage (Number)
Treatment (Combination Chemotherapy)92.7

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Percentage of Patients Experiencing Grade 3 or 4 Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Proportion of participants with at least one grade 3 or higher adverse event during therapy. (NCT00369317)
Timeframe: From the beginning of induction therapy to the end of intensification therapy

InterventionProportion of participants (Number)
Treatment (Combination Chemotherapy)0.911765

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Prevalence of Leukemia Phenotype of DS Patients < 4 Years of Age at Diagnosis by Flow Cytometry

Proportion of participants having megakaryoblastic subtype (AMkL) phenotype among patients with phenotype data available. (NCT00369317)
Timeframe: At the start of therapy

InterventionProportion of participants (Number)
Treatment (Combination Chemotherapy)0.45122

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Prevalence of of GATA1 Mutations of DS Patients < 4 Years of Age at Diagnosis

Proportion of participants having GATA1 mutation among patients with phenotype data available. (NCT00369317)
Timeframe: At baseline and at the end of therapy (intensification) or disease relapse

InterventionProportion of participants (Number)
Treatment (Combination Chemotherapy)0.891304

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Proportions of Patients in Morphologic Remission With Positive MRD by Flow Cytometry

Proportion of participants in complete remission by morphology and with positive MRD by flow cytometry among patients having evaluable remission and MRD assessment. (NCT00369317)
Timeframe: After Induction I therapy (day 28 from start of therapy)

InterventionProportion of participants (Number)
Treatment (Combination Chemotherapy)0.0935254

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Cytarabine Drug Sensitivity by R-Strip (MicroMath) Curve Fitting Program

Mean and standard deviation of area under the concentration time curve. Specimen draws were performed only with dose 1, day 1 of induction II of AraC. First sample drawn pre-infusion, then drawn 30 mins prior to the end of the infusion, and then drawn for 6 time periods post infusion up to 8 hours post infusion (and before the 2nd dose of AraC). Results are based from these multiple time points on Day 1 of Induction II only. (NCT00369317)
Timeframe: Days 1, 2, 8, and 9 of induction II

InterventionMean micromolar x minutes (Mean)
Treatment (Combination Chemotherapy)1337.279

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Event Free Survival (EFS) Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: At 4 years

InterventionProbability of EFS at 4 years (Number)
Stage IV and Slow Incomplete Response (SIR) of Lung Metastases0.89

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Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: 4 years

InterventionProbability (Number)
Stage IV and Rapid Complete Response (RCR) of Lung Metastases0.79

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Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 4 year in the study (NCT00379340)
Timeframe: At 4 years

InterventionProbability of EFS at 4 years (Number)
Stage III/IV With LOH 1p and 16q Treated With Regimen M0.90
Stage IV With Non-lung Disease Treated With Regimen M0.73

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Event Free Survival Associated With the Burden of Pulmonary Metastatic Disease

Probability of no relapse, secondary malignancy, or death after 4 year in the study. (NCT00379340)
Timeframe: At 4 years

InterventionProbability (Number)
Lung Mets <= 1cm0.88
Lung Mets > 1cm0.82

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Frequency and Severity of Adverse Effects

Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy. (NCT00381680)
Timeframe: Up to 107 weeks

Interventionpercentage of participants (Number)
CC or CT genotypeHigh-risk CEP72 genotype (TT at rs924607)
All Patients17.344.4

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Event Free Survival (EFS)

Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse >= 36 months. (NCT00381680)
Timeframe: 3 years

,
Interventionpercentage of participants (Number)
MRD < 0.01% BL1MRD >= 0.01% BL1MRD < 0.01% BL3MRD >= 0.01% BL3
Regimen A88.560.083.861.5
Regimen B77.346.283.333.3

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Adjusted Event Free Survival

Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT). (NCT00381680)
Timeframe: 3 years

Interventionadjusted percentage of participants (Number)
Received SCTDid not receive SCT
Regimen A: Standard Vincristine Dosing82.264.2

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 3. (NCT00381680)
Timeframe: End of Block 3 (105 days) of Induction therapy

Interventionpercentage of participants (Number)
Regimen A81.4
Regimen B88.9

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1

Percentage of patients who had minimal residual disease (MRD) < 0.01% among those with isolated BM or combined BM relapse >= 36 months and had successful MRD determinations at End Block 1 (NCT00381680)
Timeframe: End of Block 1 (35 days) of Induction therapy

Interventionpercentage of participants (Number)
Regimen A50.8
Regimen B41.5

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Event Free Survival. EFS

Percentage of patients who were event free at 3 years among those on Standard VCR dosing who did not undergo Hematopoietic Stem Cell Transplant (SCT). (NCT00381680)
Timeframe: 3 years after enrollment

Interventionpercentage of participants EFS at 3 yrs3 (Number)
Regimen A: Standard Vincristine Dosing66.0

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Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen

Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event. (NCT00392990)
Timeframe: At 2 years from treatment initiation. Median follow up 34 months (range 15-45)

Interventionpercentage of patients progression free (Number)
High Risk - Treated With Alternating R-CODOX-M/R-IVAC76
Low Risk - Treatment With 3 Cycles of R-CODOX-M100

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Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen

Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason. (NCT00392990)
Timeframe: At 2 years from treatment initiation Median follow up 34 months (range 15-45)

Interventionpercentage of patients alive (Number)
High Risk - Treated With Alternating R-CODOX-M/R-IVAC81
Low Risk - Treatment With 3 Cycles of R-CODOX-M100

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Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen

"Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where:~CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.~CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow.~PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease." (NCT00392990)
Timeframe: After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks.

,
Interventionpercentage of patients (Number)
ORR after two cycles of treatmentORR at completion of treatment
High Risk - Treated With Alternating R-CODOX-M/R-IVAC100100
Low Risk - Treatment With 3 Cycles of R-CODOX-M100100

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Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate)

"Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.~In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE" (NCT00392990)
Timeframe: After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients.

,
Interventionparticipants (Number)
Anemia : Grade 3Anemia : Grade 4Neutropenia : Grade 3Neutropenia : Grade 4Thrombocytopenia : Grade 3Thrombocytopenia : Grade 4Mucositis : Grade 3Mucositis : Grade 4Infection : Grade 3Infection : Grade 4Elevated Transaminases : Grade 3Elevated Transaminases : Grade 4Fever (Neutropenic) : Grade 3Fever (Neutropenic) : Grade 4Low Phosphate : Grade 3Low Phosphate : Grade 4Sodium Abnormalities : Grade 3Sodium Abnormalities : Grade 4Hyperglycemia : Grade 3Hyperglycemia : Grade 4Hypoalbuminemia : Grade 3Hypoalbuminemia : Grade 4Hypokalemia : Grade 3Hypokalemia : Grade 4Cardiac : Grade 3Cardiac : Grade 4Diarrhea : Grade 3Diarrhea : Grade 4Elevated Creatinine : Grade 3Elevated Creatinine : Grade 4Nausea/Vomiting : Grade 3Nausea/Vomiting : Grade 4Low Blood Pressure : Grade 3Low Blood Pressure : Grade 4Rash : Grade 3Rash : Grade 4Edema : Grade 3Edema : Grade 4Low Magnesium : Grade 3Low Magnesium : Grade 4
High Risk - Treated With Alternating R-CODOX-M/R-IVAC131561137380604050401540103020201010101010
Low Risk - Treatment With 3 Cycles of R-CODOX-M3022122010203010203000200000000000000000

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Disease-free Survival (DFS) Rate at 1 Year

"For participants who achieved a complete remission (CR), this is the percentage of participants who were alive and relapse free at 1 year. The 1 year rate, with 95% confidence interval, was estimated using the Kaplan-Meier method~A CR is defined as those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood and normal complete blood count (absolute neutrophils > 1000 mL and platelets >= 100,000 mL)." (NCT00416598)
Timeframe: At 1 year

Interventionpercentage of participants (Number)
Decatibine Maintenance80

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Number of Participants Who Completed Maintenance Decitabine.

To determine feasibility of decitabine maintenance, this outcome measures the number of participants who completed all 8 planned cycles of decitabine maintenance as per protocol. (NCT00416598)
Timeframe: Up to 5 years

Interventionparticipants (Number)
Decatibine Maintenance62

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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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Maximum Tolerated of Sunitinib Combined With Cisplatin and Etoposide (Phase I)

The maximum tolerated dose is defined at the highest sunitinib dose at which less than one third of participants develop a dose limiting toxicity (DLT). A DLT is defined as: delay of beginning cycle 2 of chemotherapy by > 7 days due to neutropenia, grade 4 hematologic toxicity lasting greater than 1 week (chemotherapy alone would be expected to cause significant grade 4 hematologic toxicity) or grade 3 or 4 nonhematologic toxicity (excluding grade 3 or 4 fatigue if the patient is found to be hypothyroid and responds to fatigue < grade 3 with thyroid replacement therapy). (NCT00453154)
Timeframe: 21 days

Interventionmg/day (Number)
Cohort 125

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Overall Survival

Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method. (NCT00453154)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Combination Chemotherapy + Sunitinib Maintenance)9.0
Arm II (Combination Chemotherapy + Placebo Maintenance)6.9

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Progression-free Survival (Phase II)

Progression free survival (PFS) was defined as the time from maintenance randomization to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method. (NCT00453154)
Timeframe: Up to 3 years

Interventionmonths (Median)
Arm I (Combination Chemotherapy + Sunitinib Maintenance)3.7
Arm II (Combination Chemotherapy + Placebo Maintenance)2.1

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Number of Participants With Overall Tumor Response

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. Overall tumor response is the total number of CR and PRs. (NCT00453154)
Timeframe: Up to 3 years

,
Interventionparticipants (Number)
Complete ResponsePartial Response
Arm I (Combination Chemotherapy + Sunitinib Maintenance)34
Arm II (Combination Chemotherapy + Placebo Maintenance)05

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Participant Progression Free Survival at 2 Years

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

Interventionparticipants (Number)
Campath-1H15

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Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. (NCT00536601)
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

InterventionProportion of participants (Number)
BuCyCBVVCp
Non-Hodgkin Lymphoma22370

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Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. (NCT00536601)
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

InterventionProportion of participants (Number)
Mel120Mel200
MM/Amyloid2213

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Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. (NCT00536601)
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

InterventionProportion of participants (Number)
BuCyCBV
Hodgkin Lymphoma1443

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Response Rate (Complete Remission)

Response rates will be reported using descriptive statistics. (NCT00536601)
Timeframe: At 100 days

InterventionParticipants (Count of Participants)
Acute Leukemia5
Hodgkin Lymphoma17
Non-Hodgkin Lymphoma54
MM/Amyloid17
Solid Tumors7

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Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. (NCT00536601)
Timeframe: Patients are followed up to maximum of 12 years

InterventionProportion of participants (Number)
Acute Leukemia33
Hodgkin Lymphoma61
Non-Hodgkin Lymphoma45
MM/Amyloid39
Solid Tumors46

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Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. (NCT00536601)
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

InterventionProportion of participants (Number)
BuCy
Acute Leukemia33

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Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. (NCT00536601)
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years

InterventionProportion of participants (Number)
VCpCyTtCpTtC1500
Solid Tumors43050

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Overall Survival

Overall Survival was defined as time (in weeks) from enrollment to death. The median is based on Kaplan-Meier estimate, with 95% confidence intervals about the median overall survival. Overall survival was censored at the last time participant was known to be alive for those who were alive at time of analysis. (NCT00537511)
Timeframe: From enrollment through study termination (approximately 35 months)

Interventionweeks (Median)
Pomalidomide (Overall)49.6

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase

Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. 'Related' = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. (NCT00537511)
Timeframe: Cycle 7 to discontinuation (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide during Maintenance Phase was 5.0 (1.1, 36.0).

Interventionparticipants (Number)
≥1 TEAE≥1 TEAE related to pomalidomide (POM)≥1 TEAE related to cisplatin and/or etoposide (C/E≥1 Grade 3 or higher (GR3+) TEAE≥1 GR 3+ TEAE related to POM≥1 GR 3+ TEAE related to C/E≥1 TEAE → dose reduction/interruption of POM
Pomalidomide (Overall)9876222

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Maximum Tolerated Dose (MTD)

The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.) (NCT00537511)
Timeframe: Cycle 1 (21 days)

Interventionmg (Number)
Pomalidomide (Overall)4

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Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase

Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participant's health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death. (NCT00537511)
Timeframe: Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).

,,,,
Interventionparticipants (Number)
≥1 TEAE≥1 TEAE related to pomalidomide (POM)≥1 TEAE related to cisplatin and/or etoposide(C/E)≥1 Grade 3 or higher (GR3+) TEAE≥1 GR 3+ TEAE related to POM≥1 GR 3+ TEAE related to C/E≥1 Serious TEAE≥1 Serious TEAE related to POM≥1 Serious TEAE related to C/E≥1 TEAE leading to (→) withdrawal of POM≥1 TEAE → withdrawal of C/E≥1 TEAE → dose reduction/interruption of POM≥1 TEAE → dose reduction/interruption of C/E
Pomalidomide (Overall, MTD Phase)2222222214201079661513
Pomalidomide 1 mg6666363222253
Pomalidomide 3 mg4444231110123
Pomalidomide 4 mg6666463132143
Pomalidomide 5 mg6666553332244

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Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase

For the purposes of determining the MTD (see Primary Outcome Measure), a DLT was defined as any 1 or more of the following: inability to deliver all 3 doses of cisplatin and etoposide due to toxicity; inability to deliver 14 consecutive days of daily pomalidomide dosing because the participant did not tolerate the medication due to any of the following: ≥ grade 3 non-hematological toxicity (excluding alopecia) occurring before Day 14 of pomalidomide dosing; febrile neutropenia (absolute neutrophil count [ANC] <1,000/µL and fever >101ºF, core temperature); grade 4 neutropenia of ≥7 days duration with onset on or before Day 14 of pomalidomide dosing; platelet count <25,000/µL occurring before Day 14 of pomalidomide dosing. National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 4.0, grades: 1=mild, 2=moderate, 3=severe, 4=life threatening, 5=death. (NCT00537511)
Timeframe: Cycles 1 - 6 (21-day cycles)

Interventionparticipants (Number)
Pomalidomide 1 mg1
Pomalidomide 3 mg0
Pomalidomide 4 mg0
Pomalidomide 5 mg2

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Duration of Response

Duration of Response was calculated from first Partial Response (PR) or Complete Response (CR) to disease progression. Duration of response was censored at the last date that the participant was known to be progression-free for: 1) participants who had not progressed at the time of analysis; 2) participants who had been removed from the treatment phase prior to documentation of progression. (NCT00537511)
Timeframe: From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)

Interventionweeks (Mean)
Pomalidomide (Overall)13.2

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Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)

Investigator's best assessment of response based on RECIST criteria during the MTD phase. For target lesions: Complete Response (CR)=Disappearance of all target lesions; Partial Response (PR)=≥30% decrease in sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; Progressed Disease (PD)=≥20% increase in sum of LD of target lesions taking as reference the smallest sum LD recorded since treatment started or the appearance of ≥1 new lesions; Stable Disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since treatment started. For non-target lesions: CR= Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/SD=Persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits; PD=Appearance of ≥1 new lesions; unequivocal progression of existing non-target lesions. (NCT00537511)
Timeframe: Cycles 1 -6 (21-day cycles)

,,,,
Interventionparticipants (Number)
Complete ResponsePartial ResponseNo Change/Stable DiseaseProgressive DiseaseNot AssessedMissing
Pomalidomide (Overall, MTD Phase)0110416
Pomalidomide 1 mg030102
Pomalidomide 3 mg030100
Pomalidomide 4 mg020112
Pomalidomide 5 mg030102

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Maximum Tolerated Dose (MTD) of Intensity-modulated Radiation Therapy (Phase I)

The highest dose tested in which fewer than 33% of patients experienced DLT attributable to the study treatment when at least six patients were treated at the dose and are evaluable for toxicity. The MDT is one dose level below the DLT level. At least six patients will be treated at the MTD. (NCT00540995)
Timeframe: from initial treatment date to Day 30 post-transplant

InterventioncGy (Number)
Arm I: 1200cGy1200

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Probability of Event-free Survival

"To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111).~EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission." (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 350092.4
TOTXVI PEG 250091.1
TOTXVI Not Randomized86.3
All Eligible Patients in TOTXV87.1

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Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.

"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).~The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (<0.01%). Past experience indicate that few patients will fall into these unknown categories." (NCT00549848)
Timeframe: 3.5 years after the last enrollment up to 12.5 years

InterventionPercentage of participants (Number)
PEG 3500 Units/m^291.6
PEG 2500 Units/m^290.7

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Probability of CNS Relapse

To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 35000.8
TOTXVI PEG 25001.8
TOTXVI Not Randomized2.7
All Eligible Patients in TOTXV5.7

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Probability of Overall Survival

To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

InterventionPercentage of participants (Number)
TOTXVI PEG 350097.5
TOTXVI PEG 250095.6
TOTVI Not Randomized90.8
All Eligible Patients in TOTXV93.5

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Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%

To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV

InterventionParticipants (Count of Participants)
TOTXVI PEG 350022
TOTXVI PEG 250026
TOTXVI Not Randomized31
All Eligible Patients in TOTXV55

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Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%

To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XV

InterventionParticipants (Count of Participants)
TOTXVI PEG 35007
TOTXVI PEG 250012
TOTXVI Not Randomized20
All Eligible Patients in TOTXV44

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Percentage of Participants With Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Grade 3 and higher toxicities will be descriptively summarized. (NCT00554788)
Timeframe: Up to 30 days after completion of study treatment

,,
Interventionpercentage of participants (Number)
Abdominal painAcute kidney injuryAlanine aminotransferase increasedAnemiaAnorexiaApneaAspartate aminotransferase increasedCatheter related infectionDehydrationDepressed level of consciousnessDiarrheaEncephalopathyEnterocolitisEnterocolitis infectiousEsophagitisFebrile neutropeniaFeverGGT increasedGastric hemorrhageHearing impairedHypermagnesemiaHypertensionHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaInfections and infestations - Other, specifyLower gastrointestinal hemorrhageLung infectionLymphocyte count decreasedMucositis oralNauseaNervous system disorders - Other, specifyNeutrophil count decreasedOral painPainPeripheral motor neuropathyPharyngeal mucositisPlatelet count decreasedPneumonitisRectal painSeizureSepsisSinus tachycardiaSinusitisSkin infectionUpper respiratory infectionVomitingWhite blood cell decreased
Stage 2/3 Patients000011.10011.1005.6005.6055.611.10011.15.6005.6027.85.611.122.20027.8016.705.616.705.6005.605.65.6000011.1011.111.15.6
Stage 4a Patients5.65.616.7033.3011.1011.1016.705.611.15.655.605.65.65.605.605.6016.75.60011.12.633.35.60027.811.1005.65.605.6005.6011.15.605.65.622.20
Stage 4b Patients005.35.315.85.35.3010.55.305.305.3036.85.3005.3005.310.55.321.110.515.810.50021.1005.35.35.310.55.300005.3005.30005.305.35.3

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Event-free Survival (EFS)

The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause. (NCT00554788)
Timeframe: At 1 year

InterventionProbability (Number)
Stage 2/3 Patients88
Stage 4a Patients83
Stage 4b Patients28

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Response Rate to the Induction Phase of the Regimen

This study used a modified version of the international criteria for neuroblastoma response. The response rate to the induction phase of the regimen and a corresponding 95% confidence interval will be calculated for all strata combined. (NCT00554788)
Timeframe: 12 weeks after participant received the first dose

Interventionpercentage of participants (Number)
All Eligible Patients68

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Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm C (Safety/Efficacy Dose Level 2)35.82

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Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy

Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction

InterventionActivity percentage (Mean)
Arm C (Safety/Efficacy Dose Level 2)69.00

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Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm

Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)

Interventionpercent probability (Number)
Arm A (MRD Negative)86.05
Arm A (MRD Positive)87.5
Arm B (MRD Negative)47.37
Arm B (MRD Positive)22.73
Arm C (MRD Negative)51.85
Arm C (MRD Positive)27.03

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Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionqPCR fold expression ratio (Mean)
Arm A (Standard Risk MLL-G)1.25
Arm B (IR/HR MLL-R Chemotherapy)7.85
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)5.83

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Percent Probability for Event-free Survival (EFS) for Patients on Arm A

EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years

Interventionpercentage probability (Number)
Arm A (Standard Risk MLL-G)86.67

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Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2

Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.

Interventionpercent probability (Number)
Arm B (IR/HR MLL-R Chemotherapy)38.89
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)35.82

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Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction

InterventionProportion of cells that are viable (Median)
Arm A (Standard Risk MLL-G)0.75
Arm B (IR/HR MLL-R Chemotherapy)0.48
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.47

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Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionProportion of cells that are viable (Mean)
Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib)0.69

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Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts

Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)

InterventionqPCR fold expression ratio (Mean)
Arm C (Safety/Efficacy Dose Level 2)5.73

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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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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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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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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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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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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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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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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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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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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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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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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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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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Progression-free Survival (PFS), and Overall Survival (OS)

To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause. (NCT00571493)
Timeframe: one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT

Interventionpercentage of participants (Number)
Progression Free Survival 1 year after transplantOverall Survival 1 year after transplantProgression Free Survival 5 years after transplantOverall Survival 5 years after transplant
Phase II: Progression Free Survival and Overall Survival83913267

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Preliminary Estimate of Overall Response Rate (ORR)

To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients. (NCT00571493)
Timeframe: 100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT

Interventionparticipants (Number)
Overall Response Rate (100 days after transplant)Overall Response Rate (1 year after transplant)
Phase II: Overall Response Rate3833

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Maximum Tolerated Dose (MTD) of Bortezomib

The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort. (NCT00571493)
Timeframe: 14 months

Interventionmg/m² (Number)
Phase I1.5
Phase II1.0

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Maximum Tolerated Dose of Intensity-modulated Radiotherapy (Phase I)

Toxicities will be recorded using two distinct grading systems: the modified Bearman scale and the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 3.0 scale. (NCT00576979)
Timeframe: 30 days post transplant

InterventioncGy (Number)
All Levels: 1200 cGy to 2000cGy2000

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Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy

the measure is the number of patients who have surgery after two cycles of induction (NCT00578864)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Phase II Window With Protracted Etoposide4
Phase II Window With Bolus Etoposide2

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Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.

(NCT00578864)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Phase II Window With Protracted Etoposide3
Phase II Window With Bolus Etoposide2

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Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.

Partial response or better (NCT00578864)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Phase II Window With Protracted Etoposide1
Phase II Window With Bolus Etoposide2

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Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.

If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC > 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia (NCT00578864)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Phase II Window With Protracted Etoposide0
Phase II Window With Bolus Etoposide0

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Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.

The first of the two events (relapse or death) was chosen to represent disease free survival (NCT00578864)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Phase II Window With Protracted Etoposide2
Phase II Window With Bolus Etoposide1

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Maximum Tolerated Dose of Vorinostat

(NCT00601718)
Timeframe: 28 days post last dose of study drug

Interventionmg twice daily X 5 days (Number)
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy500

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Safety and Toxicity According to CTCAE v3.0

Common dose limiting toxicities. (NCT00601718)
Timeframe: 3-5 weeks post end of treatment

InterventionParticipants (Count of Participants)
InfectionHypokalemiaTransaminitisGrade 3 related gastrointestinal toxicity
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy2229

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Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment

(NCT00601718)
Timeframe: 1-3 weeks post end of treatment

InterventionParticipants (Count of Participants)
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy20

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Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy

(NCT00601718)
Timeframe: 3-5 weeks post end of treatment

InterventionParticipants (Count of Participants)
Treatment (Enzyme Inhibitor, Monoclonal Antibody, Chemotherapy19

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Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan

Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

Interventionparticipants (Number)
Intermediate-Risk Group0
High-Risk Group8

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Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan

Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

Interventionparticipants (Number)
Intermediate-Risk Group1
High-Risk Group20

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Percent of Patients With Sustained Objective Responses Rate After Consolidation

For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response. (NCT00602667)
Timeframe: 8 weeks after completion of consolidation therapy (up to 8 months after on-study date)

Interventionpercentage of participants (Number)
High-Risk Group13.2

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Percent of PET Scans With Loss of Signal Intensity

Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay. (NCT00602667)
Timeframe: Up to 3 times during RT consolidation

Interventionmean activation value (MAV) (Mean)
Intermediate Risk Group60

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Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients

Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after

InterventionPercent Probability (Number)
Low-Risk Group73.9
Intermediate-Risk Group46.9
High-Risk Group30.8

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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients

Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis. (NCT00602667)
Timeframe: From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

InterventionPercent Probability (Number)
Low-Risk Group73.9
Intermediate-Risk Group46.9
High-Risk Group30.8

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Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup

Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile. (NCT00602667)
Timeframe: From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment

InterventionPercent Probability (Number)
Low-risk SHH Patients73.9
Intermediate-risk SHH Patients50.0
High-risk SHH Patients54.5
Intermediate-risk Group 3 Patients30.8
High-risk Group 3 Patients9.1
Intermediate-risk Group 4 Patients62.5
High-risk Group 4 Patients50.0

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Percentage of Patients With Objective Responses Rate to Induction Chemotherapy

For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response [ PR]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks. (NCT00602667)
Timeframe: From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)

InterventionPercentage of patients (Number)
Intermediate-Risk Group58.3
High-Risk Group21.1

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Rate of Distant Disease Progression

Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient

Interventionpercentage of participants (Number)
Intermediate-risk Patients Who Received Focal Radiation25.6

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Rate of Local Disease Progression

Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval. (NCT00602667)
Timeframe: 1 year after completion of radiation therapy for last patient

InterventionPercentage of participants (Number)
Intermediate-risk Patients Who Received Focal Radiation13.2

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Topotecan Apparent Oral Clearance in Maintenance Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5 and 6 hours post-dose

InterventionL/h (Median)
Low-Risk Group41.4
Intermediate-Risk Group41.0
High-Risk Group44.6

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Pharmacogenetic Variation on Central Nervous System Transmitters

Frequencies of genetic polymorphisms were reported. (NCT00602667)
Timeframe: At study enrollment (Day 0)

InterventionParticipants (Count of Participants)
Genetic Polymorphisms for monoamine oxidase A (MAOA) rs632372067969Genetic Polymorphisms for catecholamine-O-methyltransferase (COMT) rs468072067969Genetic Polymorphisms for dopamine receptor D (DRD3) rs628072067969
AGCCTCTTGGAATG
Patients With Neurotransmitter Studies2
Patients With Neurotransmitter Studies13
Patients With Neurotransmitter Studies7
Patients With Neurotransmitter Studies5
Patients With Neurotransmitter Studies0
Patients With Neurotransmitter Studies6
Patients With Neurotransmitter Studies4

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Numbers of Patients With Gene Alterations

Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
PTCH1 alterationSUFU alterationKMT2D alterationSMO alterationBCOR alterationPTEN alterationBRCA2 alterationGLI2 alterationSMARCA4 alterationTP53 alterationMYCN alteration
High-Risk Group31310000001
Intermediate-Risk Group41100000101
Low-Risk Group76521100200

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Number of Successful Collections for Frozen and Fixed Tumor Samples

Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
Number with frozen tumor tissueNumber with fixed tumor tissue
High-Risk Group3271
Intermediate-Risk Group73153
Low-Risk Group2754

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Number of Participants With Chromosomal Abnormalities

Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,
InterventionParticipants (Count of Participants)
chr2p gain/amplificationchr2p loss/deletionchr2q gain/amplificationchr2q loss/deletionchr6p gain/amplificationchr6p loss/deletionchr6q gain/amplificationchr6q loss/deletionchr8p gain/amplificationchr8p loss/deletionchr8q gain/amplificationchr8q loss/deletionchr9p gain/amplificationchr9p loss/deletionchr9q gain/amplificationchr9q loss/deletionchr10p gain/amplificationchr10p loss/deletionchr10q gain/amplificationchr10q loss/deletionchr20p gain/amplificationchr20p loss/deletionchr20q gain/amplificationchr20q loss/deletion
High-Risk Group606032320807331507090505
Intermediate-Risk Group121230302635601505070403
Low-Risk Group505010101010442600030201

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Number and Type of Genetic Polymorphisms

Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280. (NCT00602667)
Timeframe: At study enrollment (Day 0)

InterventionParticipants (Count of Participants)
rs6323rs4680rs6280
Number of Patients With Neurotransmitter Studies171717

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Concentration of Cerebrospinal Fluid Neurotransmitters

Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range. (NCT00602667)
Timeframe: Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date

Interventionng/ml (Median)
Dopamine concentration at baselineDopamine concentration at completion of treatmentDopamine concentration at 12 months off treatmentDopamine concentration at 24 months off treatmentDopamine concentration at 36 months off treatment3,4-dihydroxyphenylacetic acid concentration at baseline3,4-dihydroxyphenylacetic acid concentration at completion of treatment3,4-dihydroxyphenylacetic acid concentration at 12 months off treatment3,4-dihydroxyphenylacetic acid concentration at 24 months off treatment3,4-dihydroxyphenylacetic acid concentration at 36 months off treatmentHydroxytryptamine concentration at baselineHydroxytryptamine concentration at completion of treatmentHydroxytryptamine concentration at 12 months off treatmentHydroxytryptamine concentration at 24 months off treatmentHydroxytryptamine concentration at 36 months off treatmentHydroxyindoleacetic acid concentration at baselineHydroxyindoleacetic acid concentration at completion of treatmentHydroxyindoleacetic acid concentration at 12 months off treatmentHydroxyindoleacetic acid concentration at 24 months off treatmentHydroxyindoleacetic acid concentration at 36 months off treatmentHomovanillic acid concentration at baselineHomovanillic acid concentration at completion of treatmentHomovanillic acid concentration at 12 months off treatmentHomovanillic acid concentration at 24 months off treatmentHomovanillic acid concentration at 36 months off treatment
Patients With Neurotransmitter Studies3.163.706.434.464.052.561.621.041.521.002.382.012.002.441.6252.0352.7235.7233.9831.5682.44114.1368.2888.2779.78

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Topotecan Clearance in Consolidation Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, and 3 hours from end of infusion

InterventionL/h/m^2 (Median)
Intermediate-Risk Group30.3
High-Risk Group26.40

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CEPM AUC0-24h in Induction Chemotherapy

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group140.2
Intermediate-Risk Group137.8
High-Risk Group135.3

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CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group1.59
Intermediate-Risk Group1.65
High-Risk Group1.41

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Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1

Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose

InterventionL/h/m^2 (Median)
Low-Risk Group2.95
Intermediate-Risk Group2.83
High-Risk Group2.74

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Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group1968
Intermediate-Risk Group1504
High-Risk Group868

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Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group1966
Intermediate-Risk Group799
High-Risk Group899

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Methotrexate Volume of Central Compartment in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group13.77
Intermediate-Risk Group13.73
High-Risk Group13.62

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Cyclophosphamide AUC0-24h in Induction Chemotherapy

Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group2070
Intermediate-Risk Group2150
High-Risk Group2105

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Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1

Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group39.9
Intermediate-Risk Group38.7
High-Risk Group42.2

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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.39
Intermediate-Risk Group2.08
High-Risk Group2.43

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Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2

Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.48
Intermediate-Risk Group2.55
High-Risk Group2.37

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Cyclophosphamide Clearance in Induction Chemotherapy

Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

InterventionL/h/m^2 (Median)
Low-Risk Group2.40
Intermediate-Risk Group2.23
High-Risk Group2.25

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Erlotinib Apparent Oral Clearance

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

InterventionL/h/m^2 (Median)
Low-Risk Group6.53
Intermediate-Risk Group7.79
High-Risk Group8.40

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Erlotinib Apparent Volume of Central Compartment

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

InterventionL/m^2 (Median)
Low-Risk Group72.9
Intermediate-Risk Group61.7
High-Risk Group104.8

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Erlotinib AUC0-24h

Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group31.0
Intermediate-Risk Group23.5
High-Risk Group22.0

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Event-free Survival (EFS) Compared to Historical Controls

EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years

InterventionPercent probability (Number)
SJYC07 Low-risk Medulloblastoma Patients73.9
SJYC07 Intermediate-risk Medulloblastoma Patients46.9
SJYC07 High-risk Medulloblastoma Patients30.8

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Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy. (NCT00602667)
Timeframe: At completion of consolidation therapy (up to 6 months after on-study date)

InterventionPercentage of courses delayed (Number)
High-Risk Group2.6

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Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received

These data are based on patient diaries. For children <3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question. (NCT00602667)
Timeframe: From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)

InterventionPercentage of scheduled doses received (Mean)
Low-Risk Group96
Intermediate-Risk Group91
High-Risk Group98

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Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity

For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy. (NCT00602667)
Timeframe: From on-study date up to 4 months after on-study date

InterventionPercentage of courses delayed (Number)
High-Risk Group3.8

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Methotrexate AUC0-66h in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1797
Intermediate-Risk Group1813
High-Risk Group1821

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Methotrexate AUC0-66h in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1900
Intermediate-Risk Group1902
High-Risk Group1879

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CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group128.9
Intermediate-Risk Group62.2
High-Risk Group51.8

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Methotrexate Clearance in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)

InterventionL/h/m^2 (Median)
Low-Risk Group5.69
Intermediate-Risk Group6.06
High-Risk Group5.65

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Methotrexate AUC0-66h in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1872
Intermediate-Risk Group1879
High-Risk Group1831

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Methotrexate AUC0-66h in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

Interventionµmol·h/L (Median)
Low-Risk Group1804
Intermediate-Risk Group1841
High-Risk Group1886

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Numbers of Patients With Molecular Abnormalities by Tumor Type

Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values. (NCT00602667)
Timeframe: Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment

,,,,,,
InterventionParticipants (Count of Participants)
PTCH1 alterationSUFU alterationKMT2D alterationSMO alterationBCOR alterationPTEN alterationBRCA2 alterationGLI2 alterationSMARCA4 alterationTP53 alterationMYCN amplificationchr2p gain/amplificationchr2p loss/deletionchr2q gain/amplificationchr2q loss/deletionchr6p gain/amplificationchr6p loss/deletionchr6q gain/amplificationchr6q loss/deletionchr8p gain/amplificationchr8p loss/deletionchr8q gain/amplificationchr8q loss/deletionchr9p gain/amplificationchr9p loss/deletionchr9q gain/amplificationchr9q loss/deletionchr10p gain/amplificationchr10p loss/deletionchr10q gain/amplificationchr10q loss/deletionchr20p gain/amplificationchr20p loss/deletionchr20q gain/amplificationchr20q loss/deletion
High-risk Group 3 Patients00000000001101032320706030307080404
High-risk Group 4 Patients00000000000000000000101000000000000
High-risk SHH Patients31310000000404000000000301200010101
Intermediate-risk Group 3 Patients00000000100010120201221100005050303
Intermediate-risk Group 4 Patients00000000000010110100404101000000000
Intermediate-risk SHH Patients41100000001000000000000400500020100
Low-risk SHH Patients76521100200505010101010442600030201

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Methotrexate Clearance in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.47
Intermediate-Risk Group5.70
High-Risk Group5.70

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Topotecan AUC0-24h in Consolidation Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion

Interventionµg·h/L (Median)
Intermediate-Risk Group117
High-Risk Group116

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Topotecan AUC0-24h in Maintenance Chemotherapy

Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose

Interventionµg·h/L (Median)
Low-Risk Group10.90
Intermediate-Risk Group11.60
High-Risk Group10.33

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Methotrexate Clearance in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.68
Intermediate-Risk Group5.78
High-Risk Group5.81

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Methotrexate Clearance in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/h/m^2 (Median)
Low-Risk Group5.75
Intermediate-Risk Group5.89
High-Risk Group5.79

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.49
Intermediate-Risk Group0.57
High-Risk Group0.61

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.75
Intermediate-Risk Group0.72
High-Risk Group0.69

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.65
Intermediate-Risk Group0.70
High-Risk Group0.58

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Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis. (NCT00602667)
Timeframe: 42 hours from start of MTX

Interventionµmol/L (Median)
Low-Risk Group0.64
Intermediate-Risk Group0.64
High-Risk Group0.55

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Methotrexate Volume of Central Compartment in Induction Cycle 1

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group11.63
Intermediate-Risk Group13.70
High-Risk Group13.25

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Methotrexate Volume of Central Compartment in Induction Cycle 3

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group12.70
Intermediate-Risk Group13.55
High-Risk Group13.87

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Methotrexate Volume of Central Compartment in Induction Cycle 4

Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion and 6, 23, 42, 66 hours from start of MTX

InterventionL/m^2 (Median)
Low-Risk Group12.64
Intermediate-Risk Group13.31
High-Risk Group13.68

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OSI-420 AUC0-24h

Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 1, 2, 4, 8, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group2.17
Intermediate-Risk Group1.81
High-Risk Group1.62

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Overall Survival (OS) Compared to Historical Controls

OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals. (NCT00602667)
Timeframe: 1 year after treatment initiation of last patient

InterventionPercent probability (Number)
SJYC07 Low-risk Medulloblastoma Patients100
SJYC07 Intermediate-risk Medulloblastoma Patients84.4
SJYC07 High-risk Medulloblastoma Patients61.5

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4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1

4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose

Interventionµmol·h/L (Median)
Low-Risk Group1.98
Intermediate-Risk Group1.96
High-Risk Group1.82

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4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy

4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group116.4
Intermediate-Risk Group111.3
High-Risk Group109.1

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4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2

4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group95.9
Intermediate-Risk Group49.5
High-Risk Group43.5

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4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1

4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group96.8
Intermediate-Risk Group48.7
High-Risk Group39.8

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CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2

Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis. (NCT00602667)
Timeframe: Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion

Interventionµmol·h/L (Median)
Low-Risk Group132.7
Intermediate-Risk Group46.8
High-Risk Group44.0

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Complete Response

Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/mcL and a platelet count of 100,000 mcL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. A CR must be confirmed 4 to 6 weeks after the initial documentation. If possible, at least one bone marrow biopsy should be performed to confirm the CR. (NCT00602771)
Timeframe: 6 months

Interventionparticipants (Number)
Arm I0
Arm II (Closed to Accrual as of November 2008)0

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Safety of Study Treatment Regimen

Number of participants experiencing a non-hematologic toxicity ≥ grade 3 that was possibly, probably, or definitely related to study treatment. (NCT00612430)
Timeframe: 2 years

Interventionparticipants (Number)
Grade III9
Grade IV13

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6 Month Progression-Free Survival (PFS)

Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression. Progression was defined as greater than or equal to a 25% increase in the product of the largest perpendicular diameters of any enhancing lesion or any new enhancing tumor on MRI scans. (NCT00612430)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Grade III41
Grade IV44

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Median Overall Survival (OS)

Time in weeks from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve. (NCT00612430)
Timeframe: median of 91.4 weeks

Interventionweeks (Median)
Grade III63.1
Grade IV46.4

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Median Progression-Free Survival

Time in weeks from the start of study treatment to the date of first progression, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. (NCT00612430)
Timeframe: Patients were followed for a median of 91.4 weeks

Interventionweeks (Median)
Grade III24
Grade IV18

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Objective Response Rate

The percentage of participants with complete or partial response as determined by the following criteria: complete response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination; partial response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination. A confirmation of response was not required. (NCT00612430)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Grade III24
Grade IV23

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Incidence of Death

Incidence of death from complications of therapy while the patient is on protocol therapy or within one month of terminating protocol therapy (NCT00618813)
Timeframe: Length of protocol therapy (up to 37 weeks) plus 30 days

Interventionparticipants (Number)
Treatment (Combination Chemotherapy)0

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Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Enrollment to Week 12

The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Enrollment to week 12

Interventionparticipants (Number)
Treatment (Combination Chemotherapy)12

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Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 13 to Week 22

The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 13 to week 22

Interventionparticipants (Number)
Treatment (Combination Chemotherapy)9

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Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 23 to Week 28

The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 23 to week 28

Interventionparticipants (Number)
Treatment (Combination Chemotherapy)9

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Incidence Rate (Number of Participants) of Dose-limiting Toxicity (DLT) - Week 29 to Week 37

The incidence rate of DLT while on protocol therapy where DLT is defined as (1) Grade 3 or greater nonhematological adverse event that is possibly, probably, or likely related to therapy with the specific exception of Grade 3 or greater nausea or vomiting controlled by standard supportive care measures, Grade 3 infection and Grade 3 alopecia; or (2) Grade 4 or higher hematological AE that delays the administration of therapy at least 2 weeks. (NCT00618813)
Timeframe: Week 29 to week 37

Interventionparticipants (Number)
Treatment (Combination Chemotherapy)14

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The Rate of Complete Remission (CR+CRi)

CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L). (NCT00634244)
Timeframe: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.

Interventionproportion of participants (Number)
Arm A (Carboplatin+Topotecan Hydrochloride)0.143
Arm B (Alvocidib+Cytarabine+Mitoxantrone)0.278
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)0.15

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The Rate of Treatment Failure

"The definition of treatment failure will include:~≥ 5% leukemic blasts at the time of pre-consolidation marrow~Death during/following induction chemotherapy (pre-consolidation)~Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy~CNS or extramedullary disease at the time of pre-consolidation~Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy" (NCT00634244)
Timeframe: Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.

Interventionproportion of participants (Number)
Arm A (Carboplatin+Topotecan Hydrochloride)0.86
Arm B (Alvocidib+Cytarabine+Mitoxantrone)0.72
Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)0.84

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Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy

Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy. (NCT00653068)
Timeframe: During protocol therapy up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
AcidosisAcute kidney injuryApneaAdult respiratory distress syndromeAspirationAtelectasisCatheter related infectionCentral nervous system necrosisDehydrationDiarrheaDissmeminated intravascular coagulation (DIC)EnterocolitisFebrile neutropeniaHearing impairmentHematuriaHydrocephalusHypernatremiaHypoalbuminemiaHypocalcemiaHypoglycemiaHypokalemiaHyponatremiaHypophosphatemiaHypotensionHypoxiaIncreased Alanine aminotransferaseIncreased Aspartate aminotransferaseIncreased LipaseIntracranial hemorrhagentraoperative venous injuryLaryngospasmLeft ventricular systolic dysfunctionLung infectionMulti-organ failureMucositis oralPoisoning and procedural complicationsOther gastrointestinal disordersOther infectionPneumonitisProductive coughPulmonary edemaRecurrent laryngeal nerve palsyRenal calculiRespiratory failureSeizureSepsisSinus tachycardiaStridorUpper respiratory infectionVascular access complicationVoice alterationVomitingWeight loss
All Patients11213121111161111132922465412111313117211113262211111

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Toxic Death

The number of patients who experience death that is considered to be primarily attributable to complications of treatment. (NCT00653068)
Timeframe: During and after completion of study treatment up to 1 year after enrollment.

InterventionParticipants (Count of Participants)
Stratum I3
Stratum III1

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Overall Survival (OS)

Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated Probability (Number)
Stratum I0.3888
Stratum III0.5486

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Event-free Survival

Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT00653068)
Timeframe: Up to 4 years after study enrollment

InterventionEstimated probability (Number)
Stratum I0.3401
Stratum III0.4500

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Dose Limiting Toxicity

Number of participants with dose limiting toxicity. (NCT00666588)
Timeframe: During Course 1

Interventionparticipants (Number)
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp1
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp0
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp0

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Overall Response (Complete Remission [CR] and CR With Partial Recovery [CRp]) During Course 1

Overall response (complete remission [CR] and CR with partial recovery [CRp]) during course 1. (NCT00666588)
Timeframe: After course 1

Interventionparticipants (Number)
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure4
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp2
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp2
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp9

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Feasibility of Stem Cell Quantitation: Percentage of Leukemia Initiation Cells (LIC) Depletion

Descriptive statistics to assess mean +/- standard deviation for the percentage leukemia initiation cells (LIC) depletion. (NCT00666588)
Timeframe: At baseline and after completion of course 1

,,
Interventionpercentage of LIC depletion (Mean)
Prior to TreatmentPost Treatment
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp1.63850.0435
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp0.20.43
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0.0136670.021

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NF-kB Activity by Enzyme-linked Immunosorbent Assay (ELISA)

NF-kB activity will be measured as a continuous variable (ng NF-kB/Mg protein). Differences in NF-κB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range. We may perform exploratory analyses to determine if single time point measurements, or the difference between time points, correlate with treatment response. (NCT00666588)
Timeframe: At baseline, prior to and up to 24 hours after bortezomib treatment

,,,
Interventionng/Mg protein (Mean)
Baseline24 Hrs after treatment
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp655.4345.46
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp408.144497.31
Bortezomib 1.3 mg/m2-assess Feasibility High Anthracycline Exp974.66855.96
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure718.218774.1925

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Proteasome Inhibition Activity

Mean and standard deviation of β1 and β5- Results are ratios (proteasome subunit/β-actin based on loading of 15 µg total protein, normalized to CEM). (NCT00666588)
Timeframe: At baseline

,,
Interventionratio (Mean)
Baseline β1Baseline β5
Bortezomib 1.0mg/m2-assess Feasibility High Anthracycline Exp0.78940.2576
Bortezomib 1.3 mg/m2-assess Efficacy High Anthracycline Exp0.28951430.3721286
Bortezomib 1.3mg/m2-assess Efficacy-low Anthracycline Exposure0.081150.121575

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Time to Neutrophil Recovery

Neutrophil recovery was defined as the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL. (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) till the first of 3 consecutive days of an absolute neutrophil count ≥ 500/µL.)

InterventionDays (Median)
Treatment (RIT, ZBEAM, ASCT)10

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Time to Platelet Recovery

Platelet recovery was defined as the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions. (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) till the first of 7 consecutive days with a platelet count ≥ 20,000/µL with no transfusions

InterventionDays (Median)
Treatment (RIT, ZBEAM, ASCT)12

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2-Year Cumulative Incidence of Progression

The cumulative incidence was estimated after taking into account the competing risk of early death. (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to date of first observation of progressive disease or relapsed disease, assessed up to 5 years

InterventionPercentage of Participants (%) (Number)
Treatment (RIT, ZBEAM, ASCT)28

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2-Year Overall Survival

Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.] (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to death due to any cause, assessed up to 5 years

InterventionPercentage of Participants (%) (Number)
Treatment (RIT, ZBEAM, ASCT)89

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2-Year Progression-Free Survival

Progression-free survival (PFS) was defined as time from peripheral stem cell infusion to recurrence, progression or death. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula [Breslow NE, Day NE. Statistical methods in cancer research: volume II, the design and analysis of cohort studies. IARC Sci Publ 1987;82:1-406.] (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to first observation of progressive disease or death due to any cause, whichever comes first, assessed up to 5 years

InterventionPercentage of Participants (%) (Number)
Treatment (RIT, ZBEAM, ASCT)71

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Number of Patients With Active Disease at ASCT Achieving CR/PR by Day 100 After ASCT

Responses are assessed using the Revised Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al. 2007). Complete Response (CR) defined as disappearance of all evidence of disease. Partial Response (PR) defined as regression of measurable disease and no new sites. (NCT00695409)
Timeframe: Up to Day 100 post-ASCT

InterventionParticipants (Count of Participants)
Patients With Active Disease at ASCT53

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Number of Patients With RIT/ZBEAM Developing Therapy Induced MDS and AML

Patient receiving the full treatment of RIT/ZBEAM developed therapy induced MDS or AML. (NCT00695409)
Timeframe: From peripheral stem cell infusion (Day0 ASCT) to onset of therapy induced MDS/AML, assessed up to 5 years

InterventionParticipants (Count of Participants)
Treatment (RIT, ZBEAM, ASCT)0

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2-year PFS From the Start of Induction Therapy Conditional

2-year PFS from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation. (NCT00712582)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Consolidation A86.6
Consolidation B90.6
Consolidation C0.4

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Overall Survival at 1 Year

Overall survival from the start of induction therapy conditional on attaining either a negative FDG-PET or a negative biopsy at the interim evaluation. (NCT00712582)
Timeframe: 1 year

InterventionPercent of patients (Number)
Consolidation A98.3
Consolidation B96.9
Consolidation C50.0

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Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events

Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)

InterventionPts with DLTs (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)1

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Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation

A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)10.5
Standard-risk0
High-risk66.7

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Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)

An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years

Interventionpercentage of patients (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy

Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years

InterventionPercent probability (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)79.8
Standard-risk83.2
High-risk66.7

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Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy

Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)

InterventionPercentage of participants (Number)
Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy)40.7
Standard-risk29.2
High-risk100.0

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Maximum Administered Dose of Dasatinib (Phase I)

This field captured the maximum dose of dasatinib administered. (NCT00788125)
Timeframe: 28 days after start of course 1

Interventionmg/m2 dose BID (Number)
Period 1: 35 mg/m^2/Dose BID PO Dasatinib x 17 Days35

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Continuous Complete Remission (CCR) Rate

Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months

Interventionpercentage of participants (Number)
Treatment57

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Overall Survival (OS)

OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years

InterventionProbability of surviving 12 months (Number)
Treatment0.88

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Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation

Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months

InterventionProbability of 12-month RFS (Number)
Treatment0.83

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Event Free Survival

Percentage of patients who were event free at 4 months (NCT00873093)
Timeframe: 4 months after enrollment

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs68.5
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs37.8

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 1. (NCT00873093)
Timeframe: End of Block 1 (Day 36 of Block 1) of re-induction therapy

Interventionpercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs35.4
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs25

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 2. (NCT00873093)
Timeframe: End of Block 2 (Day 36 of Block 2) of re-induction therapy

Interventionpercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs66.7
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs42.1

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Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3

Percentage of eligible and evaluable patients with MRD < 0.01% among those who had successful MRD determination at the end of Block 3. (NCT00873093)
Timeframe: End of Block 3 (Day 36 of Block 3) of re-induction therapy

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs80
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs63.6

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Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy

The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy. (NCT00873093)
Timeframe: The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.

InterventionPercentage of participants (Number)
Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs72.2
Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs63

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Severe Adverse Events (SAE) Rate.

The proportion of SAE rate among all eligible patients (NCT00873093)
Timeframe: 4 months

Interventionpercentage of participants (Number)
Overall8.2

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Toxic Death Rate

The proportion of toxic death rate among all eligible patients. (NCT00873093)
Timeframe: 4 months

Interventionpercentage of participants (Number)
Overall2.1

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PFS

Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs). (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
High CTC Count4.1
Low CTC Count4.5

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Progression-free Survival (PFS)

Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
Arm A (CE)4.4
Arm B (CE+GDC-0449)4.4
Arm C (CE+IMC-A12)4.6

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Response Rate

Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s). (NCT00887159)
Timeframe: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

InterventionProportion of patients (Number)
Arm A (CE)0.48
Arm B (CE+GDC-0449)0.56
Arm C (CE+IMC-A12)0.50

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Overall Survival (OS)

Overall survival is defined as the time from randomization to death or date of last known alive. (NCT00887159)
Timeframe: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry

Interventionmonths (Median)
Arm A (CE)8.8
Arm B (CE+GDC-0449)9.8
Arm C (CE+IMC-A12)10.1

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PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy.

Response rates for BICE and ICE treatment groups will be assessed by 1999 IWG (CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. (NCT00967369)
Timeframe: Baseline up to 1 year

,
InterventionParticipants (Count of Participants)
PET negativity : Complete Response (CR)PET negativity : Partial Response (PR)PET negativity : Stable Disease (SD)PET positivity : Partial Response (PR)PET positivity : Stable Disease (SD)PET positivity : Progressive Disease (PD)
BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)300412
ICE (Ifosfamide, Carboplatin, Etoposide)641220

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Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Response rates for Bortezomib, Ifosfamide, Carboplatin, Etoposide (BICE) and Ifosfamide, Carboplatin, Etoposide (ICE) treatment groups were assessed by the 1999 International Working Group (IWG)(CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00967369)
Timeframe: From baseline to 3 cycles of treatment

,
InterventionParticipants (Count of Participants)
Overall ResponseComplete Response (CR)Partial Response (PR)Progressive Disease (PD)Stable Disease (SD)
BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)73401
ICE (Ifosfamide, Carboplatin, Etoposide)61503

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Progression Free Survival (PFS) Rate at 12 Months

Progression free survival time is defined as the time interval from treatment start to progression or death due to any cause whichever happens first. Participants will be censored at the last follow-up date, if an event(progression/death) is not observed during the follow-up. (NCT00967369)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Interventionpercentage of participants (Number)
BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)50
ICE (Ifosfamide, Carboplatin, Etoposide)70

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Overall Survival (OS) Rate at 24 Months

Overall Survival is time from date of treatment start until date of death due to any cause or last Follow-up within 24 months. (NCT00967369)
Timeframe: 24 months

Interventionpercentage of participants (Number)
BICE (Bortezomib, Ifosfamide, Carboplatin, Etoposide)70
ICE (Ifosfamide, Carboplatin, Etoposide)89

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. (NCT00977561)
Timeframe: Baseline up to follow-up (90 days post dose)

,
Interventionparticipants (Number)
Adverse EventsSerious Adverse Events
Cisplatin or Carboplatin + Etoposide42
Figitumumab + Cisplatin or Carboplatin + Etoposide54

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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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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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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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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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Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease

"aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999).~GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death~CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD." (NCT01008462)
Timeframe: 1 year post-allograft,

InterventionParticipants (Count of Participants)
Acute Graft-versus-Host-DiseaseChronic extensive Graft-versus-Host-Disease
Treatment (Autologous HCT, Donor HCT)81

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Event-Free Survival (EFS)

Number of patients surviving without relapsed/progressive disease (NCT01008462)
Timeframe: 1 Year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)9

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Number of Patients Who Engrafted

Number of patients with donor engraftment. (NCT01008462)
Timeframe: Day 84 post-allograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)13

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Number of Patients Who Had Infections

Number of patients who had infections. (NCT01008462)
Timeframe: 1 Year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)16

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Number of Patients With Relapsed/Progressive Disease

"Relapse/Progression defined as:~Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies.~Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy ." (NCT01008462)
Timeframe: 1 year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)6

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Overall Survival

Number of patients surviving one year post-autograft (NCT01008462)
Timeframe: 1 year post-autograft

InterventionParticipants (Count of Participants)
Treatment (Autologous HCT, Donor HCT)10

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Non-relapse Mortality (NRM)

Number of patients with non-relapse mortalities. (NCT01008462)
Timeframe: 200 days and 1 Year post-allograft

InterventionParticipants (Count of Participants)
200 days1 Year
Treatment (Autologous HCT, Donor HCT)01

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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative

To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.84
Group 40.82
Group 50.90

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Event Free Survival

Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.81
Group 20.83
Group 30.78

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Safety Analysis and Monitoring of Toxic Death

The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).

Interventionparticipants (Number)
Group 10

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Relapse-free Survival

A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.82
Group 60.83
Group 70.79

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Overall Survival

Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.97
Group 20.97
Group 30.97

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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy

The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.

Interventionparticipants (Number)
Group 172

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Second-event-free Survival

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment

,
InterventionProbability of survival (Number)
Group 10.91
Group 20.94
Group 30.88

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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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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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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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Tumor Response Rate

"Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR)." (NCT01042522)
Timeframe: Median followup time was 48 months.

Interventionproportion of participants (Number)
Arm I (Paclitaxel, Carboplatin)0.43
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)0.54

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Progression-free Survival (PFS)

The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). (NCT01042522)
Timeframe: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

Interventionmonths (Median)
Arm I (Paclitaxel, Carboplatin)27.7
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)19.7

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Overall Survival (OS)

The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported. (NCT01042522)
Timeframe: From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.

InterventionParticipants (Count of Participants)
Arm I (Paclitaxel, Carboplatin)5
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)8

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Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0

Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE. (NCT01055314)
Timeframe: Up to 54 weeks

InterventionParticipants (Number)
IMC-A1289
Temozolomide61

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Response Rate (CR + PR)

Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at > 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR. (NCT01055314)
Timeframe: From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities

InterventionProportion of Participants (Number)
IMC-A120.7667
Temozolomide0.7846

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Event-Free Survival

Probability of no relapse, secondary malignancy, or death after 3 years in the study. (NCT01055314)
Timeframe: 3 years

InterventionProbability (Number)
IMC-A120.1627
Temozolomide0.1919

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Feasibility of the Addition of Cixutumumab to Chemotherapy Determined by Patient Enrollment

Proportion of no Grade 3+ cardiac toxicity. (NCT01055314)
Timeframe: From start to week 26 of therapy

InterventionProportion of Participants (Number)
IMC-A120.9390

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Feasibility of the Addition of Temozolomide to Chemotherapy Determined by Patient Enrollment

Proportion of no Grade 4+ non-hematologic toxicity. (NCT01055314)
Timeframe: From start to week 26 of therapy

InterventionProportion of Participants (Number)
Temozolomide0.7097

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Late Toxicity

Late toxicity is defined as any grade 3 or higher pneumonitis or any grade 4 or higher toxicity which occurs more than 90 days after surgery or completion of treatment. (NCT01076231)
Timeframe: 4.5 Years

InterventionParticipants (Count of Participants)
Arm I0

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Pathologic CR Rate

Pathologic CR rate is defined as the fraction of patients who undergo surgery and have no evidence of disease based on surgical pathology. (NCT01076231)
Timeframe: 90 days

Interventioncomplete response rate percentage (Number)
Arm I21

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Dose-limiting Toxicity

DLT is defined as post-operative mortality (within 30 days of surgery) or any grade 3 or higher pneumonitis or any other grade 4 or higher toxicity which occurs during chemoradiation or within 90 days following the end of treatment, whichever is longer. (NCT01076231)
Timeframe: 90 Days

InterventionParticipants (Count of Participants)
Arm I0

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Number of Participants Deemed Feasible to Receive Intervention

Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible. (NCT01076231)
Timeframe: 90 Days

InterventionParticipants (Count of Participants)
Arm I21

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Percentage of Participants With Kaplan-Meier Curve Event Free Survival (EFS) Constructed With an 95% Confidence Interval

EFS was determined from the date of enrolment in the study until the date of progression, last documentation of disease at or after the last treatment cycle, death, or last follow-up (whichever occurred first). Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)82.1
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)71.0

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Percentage of Participants With Kaplan-Meier Curve Progression Free Survival (PFS) Constructed With an 95% Confidence Interval

PFS is the time interval from start of treatment to documented evidence of disease progression. Disease progression was measured by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: Time of progression or death at 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)82.1
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)71.0

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Kaplan-Meier Progression Free Survival (PFS) Constructed With an 95% Confidence Interval in Participants Who Underwent Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) and/or Computed Tomography (CT) Scans After Cycle 2

The predictive value of early FDG-PET/CT scans on PFS was assessed after cycle 2. PFS is the time interval from start of treatment to documented evidence of disease progression, assessed by the International Workshop Criteria (IWC). Progression is a positive positron emission tomography (PET) finding corresponding to the computed tomography (CT) abnormality (new lesion, increasing size of previous lesion), or a negative PET and a CT abnormality (new lesion, increasing size of previous lesion) of < 1.5 cm (< 1.0 cm in the lungs). Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: After 2 cycles of therapy and prior to cycle 3

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)90.0
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)78.7

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Percentage of Participants Kaplan-Meier Curve Overall Survival (OS) Constructed With an 95% Confidence Interval

OS was calculated from the enrolment date until date of death or last follow-up using the Kaplan Meier. Kaplan-Meier curves were constructed with an 95% confidence interval. (NCT01092182)
Timeframe: At 4 years

Interventionpercentage of participants (Number)
Group A - Low-risk Burkitt Lymphoma (BL)100
Group B - High-Risk Burkitt Lymphoma (BL)84.9
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)76.7

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Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01092182)
Timeframe: Date treatment consent signed to date off study, approximately 102 months and 25 days for Group A, 125 months and 28 days for Group B and 117 months and 29 days for group C.

InterventionParticipants (Count of Participants)
Group A - Low-risk Burkitt Lymphoma (BL)13
Group B - High-Risk Burkitt Lymphoma (BL)87
Group C - High-Risk Diffuse Large B Cell Lymphoma (DLBCL)72

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EFS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 172.7
Arm III: Randomized to Radiation Only in Stratum 162.9

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EFS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy

The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm IV: Nonrandomly Assigned to Arm II Treatment33.6

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EFS With Incomplete Resection After Initial Surgery, Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 241.7
Arm III: Randomized to Radiation Only in Stratum 267.5

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Event-free Survival (EFS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of EFS are calculated from randomization date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy69.2
Arm III: Randomized to Radiation Only63.7

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OS in Children With Incomplete Resection After Initial Surgery Who Then Achieved CR After Induction Chemotherapy or GTR/NTR After Second Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 269.2
Arm III: Randomized to Radiation Only in Stratum 289.5

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OS of Children With Incompletely Resected Ependymoma Who Are Unable to Achieve a Complete Response (CR) by Post-operative Induction Chemotherapy or by Second Surgery and Who Are Non-randomly Assigned to Receive Maintenance Chemotherapy

The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm IV: Nonrandomly Assigned to Arm II Treatment74.0

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OS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation

The Kaplan-Meier estimate of OS is calculated from enrollment date to death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm I: Observation100

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EFS of Children With Supratentorial Classic Ependymoma Who Achieve Complete Resection at First or Second Surgery or Children Who Achieve Complete Response (CR) After Induction Chemo and Who Are Non-randomly Assigned to Observation

The Kaplan-Meier estimate of EFS is calculated from enrollment date to first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of EFS are presented.

Interventionpercentage of participants (Number)
Arm I: Observation66.9

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Overall Survival (OS) in Children Who Have Completely Resected Ependymoma or Achieved CR and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) is conveyed by the hazard ratio and 90.46% stagewise adjusted Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy88.3
Arm III: Randomized to Radiation Only86.9

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OS in Children Who Have Completely Resected Ependymoma at Initial Surgery and Are Treated With Post-radiation Maintenance Chemotherapy or Post-radiation Observation Only.

Kaplan-Meier estimates of OS are calculated from randomization date to death from any cause. The comparison between randomized arms (post-radiation maintenance chemotherapy versus post-radiation observation only) for this stratum is conveyed by the hazard ratio and 95% Wald confidence interval. (NCT01096368)
Timeframe: Up to 10 years after enrollment. 5-year estimates of OS are presented.

Interventionpercentage of participants (Number)
Arm II: Randomized to Radiation With Maintenance Chemotherapy in Stratum 190.7
Arm III: Randomized to Radiation Only in Stratum 186.4

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Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)

Number of patients who achieved ≥5 x 10^6 CD34 cells/kg autologous PBSC collection by apheresis. (NCT01097057)
Timeframe: One Month

InterventionParticipants (Count of Participants)
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)17

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Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg

Number of participants requiring one or two apheresis collection days to reach collection goal. (NCT01097057)
Timeframe: Up to Four Apheresis Days

InterventionParticipants (Count of Participants)
One apheresis collection dayTwo apheresis collection daysThree apheresis collection daysFour apheresis collection days
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)15200

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Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days

Number of participants who did not collect ≥5 x 10^6 CD34 cells/kg in up to four apheresis days (NCT01097057)
Timeframe: Up to Four Apheresis Days

InterventionParticipants (Count of Participants)
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)0

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Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days

Number of patients to collect at least 5 x 10^6 CD34 cells/kg in under 4 apheresis procedures. (NCT01097057)
Timeframe: Up to Four Apheresis Days

InterventionParticipants (Count of Participants)
Treatment (Rituximab, Etoposide, Carboplatin, Ifosfamide)17

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Successful Mobilization and Collection of PBSCs

Count of participants with successful mobilization and collection of PBSCs. Defined as collection of > 2 x 10^6 CD34/kg. The current study will be deemed to be potentially efficacious if the observed rate of success is at least 80%. (NCT01110135)
Timeframe: Within 7 days of apheresis and within 6 weeks of receiving bendamustine hydrochloride

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy and Colony-stimulating Factor)34

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Progression-Free Survival (PFS) at 36-Months for Patients Who Received 4 Cycles of ABVD

The primary objective of this trial is to estimate the 3 year PFS in patients who received 4 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, all patients that received 4 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) are included. (NCT01132807)
Timeframe: 36 Months

Interventionproportion of patients (Number)
Treatment (ABVD: 4 Cycles).91

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Complete Response Rate

A Complete Response (CR) was defined as having the following conditions: 1. A complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. 2. In patients with a PET scan that was positive before therapy, a post-treatment residual mass of any size is permitted as long as it is PET-negative. A Complete Response rate was defined as the number of patients who achieved a CR divided by the number of patients that were eligible for analysis in each group. The CR rate was calculated for patients that completed 4 cycles of ABVD and for patients that completed 2 cycles of ABVD and 2 cycles of BEACOPP and IFRT. (NCT01132807)
Timeframe: Up to 5 years

Interventionproportion of participants (Number)
Treatment (ABVD: 4 Cycles).97
Escalated BEACOPP and Involved Field Radiation Therapy.85

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36 Month Progression Free Survival Rate of Patients Receiving 4 Cycles of ABVD Versus Patients Receiving 2 Cycles of ABVD and 2 Cycles of BEACOPP and Radiation.

All patients received an initial 2-28 day cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) on Days 1 and 15. After the first 2 cycles of ABVD, PET/CT was performed and submitted for central review (cycle 2, days 23-25) and determined whether patients would receive 2 cycles of escalated BEACOPP and involved-field RT (IFRT) or an additional 2 cycles of ABVD. PFS for each patient is measured as the time from registration on trial to the first incident of death or progression. The PFS rate at 36 months is calculated as the number of patients who have a progression-free survival time greater than 36 months divided by the total number of patients that started treatment. For this endpoint, we compare the PFS rate between patients who received 4 cycles of ABVD and patients who received 2 cycles of ABVD and 2 cycles of IFRT. (NCT01132807)
Timeframe: at 36 months

Interventionproportion of participants (Number)
Treatment (ABVD:4 Cycles).91
Escalated BEACOPP and Involved Field Radiation Therapy.67

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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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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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Association Between the Magnitude of mTOR Target Inhibition Post-treatment in Leukemic Blasts and Clinical Response in Patients With High Risk AML Treated With Sirolimus MEC

"Percent change compared between response groups (responder vs nonresponder).~This outcome measure only includes patients who survived to outcome assessment." (NCT01184898)
Timeframe: From pre- to post-treatment

Interventionpercentage change in leukemic blasts (Mean)
Responders (17 pts)Nonresponders (10 pts)
Sirolimus and MEC69-36

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Complete Response

"Complete response is defined as:~Peripheral Blood Counts -Neutrophil count >1 x 109/L.~Platelet count ≥ 100 x 109/L.~Reduced hemoglobin concentration or hematocrit has no bearing on remission status.~Leukemic blasts must not be present in the peripheral blood.~Cellularity of bone marrow biopsy must be > 20% with maturation of all cell lines with < 5% blasts and no Auer rods.~Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present" (NCT01184898)
Timeframe: Within one week of peripheral count recovery but no later than day 42

Interventionparticipants (Number)
Sirolimus and MEC11

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Complete Response in the Absence of Platelet Recovery

"Complete response in the absence of platelet recovery is defined as:~- Bone marrow (<5% blasts) with adequate bone marrow cellularity, no evidence of circulating blasts or extramedullary disease and normalization of peripheral blood counts except for platelets (neutrophil count =1,000/µL)" (NCT01184898)
Timeframe: Within one week of peripheral count recovery but no later than day 42

Interventionparticipants (Number)
Sirolimus and MEC2

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Partial Response

"Partial response is defined as:~Requires that all of the criteria for complete remission be satisfied except that the bone marrow may contain ≥ 5% blasts but < 25% blasts.~A marrow with <5% blasts that contain Auer rods will also be considered a PR" (NCT01184898)
Timeframe: Within one week of peripheral count recovery but no later than day 42

Interventionparticipants (Number)
Sirolimus and MEC3

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Changes in Human Immunodeficiency Virus (HIV) Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months

,
Interventionmedian change in copies per mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH-25-22.5-18-20
Phase II: VR-DA-EPOCH-20-87-200

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Changes in Absolute CD4 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD4 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncell/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-218-190-175-84
Phase I: VR-DA-EPOCH, Dose Level 192-3976169
Phase I: VR-DA-EPOCH, Dose Level 2-9-293131

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Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncopies per milliliter (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 128000
Phase I: VR-DA-EPOCH, Dose Level 1-14518-4517-551160
Phase I: VR-DA-EPOCH, Dose Level 2-12.5000

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Tumor Response (Phase I)

The percentage of participants whose best tumor response is complete response (CR) or partial response (PR). Based on clinical, radiologic (CT), and pathologic criteria, CR requires 1) complete disappearance of all detectable disease and disease-related symptoms if present before therapy, 2) bone marrow aspirate and biopsy to confirm a CR if initially positive or if clinically indicated by new abnormalities in the peripheral blood counts or blood smear, 3) negative PET results, depending on typically, variably, or unknown pre-treatment FDG status, and 4) spleen and/or liver, if considered to be enlarged before therapy on physical examination or CT scan, not being palpable on physical examination and considered normal size by imaging studies, and nodules related to lymphoma disappeared. PR includes 1) ≥50% decrease in sum of product of diameters (SPD), 2) no increase in size of nodes, liver, or spleen, 3) splenic/hepatic nodules regressed by ≥ 50% SPD, 4) no new sites of disease (NCT01193842)
Timeframe: Up to 2 years post treatment

,,
Interventionpercentage of participants (Number)
Complete responsePartial Response
Phase I: Arm C (VR-CHOP) Dose Level 11000
Phase I: VR-DA-EPOCH, Dose Level 183.316.7
Phase I: VR-DA-EPOCH, Dose Level 283.316.7

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Change in CD8 Cell Counts (Phase I)

Differences from baseline (specified follow-up assessment minus baseline) in absolute CD8 counts. (NCT01193842)
Timeframe: Baseline up to 12 months

,,
Interventioncells/mm^3 (Median)
End of cycle 2Treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-CHOP, Dose Level 1-172-81-16128
Phase I: VR-DA-EPOCH, Dose Level 135.5-164.5-56604
Phase I: VR-DA-EPOCH, Dose Level 2-115211275154

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Event-free Survival (EFS) (Phase II)

The percentage of participants surviving without events (relapse or death) one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH75.6
Phase II: DA-R-EPOCH82.2

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Overall Survival (OS) (Phase II)

The percentage of participants surviving one year after starting treatment. (NCT01193842)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH77.6
Phase II: DA-R-EPOCH86.7

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Percentage of Participants With Complete Response (CR) as Assessed by Response Evaluation Criteria in Solid Tumors (Phase II)

"Percentage of participants with complete response as assessed by Response Evaluation Criteria in Solid Tumors (Phase II) according to treatment arm. Participants are planned to be treated for a total of 6 cycles (21 day cycle length). Participants with CR after Cycle 4 will receive two additional cycles of chemotherapy and complete 6 cycles of chemotherapy. Participants who achieve a partial response (PR) only after Cycle 4 may continue on protocol therapy or they may be removed from the study at the AMC discretion of the physician (local Principal Investigator). Participants with stable disease after 4 cycles (i.e., who did not achieve at least a PR) or progressive disease at any time will be removed from study.~In phase II, there are two arms: Vorinostat RPTD+rituximab-DA-EPOCH arm (VR-DA-EPOCH) and Rituximab-DA-EPOCH arm (DA-R-EPOCH)." (NCT01193842)
Timeframe: Up to 6 months

Interventionpercentage of participants (Number)
Phase II: VR-DA-EPOCH67.5
Phase II: DA-R-EPOCH76.2

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Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Interventioncopies per 100uL (Median)
At treatment discontinuation6-month follow-up12-month follow-up
Phase II: DA-R-EPOCH000

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Changes in Human Herpes Virus (HHV)-8 Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

Interventioncopies per 100uL (Median)
12-month follow-up
Phase II: VR-DA-EPOCH0

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Changes in Epstein-Barr Virus (EBV) Viral Load

Differences from baseline (specified follow-up assessment minus baseline) in EBV viral load. (NCT01193842)
Timeframe: Baseline up to 12 months

,,,
InterventionIU/mL (Median)
End of Cycle 2At treatment discontinuation6-month follow-up12-month follow-up
Phase I: VR-DA-EPOCH, Dose Level 10000
Phase I: VR-DA-EPOCH, Dose Level 2-2436.1-1.92-1.92-1.15
Phase II, DA-R-EPOCH0-0.280-2.7
Phase II, VR-DA-EPOCH-0.61-2.9-1.55-0.56

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Pharmacokinetic Clearance (Phase I)

Serial plasma samples for pharmacokinetic analysis were collected at 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion. Doxorubicin, etoposide, and vincristine concentrations were determined using a validated liquid chromatography-tandem mass spectrometry method. The clearance was determined by dividing the drug-infusion rate by the steady-state concentrations, which was the average of the three time points. (NCT01193842)
Timeframe: 24-48, 48-72, and 72-96 hours after the start of the first chemotherapy infusion

,
InterventionLiter/hour (Mean)
DoxorubicinEtoposideVincristine
Phase I: VR-DA-EPOCH, Dose Level 178.63.022.4
Phase I: VR-DA-EPOCH, Dose Level 276.02.416.8

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Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)

The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy. (NCT01193842)
Timeframe: Up to 5 years

,
Interventionpercentage of participants (Number)
DeathLife-threateningSevereModerateMild
Phase II: DA-R-EPOCH20.028.931.117.80
Phase II: VR-DA-EPOCH28.937.820.08.92.2

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Overall Survival

Overall survival is defined as time from enrollment to time of death or last follow-up, within 2 years. (NCT01220297)
Timeframe: 2 years

InterventionDays (Median)
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo405

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Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)

"Assessed as the incidence of grade 2 to 4 acute graft-vs-host disease (GvHD) at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage" (NCT01220297)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo0
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo1

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Acute GvHD (Grade 3 to 4)

"Assessed as the incidence of grade 3 to 4 acute GvHD at Day 100 post-transplant.~Stage of Acute GvHD was assessed as follows.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea > 500 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea >1000 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus~Grade of Acute GvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2 to 3 Liver + No Gut stage" (NCT01220297)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo0
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo1

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Disease-free Survival (DFS)

Assessed as survival without recurrence of disease (NCT01220297)
Timeframe: 2 years

InterventionParticipants (Count of Participants)
GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo0
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo0

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Veno-occlusive Disease (VoD)

Assessed as the incidence of veno-occlusive disease (VoD) at 100 days post-transplant. (NCT01220297)
Timeframe: 100 days post-transplant

InterventionParticipants (Count of Participants)
GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo0
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo1

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Event-Free Survival

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT01231906)
Timeframe: 5 years after enrollment

InterventionPercent Probability (Number)
Arm A (Combination Chemotherapy)77.64
Arm B (Combination Chemotherapy, Topotecan Hydrochloride)78.79

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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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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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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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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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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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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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Percent of Patients Who Proceeded With Transplant

Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR). (NCT01336933)
Timeframe: 168-252 days (4 courses up to 6 courses of treatment)

InterventionParticipants (Count of Participants)
Treatment15

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Overall Survival (OS)

Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause. (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)60

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Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))

"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified" (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)70

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Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment

"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative" (NCT01336933)
Timeframe: 168 days - 252 days (4-6 courses; 42 days per course)

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)52

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Event Free Survival (EFS)

Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause. (NCT01336933)
Timeframe: 2 years

Interventionpercentage of participants analyzed (Number)
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)39

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To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events

Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly. (NCT01336933)
Timeframe: 22 months

Interventionpercentage of participants (Number)
Grade 3-4 anaemiaGrade 3-4 thrombocoytopeniaGrade 3-4 febrile neutropeniaGrade 3-4 mucositisGrade 3-4 sepsisGrade 3-4 increased creatinineGrade 3-4 liver transaminases
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)27121818151212

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Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium

"Determine the doses of mitoxantrone and etoposide that, when combined with CSA and pravastatin, meet minimum standards for both efficacy and toxicity and have the highest efficacy rate among several mitoxantrone and etoposide doses.~Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0." (NCT01342887)
Timeframe: After completion of first 2 courses, up to 22 weeks

Interventiondoses tolerated (Number)
Treatment (Immunosuppression, Enzyme Inhibitor, and Chemo)0

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OS for Patients on Arm C, Cohort 1

The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 1)41.67

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EFS for Patients on Arm C, Cohort 3

The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 3)58.18

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EFS for Patients on Arm C, Cohort 2

The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 2)56.12

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EFS for Patients on Arm C, Cohort 1

The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 1)25.00

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Change in Shortening Fraction

Mean percentage change in shortening fraction from baseline to the end of Induction I will be determined for eligible patients enrolled on Arms A, B and C. (NCT01371981)
Timeframe: Up to 4 weeks

InterventionPercentage change (Mean)
Arm A-1.8445
Arm B-2.6298
Arm C (Cohort 1)-2.2333
Arm C (Cohort 2)-3.6700
Arm C (Cohort 3)-3.4246

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Total Scale Score From Parent-reported Pediatric Quality of Life Inventory Module

"Results represent the total scale scores from the parent report of the PedsQL™ 4.0 Generic Core Scales for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. Scores on a scale is used for a unit of measure." (NCT01371981)
Timeframe: Up to 14 days

InterventionScores on a scale (Mean)
Arm A68.3
Arm B67.8
Arm C (Cohort 1)71.3
Arm C (Cohort 2)61.6

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Event-free Survival (EFS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations

The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm A45.64
Arm B46.95

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Change in Ejection Fraction

The mean percentage change in ejection fraction from baseline to the end of Induction I will be determined for eligible patients enrolled on Arms A, B and C. (NCT01371981)
Timeframe: Up to 4 weeks

InterventionPercentage change (Mean)
Arm A-2.0272
Arm B-2.3453
Arm C (Cohort 1)-7.5000
Arm C (Cohort 2)-5.1997
Arm C (Cohort 3)-3.4624

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Bortezomib Clearance

Median and range of bortezomib clearance during Induction II. (NCT01371981)
Timeframe: Day 8 of Induction II

InterventionLiters/hour/m^2 (Median)
Arm B8.42

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Total Scale Score From Parent-reported Multidimensional Fatigue Scale Module

"Results represent the total scale scores from the parent report of the PedsQL™ Multidimensional Fatigue Scale for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. Scores on a scale is used for a unit of measure." (NCT01371981)
Timeframe: Up to 14 days

InterventionScores on a scale (Mean)
Arm A60.5
Arm B58.1
Arm C (Cohort 1)71.2
Arm C (Cohort 2)48.2

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Total Scale Score From Parent-reported Cancer Module

"Results represent the total scale scores from the parent report of the PedsQL™ 3.0 Cancer Module for timepoint 1 (up to 14 days from start of therapy). Items are reverse-scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Therefore, a higher number is a better outcome. The total score is the sum of all the items divided by the number of items answered on all the scales. Scores on a scale is used for a unit of measure." (NCT01371981)
Timeframe: Up to 14 days

InterventionScores on a scale (Mean)
Arm A66.2
Arm B65.8
Arm C (Cohort 1)74.9
Arm C (Cohort 2)63.7

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Sorafenib Steady State Concentration

Median and range of sorafenib steady state concentration for Induction I. (NCT01371981)
Timeframe: Up to 30 days

InterventionNanogram/Milliliter (Median)
Arm C1090.0

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Relapse Rate for Patients Without High Allelic Ratio FLT3/ITD+ Mutations

Cumulative incidence estimates 3 year relapse rate defined as time from study entry to induction failure or relapse where deaths or secondary malignancies are competing events. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm A46.67
Arm B46.65

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Proportion of Patients Experiencing Grade 3 or Higher Non-hematologic Toxicities and Infections While on Protocol Therapy

The proportion of patients experiencing at least one grade 3 or higher non-hematologic toxicity and infection while on protocol therapy will be estimated along with the corresponding 95% confidence interval determined using a binomial exact method. Toxicity will be assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0). (NCT01371981)
Timeframe: Up to 2 years

InterventionProportion of patients (Number)
Arm A0.8819
Arm B0.9217
Arm C (Cohort 1)0.9167
Arm C (Cohort 2)0.9394
Arm C (Cohort 3)0.9149
Arm D0.0239

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Proportion of High Risk Children Without HR FLT3/ITD+ Converting From Positive MRD at End of Induction I to Negative MRD at the End of Induction II

The proportion of high risk children without HR FLT3/ITD+ converting from positive MRD at end of Induction I to negative MRD at the end of Induction II will be estimated as well as the corresponding 95% confidence interval determined using a binomial exact method. (NCT01371981)
Timeframe: Up to 8 weeks

InterventionProportion of patients (Number)
Arm A0.5000
Arm B0.5238

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Overall Survival (OS) for Patients Without High Allelic Ratio FLT3/ITD+ Mutations

The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm A65.04
Arm B68.45

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OS for Patients on Arm C, Cohort 3

The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 3)61.84

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OS for Patients on Arm C, Cohort 2

The Kaplan-Meier method will be used to estimate 3-year OS, defined as the time from study entry until death. (NCT01371981)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Arm C (Cohort 2)64.77

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Overall Survival

Overall survival is defined as the time from study entry to death or date last known alive. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionmonths (Median)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + BEACOPP + INRTNA

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Complete Response (CR) Rate After Induction Treatment

Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. (NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx1.0

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Proportion of Patients Who Are PET Negative After Induction Treatment

(NCT01390584)
Timeframe: Assessed at end of Cycle 2

Interventionproportion of participants (Number)
Step 1: Induction Tx0.8

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Progression-free Survival Rate

Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. (NCT01390584)
Timeframe: Assessed at 36 months

Interventionproportion of participants (Number)
ABVD + INRTNA
ABVD + BEACOPP + INRTNA

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Progression-free Survival

The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year (NCT01408043)
Timeframe: Up to 1 year post-transplant

InterventionParticipants (Count of Participants)
Treatment (Stem Cell Supermobilization)7

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Overall Survival

Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant (NCT01408043)
Timeframe: Up to 1 year post-transplant

InterventionParticipants (Count of Participants)
Treatment (Stem Cell Supermobilization)7

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Need for Remobilization

"Number of participants that needed remobilization in supermobilizers and normal mobilizers.~Remobilization can be described as follows:~The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as mobilization failure. For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time (remobilization). The need to do a second 'mobilization' attempt is not ideal." (NCT01408043)
Timeframe: Up to 28 days post treatment

InterventionParticipants (Count of Participants)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)00

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Length of Hospital Stay in Super Mobilizers and Normal Mobilizers

Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. (NCT01408043)
Timeframe: Up to 28 days post treatment

Interventiondays (Mean)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)20.722.5

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Collection Using Plerixafor, Etoposide, and Filgrastim

Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers. (NCT01408043)
Timeframe: Within 2 days of apheresis

InterventionParticipants (Count of Participants)
SupermobilizersNormal MobilizersNon mobilizers
Treatment (Stem Cell Supermobilization)7171

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Neutrophil Recovery in Super Mobilizers and Normal Mobilizers

Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers. (NCT01408043)
Timeframe: Up to 28 days post treatment

InterventionK/ul (Mean)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)10.310.2

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Number of Days of Apheresis Required

Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers (NCT01408043)
Timeframe: Up to 28 days post treatment

Interventiondays (Mean)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)1.12.9

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Number of Transfusion Requirements

Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers (NCT01408043)
Timeframe: Up to 28 days post treatment

Interventiontransfusions (Mean)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)3.74.4

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Overall Survival in Supermobilizers and Normal Mobilizers

Percentage of participants who were alive 1 year after transplant (OS) (NCT01408043)
Timeframe: Up to 1 year post-transplant

Interventionpercent of participants (Number)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)100100

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Platelet Recovery in Super Mobilizers and Normal Mobilizers

Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg. (NCT01408043)
Timeframe: Up to 28 days post treatment

Interventionpercentage of change (Mean)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)20.919.8

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Progression-free Survival in Supermobilizers and Normal Mobilizers

Percentage of participants who were alive and free of progression 1 year after transplant (PFS) (NCT01408043)
Timeframe: Up to 1 year post-transplant

Interventionpercent of participants (Number)
SupermobilizersNormal Mobilizers
Treatment (Stem Cell Supermobilization)10082

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Overall Complete Response (CR) and Partial Response (PR) Rate

"Based on the revised response criteria for malignant lymphoma [Cheson 2007]~CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;" (NCT01458366)
Timeframe: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment

InterventionParticipants (Count of Participants)
Phase 272275434Phase 172275434
Complete ResponsePartial ResponseNo response
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)12
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)4
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)8
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)5
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)3

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Phase I: Overall Frequency of Response

"To determine the overall frequency of response--overall response will include all subjects with complete response (CR) and partial response (PR). Based on the revised response criteria for malignant lymphoma [Cheson 2007]~CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;" (NCT01458366)
Timeframe: CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment

InterventionParticipants (Count of Participants)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)7

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Overall Frequency of Response With Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide at Maximum Tolerated Dose (MTD)

To determine the overall frequency of response with combination bendamustine, ofatumumab, carboplatin, and etoposide for refractory or relapsed aggressive B-cell lymphomas. Overall response is determined as cumulative Complete Response (CR) and Partial Response (PR). (NCT01458366)
Timeframe: At 25 days and 3-8 weeks post-treatment

InterventionParticipants (Count of Participants)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)20

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Overall Progression-Free Survival

To determine 1 and 2 year progression-free survival [Cheson 2007] CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen; (NCT01458366)
Timeframe: At 1 and 2 years after completion of treatment; year 2 reported

Interventionmonths (Median)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)5.1

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Overall Proportion of Patients Who Are Able to Undergo Stem Cell Transplant (SCT)

To determine the proportion of patients who are able to undergo stem cell transplant among transplant-eligible patients. Patients can receive SCT after Cycle 2. (NCT01458366)
Timeframe: At 2 years after completion of treatment

InterventionParticipants (Count of Participants)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)12

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Overall Safety and Tolerability of the Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide

"To define safety and tolerability of the combination of ofatumumab, bendamustine, carboplatin and etoposide as measured by the number of dose modifications made to Bendamustine..~Determined through dose modifications for bendamustine according to patient's toxicity levels:~Initial 120 mg/m2 dose decreased to 90 mg/m2~Initial 90 mg/m2 dose decreased to 70 mg/m2~Initial 70 mg/m2 dose decreased to 50 mg/m2~Initial 50 mg/m2 dose decreased to Withdrawn from study" (NCT01458366)
Timeframe: After each cycle (after approximately 3 days, 25 days, and 50 days)

Interventiondose modifications (Number)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)0

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Phase I: Maximum-Tolerated Dose of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (BOCE)

To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade >/= 3 non-hematologic toxicity that persists for 7 days or more. (NCT01458366)
Timeframe: Baseline through 50 days

Interventionmg/m^2 (Number)
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)120

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Total Overall Survival for Transplant vs Non-transplant

1 and 2 year overall survival for those who received Stem Cell Transplant (SCT) versus those who did not receive SCT (NCT01458366)
Timeframe: At 1 and 2 years after completion of treatment; year 2 reported

Interventionmonths (Median)
Did not receive transplantReceived transplant
Bendamustine, Ofatumumab, Carboplatin, and Etoposide (BOCE)7.427.3

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Overall Survival

To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy. (NCT01548573)
Timeframe: 10 years

Intervention ()
Tandem Transplant in MM <12 Mos of Prior Treatment0

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Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.

To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches. (NCT01548573)
Timeframe: 2 years

Intervention ()
Tandem Transplant in MM <12 Mos of Prior Treatment0

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Identification of Drug Resistant Genes

To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation. (NCT01548573)
Timeframe: 5 years

Intervention ()
Tandem Transplant in MM <12 Mos of Prior Treatment0

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Event-Free Survival (EFS)

To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis. (NCT01548573)
Timeframe: 8 years

Intervention ()
Tandem Autologous Stem Cell Transplant0

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Estimation of the Overall Survival (OS) Distribution of Patients With NGGCT Treated With IFR Assessed

Kaplan Meier estimate of the 3-year overall survival (OS) is provided. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. (NCT01602666)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)92.42

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Estimation of the PFS Distribution of Patients With Localized Germinoma Patients and Cerebrospinal Fluid (CSF) Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL

Kaplan Meier estimate of the 3-year PFS rate is provided. PFS is the time interval measured from initiation of treatment until progression or death from any cause or until last follow-up for those who were event free at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study. (NCT01602666)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
hCGbeta <= 50 mIU/mL93.26
50 mIU/mL < hCGbeta <= 100 mIU/mL80.00

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Estimation of the OS Distribution of Patients With Localized Germinoma Patients and CSF Serum hCGbeta of 50 mIU/mL or Less or CSF Serum hCGbeta Greater Than 50 mIU/mL and Less Than or Equal to 100 mIU/mL

Kaplan Meier estimate of the 3-year overall survival (OS) is provided for each group. OS is the time interval measured from enrollment until death from any cause or until last follow-up for those who were alive at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. (NCT01602666)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
hCGbeta <= 50 mIU/mL98.38
50 mIU/mL < hCGbeta <= 100 mIU/mL100

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3-year PFS Rate of Patients With Localized CNS Germinoma Who Were Treated With Reduced Dose Radiation Therapy

"Binomial estimate of the 3-year PFS rate defined as Yes for patients who were followed up per protocol and were progression free at 3-years, and No for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from initiation of treatment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study." (NCT01602666)
Timeframe: 3 years

Interventionpercentage of patients (Number)
Stratum 2 Localized Germinoma86.49

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Estimation of the PFS Distribution of Patients With NGGCT Treated With Involved-field Radiation Therapy (IFR)

Kaplan Meier estimate of the 3-year PFS is provided. PFS is the time interval measured from enrollment until progression or death from any cause or until last follow-up for those who were event free at the time of analysis. Patients who were lost to follow-up or withdrew consent were censored in this analysis. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study. (NCT01602666)
Timeframe: Up to 3 years

Interventionpercentage of patients (Number)
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)87.88

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3-year Progression-free Survival (PFS) Rate of Patients With Nongerminomatous Germ Cell Tumor (NGGCT) Who Were Treated With Reduced Dose Whole Ventricular-field Irradiation

"Binomial estimate of the 3-year PFS rate defined as Yes for patients who were followed up per protocol and were progression free at 3-years, and No for those who either experienced a progression or were lost to follow-up/withdrew from the trial within 3 years from enrollment. Progression was determined by MRI using the COG Guidelines for Measurement of Tumor Size (>25% increase in 2D or >40% in 3D of the product of perpendicular diameters of the target lesion) as well as by tumor marker assessments which were mandatory for this study." (NCT01602666)
Timeframe: 3 years

Interventionpercentage of patients (Number)
Stratum 1 Localized Non-Germinomatous Germ Cell Tumors (NGGCT)83.33

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Overall Response Rate (ORR)

Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Complete response (CR) was defined as disappearance of all target lesions. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall response rate= (CR+PR)/all eligible and treated patients (NCT01642251)
Timeframe: assessed every 6 weeks while on study, then every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration.

Interventionpercentage of patients (Number)
Phase II: Arm D (Veliparib)72
Phase II: Arm E (Placebo)66

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Overall Survival (OS)

Overall survival (OS) is defined as time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method. (NCT01642251)
Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of death. No specific requirements if patient is > 3 years from registration

Interventionmonths (Median)
Phase II: Arm D (Veliparib)10.3
Phase II: Arm E (Placebo)8.9

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Progression Free Survival (Phase II)

Profession free survival (PFS) is defined as time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date they were last known to be alive and progression-free. Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, and progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Median PFS was estimated using the Kaplan-Meier method. (NCT01642251)
Timeframe: Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of first documented progression or death. No specific requirements if patient is > 3 years from registration

,
Interventionmonths (Median)
Overall samplePatients within the male/abnormal LDH stratumPatients not within the male/abnormal LDH stratum
Phase II: Arm D (Veliparib)6.16.26.0
Phase II: Arm E (Placebo)5.55.15.6

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Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start

Neurotoxicity total score was measured by the 11 items in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. Each item was scored from 0-4. The severity of neurotoxicity was measured by the total score of the 11 items, ranged from 0 to 44. Lower values of the FACT/GOG-Ntx neurotoxicity total score indicate higher neurotoxicity. (NCT01642251)
Timeframe: assessed at baseline and 3 months after treatment initiation

Interventionunits on a scale (Mean)
Phase II: Arm D (Veliparib)-0.1
Phase II: Arm E (Placebo)-1.8

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Overall Survival

Survival measured as of day of last contact. Categorized according to criteria recommended by International Working Groups. (NCT01729845)
Timeframe: Up to 5 years

Interventiondays (Median)
Dose Level 2: 7-Days of Decitabine-MEC564

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Duration of Relapse-free Survival (for Patients Achieving CR or CRp)

Categorized according to criteria recommended by International Working Groups. (NCT01729845)
Timeframe: Up to 5 years

InterventionDays (Median)
Dose Level 2: 7-Days of Decitabine-MEC150

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Remission Rate Including CR and CRp

"Complete remission (CR) and Complete remission with incomplete platelet recovery (CRp) categorized according to criteria recommended by International Working Groups:~Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly; hemoglobin level at least 110 g/L, platelet count at least 100x10^9/L, and absolute neutrophil count at least 1.0 x10^9/L. In addition, all 3 blood counts should be no higher than the upper normal limit; Normal leukocyte differential; Bone marrow histologic remission defined as the presence of age-adjusted normocellularity, no more than 5% myeloblasts, and an osteomyelofibrosis grade no higher than 1." (NCT01729845)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Dose Level 2: 7-Days of Decitabine-MEC11

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Most Efficacious and Tolerated Dosage of Decitabine (Period 1)

MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is < 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I) (NCT01729845)
Timeframe: through day 45

,,
InterventionIncidents (Number)
Dose-limiting toxiticiesComplete RemissionComplete Remission, incomplete PLT recoveryComplete Remission, incomplete blood count recoverMorphologic leukemia-free stateResistant DiseaseDeath (among those who received MEC)
Dose Level 1: 5-Days of Decitabine-MEC0120012
Dose Level 2: 7-Days of Decitabine-MEC0511031
Dose Level 3: 10-Days of Decitabine-MEC0320340

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24-month Progression-Free Survival Rate

24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT0.0

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Induction Response

Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Response was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks. (NCT01746173)
Timeframe: Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).

Interventionproportion of patients (Number)
CHOEP + High Dose Therapy + Auto SCT.60

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Proportion of Patients Who Are Adherent to Chemotherapy

Patients who did not miss any doses of chemotherapy (NCT01775475)
Timeframe: Up to 18 weeks

InterventionParticipants (Count of Participants)
Arm I (CHOP)4
Arm II (Oral Chemotherapy)3

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Change in Absolute CD4 Count From Baseline to Post-treatment

Change in absolute CD4 count from baseline to post-treatment (visit 6) (NCT01775475)
Timeframe: From baseline to 18 weeks

Interventioncells per mm^3 (Mean)
Arm I (CHOP)-41.3
Arm II (Oral Chemotherapy)203.3

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Number of Patients Who Complete Treatment

Number of patients who complete chemotherapy treatment. (NCT01775475)
Timeframe: Up to 18 weeks

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)1

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Overall Response Rate

Overall response is complete or partial response as defined by response definitions of the 2014 International Conference on Malignant Lymphoma Imaging Working Group (i.e. Lugano classification). Complete response is the disappearance of all lesions with no new lesions detected. Partial response is >=50% decrease in the sum of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites and no new sites of disease. (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)1

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Overall Survival

Proportion of participants who survived 2 years (NCT01775475)
Timeframe: Up to 24 months

InterventionProportion of participants (Number)
Arm I (CHOP)0
Arm II (Oral Chemotherapy)0

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Participants Who Experienced an Adverse Event

Number of participants who experienced an adverse event (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)4
Arm II (Oral Chemotherapy)3

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Progression-free Survival

Proportion of participants who survived without disease progression at 2 years (NCT01775475)
Timeframe: Up to 24 months

Interventionproportion (Number)
Arm I (CHOP)0
Arm II (Oral Chemotherapy)0

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Proportion of Patients Who Are Adherent to Antiretroviral Therapy

Number of patients who did not miss any of their doses of antiretroviral therapy (NCT01775475)
Timeframe: Up to 24 months

InterventionParticipants (Count of Participants)
Arm I (CHOP)3
Arm II (Oral Chemotherapy)3

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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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Progression-free Survival

Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

Interventionmonths (Median)
EGFR: Erlotinib21.1
EGFR: No Erlotinib9.2
ALK: Crizotinib14.7
ALK: No CrizotinibNA

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Number of Patients With Grade 3-5 Adverse Events

Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionParticipants (Count of Participants)
EGFR: Erlotinib0
EGFR: No Erlotinib0
ALK: Crizotinib0
ALK: No Crizotinib0

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Percentage of Patients With Complete or Partial Response

Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

Interventionpercentage of participants (Number)
EGFR: Erlotinib50.0
EGFR: No Erlotinib26.7
ALK: Crizotinib66.7
ALK: No Crizotinib75.0

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Overall Survival

Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: ErlotinibNA
EGFR: No Erlotinib35.9
ALK: CrizotinibNA
ALK: No CrizotinibNA

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Local-regional Progression-free Survival

Progression is defined using the RECIST guideline v1.1 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 regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: Erlotinib25.7
EGFR: No ErlotinibNA
ALK: Crizotinib14.7
ALK: No CrizotinibNA

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Distant Progression-free Survival

Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination. (NCT01822496)
Timeframe: From randomization to study termination. Maximum follow-up was 39.0 months

InterventionMonths (Median)
EGFR: ErlotinibNA
EGFR: No Erlotinib35.9
ALK: CrizotinibNA
ALK: No Crizotinib20.1

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Median Progression Free Survival (mPFS)

PFS is defined as the time from the start of DPACE to the date of first documentation of disease progression as assessed by the International Myeloma Working Group response criteria or death due to any cause. Progression is defined using the International Myeloma Working Group response criteria, an increase of greater than or equal to 25% from the lower response value. (NCT01849783)
Timeframe: From the start of DPACE for all participants who have had at least one day of protocol treatment. Up to 6 years.

Interventionmonths (Median)
Autologous Stem Cell Transplant76.4

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Mean Change in Quality-Of-Life Indicators Post-Transplant

Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement. (NCT01849783)
Timeframe: Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.

Interventionscore on a scale (Mean)
Change in Physical Functioning at Pre-MaintenanceChange in Physical Functioning at Maintenance Cycle 6Change in Physical Functioning at Maintenance Cycle 12Change in Physical Functioning at Maintenance Cycle 18Change in Physical Functioning at Maintenance Cycle 24Change in Role Functioning at Pre-MaintenanceChange in Role Functioning at Maintenance Cycle 6Change in Role Functioning at Maintenance Cycle 12Change in Role Functioning at Maintenance Cycle 18Change in Role Functioning at Maintenance Cycle 24Change in Emotional Functioning at Pre-MaintenanceChange in Emotional Functioning at Maintenance Cycle 6Change in Emotional Functioning at Maintenance Cycle 12Change in Emotional Functioning at Maintenance Cycle 18Change in Emotional Functioning at Maintenance Cycle 24Change in Cognitive Functioning at Pre-MaintenanceChange in Cognitive Functioning at Maintenance Cycle 6Change in Cognitive Functioning at Maintenance Cycle 12Change in Cognitive Functioning at Maintenance Cycle 18Change in Cognitive Functioning at Maintenance Cycle 24Change in Social Functioning at Pre-MaintenanceChange in Social Functioning at Maintenance Cycle 6Change in Social Functioning at Maintenance Cycle 12Change in Social Functioning at Maintenance Cycle 18Change in Social Functioning at Maintenance Cycle 24Change in Global Health Status at Pre-MaintenanceChange in Global Health Status at Maintenance Cycle 6Change in Global Health Status at Maintenance Cycle 12Change in Global Health Status at Maintenance Cycle 18Change in Global Health Status at Maintenance Cycle 24Change in Distress Symptoms at Pre-MaintenanceChange in Distress Symptoms at Maintenance Cycle 6Change in Distress Symptoms at Maintenance Cycle 12Change in Distress Symptoms at Maintenance Cycle 18Change in Distress Symptoms at Maintenance Cycle 24Change in Side Effects of Treatment at Pre-MaintenanceChange in Side Effects of Treatment at Maintenance Cycle 6Change in Side Effects of Treatment at Maintenance Cycle 12Change in Side Effects of Treatment at Maintenance Cycle 18Change in Side Effects of Treatment at Maintenance Cycle 24
Autologous Stem Cell Transplant1.3-0.61.15.44.67.48.74.47.06.08.75.51.45.88.30.4-4.6-5.1-6.0-3.6-1.02.7-4.90.8-1.55.40.2-3.1-0.13.46.25.95.73.85.3-3.3-0.7-5.1-2.4-2.7

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Percentage of Participants Able to Complete Full Course Therapy

Percentage of participants able to complete the full course of therapy. (NCT01849783)
Timeframe: Up to 6 years

InterventionParticipants (Count of Participants)
Autologous Stem Cell Transplant24

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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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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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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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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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Overall Response Rate (PR + CR)

Overall response rate (CR and PR) after 3 cycles of C R ICE in patients age of 18 to 75 with relapsed/refractory CD20-positive DLBCL treated with rituximab-based immunochemotherapy (e.g., R-CHOP, R-EPOCH, R-HyperCVAD, etc.) induction. Response was based on a Modified Cheson Criteria with Complete response (CR): All lesions with a longest diameter ≤ 15 mm or short axis ≤ 10 mm (Not palpable during the clinical examination, No visible nodule on imaging, And disappearance of all non-nodal target lesions Or in case of hypermetabolic disease on the baseline PET scan, negative PET scan whatever the appearance of lesions on CT) and Partial Response (PR): ≥ 50 % of sum of the products of the diameters (SPD) of target lesions or in the case of hypermetabolic lesions on the baseline PET scan, persistence of at least one PET-positive site without progression of other lesions on CT (≥ 50 % of SPD of target lesions (or longest diameter if a single nodule) No clinically enlarged liver or spleen) (NCT01959698)
Timeframe: The time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented, assessed up to 12 weeks

Interventionpercentage of participants (Number)
Treatment (Carfilzomib, Rituximab, Chemotherapy)66

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MTD Defined as the Dose of Carfilzomib Added to Standard R-ICE Chemotherapy Which, if Exceeded, Would Put the Patient at an Undesirable Risk of Medically Unacceptable Dose-limiting Toxicities (Phase I)

(NCT01959698)
Timeframe: 28 days

Interventionmg/m2 (Number)
Dose Level 1: Carfilzomib 10mg/m2(d1-2; d8-9)NA
Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)NA
Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)NA
Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)NA
Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)NA
Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)NA
Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)NA

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Complete Response Rate According to the International Working Group Response Criteria as Reported by the Revised Cheson Criteria

Efficacy rates were estimated using simple relative frequencies. Complete response rate after 3 cycles of C R ICE in patients age of 18 to 75 with relapsed/refractory CD20-positive DLBCL treated with rituximab-based immunochemotherapy (e.g., R-CHOP, R-EPOCH, R-HyperCVAD, etc.) induction. Response was based on a Modified Cheson Criteria with Complete response (CR): All lesions with a longest diameter ≤ 15 mm or short axis ≤ 10 mm (Not palpable during the clinical examination, No visible nodule on imaging, And disappearance of all non-nodal target lesions Or in case of hypermetabolic disease on the baseline PET scan, negative PET scan whatever the appearance of lesions on CT) and Partial Response (PR): ≥ 50 % of sum of the products of the diameters (SPD) of target lesions or in the case of hypermetabolic lesions on the baseline PET scan, persistence of at least one PET-positive site without progression of other lesions on CT (≥ 50 % of SPD of target lesions (or longest diameter if a si (NCT01959698)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Treatment (Carfilzomib, Rituximab, Chemotherapy)48

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Overall Survival

The estimated distributions of overall survival will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed. It is assumed a priori that any drop out times will be non-informative in terms of the censoring mechanism. Groups defined by levels of categorical or dichotomized numeric demographic/baseline variables will be compared in regards to time-to-event distributions using the log-rank test. Cox proportional hazards model regression will be utilized for multivariate analyses. (NCT01959698)
Timeframe: From the start of treatment until death for any reason, assessed up to 5 years

Interventionmonths (Median)
Treatment (Carfilzomib, Rituximab, Chemotherapy)22.6

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Toxicity of the Addition of Carfilzomib to R-ICE at the MTD, Assessed by the CTEP Version 4.0 of the NCI CTCAE

Count of participants that experienced serious adverse events assessed by the CTEP version 4.0 of the NCI CTCAE (NCT01959698)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Dose Level 1: Carfilzomib 10mg/m2(d1-2; d8-9)2
Dose Level 2: Carfilzomib 15mg/m2(d1-2; d8-9)0
Dose Level 3: Carfilzomib 20mg/m2(d1-2; d8-9)0
Dose Level 4: Carfilzomib 20mg/m2(d1-2); 27mg/m2(d8-9)1
Dose Level 5: Carfilzomib 20mg/m2(d1-2); 36mg/m2(d8-9)1
Dose Level 6: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)3
Expansion Cohort: Carfilzomib 20mg/m2(d1-2); 45mg/m2(d8-9)4

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Progression-free Survival

The estimated distributions of progression-free survival will be obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed. It is assumed a priori that any drop out times will be non-informative in terms of the censoring mechanism. Groups defined by levels of categorical or dichotomized numeric demographic/baseline variables will be compared in regards to time-to-event distributions using the log-rank test. Cox proportional hazards model regression will be utilized for multivariate analyses. (NCT01959698)
Timeframe: Up to 5 years

Interventionmonths (Median)
Treatment (Carfilzomib, Rituximab, Chemotherapy)15.2

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Time to Engraftment (Neutrophil)

Time from the date of the transplant to the date of neutrophil engraftment. (NCT01969435)
Timeframe: Assessed up to day 30

Interventiondays (Median)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)10

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Relapse Free Survival

(NCT01969435)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)0

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Progression-free Survival Rate (PFS)

(NCT01969435)
Timeframe: 1 year

Interventionpercentage of participants (Median)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)70

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Progression-free Survival (PFS) Rate

PFS - Time from start of treatment to the time of progression or death, whichever occurs first. (NCT01969435)
Timeframe: 6 months

Interventionpercentage of participants (Median)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)84

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Overall Survival (OS) Rate

(NCT01969435)
Timeframe: Median follow-up 15.4 months (range 4.7-24.6)

Interventionpercentage of participants (Number)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)10

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Disease-free Survival

Percentage of patients who survive without any signs or symptoms of cancer at 2 years. (NCT01969435)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)64

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Efficacy as Measured by Response Rates

"The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.~Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma" (NCT01969435)
Timeframe: Up to Day 100

Interventionpercentage of participants (Number)
Complete responsePartial responseStable diseaseProgressive disease
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)844012

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Time to Engraftment (Platelet)

Time from the date of transplant to the date of platelet engraftment. (NCT01969435)
Timeframe: Assessed up to day 100

Interventiondays (Median)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)19

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Disease-free Survival

Percentage of patients who survive without any signs or symptoms of cancer at 1 year. (NCT01969435)
Timeframe: 1 year

Interventionpercentage of participants (Number)
Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)70

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Prognostic Significance of Minimal Residual Disease

Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as >10 NCN at baseline. (NCT01979536)
Timeframe: Baseline up to progressive disease, relapse, or death, assessed up to 2 years

InterventionPercentage of patients (Number)
MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy)89
MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy)52.6
MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy)85.6
MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy)58.1

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Event Free Survival (EFS)

The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens. (NCT01979536)
Timeframe: Time from study entry until progressive disease, relapse, or death, assessed up to 2 years

InterventionPercentage of patients (Number)
Arm BV (Brentuximab Vedotin, Combination Chemotherapy)78.8
Arm CZ (Crizotinib, Combination Chemotherapy)76.8

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Occurrence of Grade 3+ Non-hematologic Adverse Events

Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm. (NCT01979536)
Timeframe: Up to 60 months

InterventionPercentage of patients (Number)
Arm BV (Brentuximab Vedotin, Combination Chemotherapy)80.6
Arm CZ (Crizotinib, Combination Chemotherapy)87.9

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Percentage of Patients With Responses at 189 Days

The percentage of patients with complete response (CR) at the end of induction (~189 days) was reported and presented with the associated exact 95% confidence interval. (NCT02017964)
Timeframe: 189 days from start of treatment

InterventionPercentage of patients (Number)
All Eligible Patients (Combination Chemotherapy)92.0

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Overall Survival (OS)

Overall Survival (OS) is defined as the time from diagnosis to death from any cause, or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's, as the data are not mature to 72 months. (NCT02017964)
Timeframe: Assessed up to 72 months, reported at 2 years from diagnosis

Interventionpercent probability (Number)
All Eligible Patients (Combination Chemotherapy)92.0

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Event-free Survival (EFS)

Event-free survival (EFS) is defined as the time from diagnosis to the earliest of disease progression/recurrence, second malignancy or death from any cause, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's. (NCT02017964)
Timeframe: 2 years from diagnosis

Interventionpercent probability (Number)
All Eligible Patients (Combination Chemotherapy)52.0

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Progression-free Survival (PFS)

Progression-free survival (PFS) is defined as the time interval from diagnosis to the earliest of disease progression/recurrence or death from any cause, or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's. (NCT02017964)
Timeframe: 2 years from diagnosis

Interventionpercent probability (Number)
All Eligible Patients (Combination Chemotherapy)52.0

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Percentage of Patients With Responses at 273 Days

The percentage of patients with complete response (CR) at the end of therapy (~273 days) was reported and presented with the associated exact 95% confidence interval. (NCT02017964)
Timeframe: 273 days from start of treatment

InterventionPercentage of patients (Number)
All Eligible Patients (Combination Chemotherapy)88.0

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Overall Survival (OS) of HR and IR Relapse Patients

OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization

Interventionpercentage of participants (Number)
Arm A (HR and IR Control)58.40
Arm B (HR and IR Blinatumomab)71.33

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Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients

DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization

Interventionpercentage of participants (Number)
Arm C (LR Control)58.94
Arm D (LR Blinatumomab)67.00

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Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients

DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization

Interventionpercentage of participants (Number)
Arm A (HR and IR Control)39.04
Arm B (HR and IR Blinatumomab)54.44

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Overall Survival (OS) of LR Relapse Patients

OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization

Interventionpercentage of participants (Number)
Arm C (LR Control)88.29
Arm D (LR Blinatumomab)90.37

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Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)

Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 (NCT02112916)
Timeframe: 3 years

,
InterventionPercentage of participants (Number)
Isolated CNS RelapseIsolated Bone Marrow RelapseCombined Bone Marrow Relapse
AALL0434 T-ALL Patients2.23.01.8
AALL1231 T-ALL Patients3.61.41.3

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Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase

Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCT02112916)
Timeframe: 3 years from start of therapy by patient

InterventionPercentage of participants (Number)
Total Patients78.0

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Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients

EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
Arm A (Combination Chemotherapy)81.7
Arm B (Combination Chemotherapy, Bortezomib)85.1

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EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond

EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
VHR T-LLy (CR/PR)0

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EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)

EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
AALL1231 T-ALL Patients88.3
AALL0434 T-ALL Patients88.8

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EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3

EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years

InterventionPercentage of participants (Number)
VHR T-ALL MRD Undetectable25.0
VHR T-ALL MRD Detectable88.9

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The Remission Rate for Participants With High-risk Myeloma

Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. (NCT02128230)
Timeframe: from baseline to either death or study completion for each subject (up to approximately 48 months)

InterventionParticipants (Number)
Total Therapy 5B0

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Percentages of Patients With Early Response Defined as no Slow Responding Lesions (SRL) and no Progressive Disease (PD) at Any Disease Sites Determined by Positron Emission Tomography (PET) Per Deauville Criteria Through Central Review

The percentages of patients (with available PET scan) with no SRL and no PD will be compared between the two randomized arms to see if brentuximab vedotin in the chemotherapy backbone of doxorubicin hydrochloride, vincristine sulfate, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) arm has a higher rate of early response compared to doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide (ABVE-PC) arm. Two-sample Z test of proportions at 1-sided alpha level of 0.05 will be used for these comparisons. (NCT02166463)
Timeframe: After 42 days of chemotherapy

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)80.7
ARM II (Bv-AVEPC)81.2

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Percentages of Patients Experiencing Grade 3+ Peripheral Neuropathy Assessed by Modified Balis Scale

"The percentages of patients experiencing grade 3+ peripheral neuropathy assessed by the treating clinician using the modified Balis scale. The Modified Balis scale of Pediatric Neuropathy allows clinicians to assign a score for sensory or motor neuropathy symptoms separately. Scores range from 1 to 4 with 1 being the least symptomatic state and 4 indicating a severe debility. The percentages of patients (with a score >/=3) will be compared between the 2 arms by two-sample Z test at 1-sided alpha level of 0.05." (NCT02166463)
Timeframe: From the enrollment of the patient to the time of analysis or the last follow-up; an average of 3.6 years.

InterventionPercentage of patients (Number)
Arm I (ABVE-PC)5.5
ARM II (Bv-AVEPC)6.7

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Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death

Primary analysis will be based 1-sided log rank test comparison of EFS curves between the 2 randomized arms per intention-to-treat principle. Progression is defined as an ≥50% increase of in the product of the perpendicular diameters of any of the involved nodes or nodal masses or focal organ lesions in sites that were persistently PET positive; or recurrent PET positive lesions (Deauville 4, 5) in sites that had previously been PET negative regardless of change of size, as was the development of new PET avid measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Relapse is defined in patients who achieved a prior CR but subsequently has an increase of ≥50% of the PPD in prior nodal or extranodal sites in a recurrently PET positive lesion(s), or the development of new measurable lesion(s) >1.5cm in any axis, or new sites of assessable disease. Second malignancy is defined based on report of a cancer that is not considered to be classic Hodgkin Lymphoma. (NCT02166463)
Timeframe: Up to 48 months after the last enrollment

Interventionpercentage of participants (Number)
Arm I (ABVE-PC)82.5
ARM II (Bv-AVEPC)92.1

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Maximum Tolerated Dose of Brentuximab Vedotin That Can be Combined With Ifosfamide, Carboplatin, and Etoposide Chemotherapy

Will be defined as the dose at which =< 1 of 6 patients experience a dose-limiting toxicity. Dose-limiting toxicity will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT02227199)
Timeframe: Up to 28 days following the second course of chemotherapy, approximately 70 days

Interventionmg/kg (Number)
Treatment (Brentuximab, Ifosfamide, Carboplatin, Etoposide)1.5

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2 Year Overall Survival

(NCT02227199)
Timeframe: Up to 2 years from initiation of study therapy.

InterventionParticipants (Count of Participants)
Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)3
Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)3
Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)37

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Percentage of Patients That Achieve a Complete Remission Following Study Treatment

(NCT02227199)
Timeframe: 3 weeks following the completion of chemotherapy

InterventionParticipants (Count of Participants)
Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)3
Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)3
Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)26

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2 Year Progression-free Survival

(NCT02227199)
Timeframe: Up to 2 years from initiation of therapy.

InterventionParticipants (Count of Participants)
Phase I: Dose Escalation, Dose Level 1 (Brentuximab 1.2mg/kg, Ifosfamide, Carboplatin, Etoposide)2
Phase I: Dose Escalation, Dose Level 2 (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)3
Phase II: Dose Expansion (Brentuximab 1.5mg/kg, Ifosfamide, Carboplatin, Etoposide)33

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Frequency of Toxicity-events

The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event. (NCT02306161)
Timeframe: Up to 202 days

InterventionReporting Periods (Number)
Regimen A (VDC/IE)10
Regimen B (VDC/IE + Ganitumab)27

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Event-free Survival

Estimated 5-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. (NCT02306161)
Timeframe: 5 years after enrollment

Interventionpercent probability of participants (Number)
Regimen A (VDC/IE)30.88
Regimen B (VDC/IE + Ganitumab)30.4

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Overall Survival

Time from study enrollment to death or last patient contact. (NCT02306161)
Timeframe: 5 years after enrollment

InterventionPercent Probability (Number)
Regimen A (VDC/IE)44.93
Regimen B (VDC/IE + Ganitumab)48.19

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Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level

"Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per PFS-4, Yes and PFS-4, No have been reported. As per assessment of investigator based on RECIST v1.1, PFS-4, Yes= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, PFS-4, No=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose." (NCT02432274)
Timeframe: Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)

Interventionpercent change (Mean)
C2D1: FGF 19 (PFS-4, Yes)C2D1: FGF 19 (PFS-4, No)C3D1: FGF 19 (PFS-4, Yes)C3D1: FGF 19 (PFS-4, No)C2D1: FGF 21 (PFS-4, Yes)C2D1: FGF 21 (PFS-4, No)C3D1: FGF 21 (PFS-4, Yes)C3D1: FGF 21 (PFS-4, No)C2D1: VEGF (PFS-4, Yes)C2D1: VEGF (PFS-4, No)C3D1: VEGF (PFS-4, Yes)C3D1: VEGF (PFS-4, No)
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^248.7109.947.3194.5-14.9134.355.017.0119.9124.264.323.2

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Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level

"Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per PFS-4, Yes and PFS-4, No have been reported. As per assessment of investigator based on RECIST v1.1, PFS-4, Yes= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, PFS-4, No=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose." (NCT02432274)
Timeframe: Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)

Interventionpercent change (Mean)
C2D1: FGF 19 (PFS-4, Yes)C2D1: FGF 19 (PFS-4, No)C4D1: FGF 19 (PFS-4, Yes)C4D1: FGF 19 (PFS-4, No)C2D1: FGF 21 (PFS-4, Yes)C2D1: FGF 21 (PFS-4, No)C4D1: FGF 21 (PFS-4, Yes)C4D1: FGF 21 (PFS-4, No)C2D1: VEGF (PFS-4, Yes)C2D1: VEGF (PFS-4, No)C4D1: VEGF (PFS-4, Yes)
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2172.178.3237.791.970.27.2256.2-1.587.995.884.3

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Cohort 2A: Number of Participants With Best Overall Response (BOR)

BOR was defined as the best response of CR or PR for >4 weeks or SD for >=7 weeks recorded from the start of the treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. (NCT02432274)
Timeframe: From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable Disease
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2010

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Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4

Progression free survival at Month 4 (PFS-4) rate was defined as the percentage of participants who were alive and without PD at Month 4 after the first dose of study drug, based on RECIST v1.1, using a binomial proportion with corresponding 95% confidence interval (CI). PD: >= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of >=5 mm. Appearance of >=1 new lesions also considered PD. (NCT02432274)
Timeframe: At Month 4

Interventionpercentage of participants (Number)
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^232.1
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^266.7

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Cohorts 1, 2B, 3A, and 3B: Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a BOR of CR or PR for >4 weeks or SD for >=7 weeks as assessed by investigator based on RECIST v1.1, recorded from start of study treatment until PD or death whichever occurred first. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. 95% CI of the ORR were calculated according to Clopper and Pearson method. (NCT02432274)
Timeframe: From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Interventionpercentage of participants (Number)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^20
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^20
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^20
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^26.7
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^228.6
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^20
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^216.7

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Cohorts 1, 2A, 2B, 3A and 3B: Time to Progression (TTP)

TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method. (NCT02432274)
Timeframe: From first dose of study drug until PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Interventionmonths (Median)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^23.7
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^26.3
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^25.5
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^25.5
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^23.0
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^27.1
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^212.0
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^26.9

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Cohorts 1, 2A, 2B, 3A and 3B: Progression-free Survival (PFS)

PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of PD or date of death, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method. (NCT02432274)
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Interventionmonths (Median)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^23.7
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^26.3
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^25.5
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^25.5
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^23.0
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^27.1
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^212.0
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^26.9

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib

In acceptability questionnaire, participants were asked to answer the overall acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell and how does it feel in the mouth. Overall acceptability was answered in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. Overall acceptability was the overall acceptance for taste, appearance, smell, and the feeling in mouth. In this measure, number of participants have been reported per their overall acceptability responses. (NCT02432274)
Timeframe: Cycle 1 Day 1 (Cycle length=28 days for Cohorts 1, 2A, 2B; Cycle length=21 days for Cohorts 3A, 3B)

,,,,,,,
InterventionParticipants (Count of Participants)
Super GoodReally GoodGoodMay be Good or May be BadBadReally BadSuper Bad
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^20000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^20010010
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^20000001
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^20000000
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^20000000
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^20010000
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^20011110
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^20010000

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Cohorts 1, 2A, 2B, 3A and 3B: Overall Survival (OS)

OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. Participants who are lost to follow-up and those who are alive at the date of data cutoff were censored at the date the participant was last known to be alive (or the data cutoff date). 95% CI of median were calculated according to Brookmeyer and Crowley method. (NCT02432274)
Timeframe: From first dose of study drug until death (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Interventionmonths (Median)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^28.1
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^27.4
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^27.7
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^26.1
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^210.0
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^213.6
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2NA
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2NA

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Who Experienced Disease Control

Participants were defined as having disease control if they had a BOR of CR or PR for >4 weeks, or SD (minimum duration from first dose to SD >=7 weeks) or if participants had a BOR of CR or Non-CR/Non-PD (minimum duration from first dose to Non-CR/Non-PD >=7 weeks) per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (target/non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest SOD. Non-CR/Non-PD: persistence of 1 or more non-target lesions, maintenance of tumor marker level above the normal limits. (NCT02432274)
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

InterventionParticipants (Count of Participants)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^22
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^25
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^25
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^21
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^216
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^25
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^211
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^214

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Experienced Clinical Benefit

Participants were defined as having clinical benefit if they had a BOR of CR or PR for >4 weeks or durable SD (lasting >=23 weeks) or if participants had a BOR of CR or durable Non-CR/Non-PD (lasting >=23 weeks) as per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target/non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. Non-CR/Non-PD:persistence of 1 or more non-target lesions and maintenance of tumor marker level above the normal limits. (NCT02432274)
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

InterventionParticipants (Count of Participants)
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^20
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^23
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^24
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^21
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^27
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^24
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^25
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^28

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Cohorts 1, 2A, 2B, 3A and 3B: Duration of Response (DOR)

DOR was defined as time in months from the first documentation confirmed CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. 95% CI for the median were calculated according to Brookmeyer and Crowley method. (NCT02432274)
Timeframe: First documentation of CR/PR until first documentation of PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

Interventionmonths (Median)
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^21.9
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^24.6
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2NA
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2NA

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Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)

OR was defined as participants with best overall response (BOR) of CR or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. For OR, the BOR was defined as the best response (CR or PR for >4 weeks) recorded from the start of the treatment until PD or death whichever occurred first. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. (NCT02432274)
Timeframe: From date of first dose of study drug until first documentation of PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)

InterventionParticipants (Count of Participants)
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^21

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Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)

BOR: best response of CR or PR for >4 weeks or SD for >=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Not evaluable (NE) means BOR of NE or SD of <7 weeks duration. Unknown means no data were available on the case report form. (NCT02432274)
Timeframe: From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)

,,,,,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseNot Evaluable or Unknown
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^200210
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^200522
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^200442
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^202320
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2001022
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^203942
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^20213123

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Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib

Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days. (NCT02432274)
Timeframe: Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose

,,,,
Interventionnanogram per milliliter (ng/mL) (Mean)
Cycle 1 Day 1: 0.5-4 hoursCycle 1 Day 1: 6-10 hoursCycle 1 Day 15: Pre-doseCycle 1 Day 15: 0.5-4 hoursCycle 1 Day 15: 6-10 hoursCycle 2 Day 1: Pre-doseCycle 2 Day 1: 2-12 hours
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2295.6212.746.9133.4351.858.1502.4
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2134.8281.959.1226.6375.861.6440.7
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^252.5238.096.9191.8413.097.9339.2
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^211.118856.212424759.8102
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2177.4289.467.0168.3322.966.8382.4

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Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib

Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days. (NCT02432274)
Timeframe: Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose

,,
Interventionnanogram per milliliter (ng/mL) (Mean)
Cycle 1 Day 1: 0.5-4 hoursCycle 1 Day 1: 6-10 hoursCycle 2 Day 1: Pre-doseCycle 2 Day 1: 2-12 hours
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2105.2191.951.7205.6
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2111.4148.576.1237.4
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2209.7164.850.4275.3

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Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria

"An aliquot of the urine samples were collected to analyze protein by dipstick method, microscopic examination (if protein was abnormal). The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters of urine protein can be read as negative, Trace, plus (+) 1, +2, +3 and +4 indicating proportional concentrations in the urine sample. The plus sign increases with a higher level of proteins in the urine." (NCT02432274)
Timeframe: Baseline up to approximately 4 years 7 months

,,,,,,,
InterventionParticipants (Count of Participants)
Baseline: Trace, Worst Post baseline: NegativeBaseline: Trace, Worst Post baseline: TraceBaseline: +1, Worst Post baseline: NegativeBaseline: +1, Worst Post baseline: +1Baseline: Negative, Worst Post baseline: NegativeBaseline: +2, Worst Post baseline: NegativeBaseline: +3, Worst Post baseline: NegativeBaseline: +3, Worst Post baseline: +1Baseline: +3, Worst Post baseline: +2Baseline: +3, Worst Post baseline: TraceBaseline: +4, Worst Post baseline: TraceBaseline: +4, Worst Post baseline: +1Baseline: Negative, Worst Post baseline: TraceBaseline: Negative, Worst Post baseline: +1Baseline: Negative, Worst Post baseline: +2Baseline: Negative, Worst Post baseline: +3Baseline: Trace, Worst Post baseline: +1Baseline: Trace, Worst Post baseline: +2Baseline: Trace, Worst Post baseline: +3Baseline: +1, Worst Post baseline: TraceBaseline: +1, Worst Post baseline: +2Baseline: +1, Worst Post baseline: +3Baseline: Negative, Worst Post baseline: +4Baseline: +1, Worst Post baseline: +4
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2212000000000000000000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2203012111000000000000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2001100110111000000000000
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2000010000000000000000000
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2000000000000071110000100
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2010040000000111200000010
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2010020000000316201101011
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2010041000001571121113100

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Number of participants with TEAEs (serious and non-serious adverse events) and SAEs were reported based on their safety assessments of hematology, clinical chemistry, proximal tibial growth, fecal occult blood, physical examinations, regular measurement of vital signs and electrocardiogram parameter values. (NCT02432274)
Timeframe: From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)

,,,,,,,
InterventionParticipants (Count of Participants)
TEAEsSAEs
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^253
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2117
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^275
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^211
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2117
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2119
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^22016
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^22921

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score

Lansky Performance Play Scale rates a child's activity level for <16 years of age. Scores on scale range from 0 (unresponsive) to 100 ( fully active, normal), where 100=fully active, normal; 90=minor restrictions in physically strenuous activity; 80=active, but tires more quickly; 70=both greater restriction of and less time spent in play activity; 60=up and around, but minimal active play, keeps busy with quieter activities; 50=gets dressed, but lies around much of day, no active play, able to participant in quiet play and activities; 40=mostly in bed, participates in quiet activities; 30=in bed, needs assistance even for quiet play; 20=often sleeping, play entirely limited to very passive activities; 10=no play, does not get out of bed; 0=unresponsive. Higher score indicates more activity and lower indicates less or no activity. (NCT02432274)
Timeframe: Baseline up to approximately 4 years 7 months

,,,,,,,
InterventionParticipants (Count of Participants)
Baseline score:100%, Worst Postbaseline score:90%Baseline score: 70%, Worst Postbaseline score: 60%Baseline score: 80%, Worst Postbaseline score: 60%Baseline score: 100%, Worst Postbaseline score:60%Baseline score: 80%, Worst Postbaseline score: 70%Baseline score: 90%, Worst Postbaseline score: 70%Baseline score: 90%, Worst Postbaseline score: 80%Baseline score:100%, Worst Postbaseline score:100%Baseline score: 80%, Worst Postbaseline score: 40%Baseline score: 70%, Worst Postbaseline score: 80%Baseline score: 80%, Worst Postbaseline score: 80%Baseline score: 100%, Worst Postbaseline score:80%Baseline score: 90%, Worst Postbaseline score: 90%Baseline score: 60%, Worst Postbaseline score: 60%Baseline score: 90%, Worst Postbaseline score: 60%Baseline score: 70%, Worst Postbaseline score: 70%Baseline score: 90%, Worst Postbaseline score:100%Baseline score: 100%, Worst Postbaseline score:70%Baseline score: 80%, Worst Postbaseline score: 50%
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^23000000000000000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^20111111100000000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^20010001011110100000
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^20000000100000000000
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^21010000000210000010
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^21000300001001001000
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^20000000500202000000
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^21010011000204111101

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Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores

KPS: compare effectiveness of medicine for disease and assess outcomes in participants. KPS Scores: recorded on 11 point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100%), where 0=Dead; 10=moribund, fatal processes progressing rapidly; 20=very sick, hospital admission necessary, active supportive treatment necessary; 30=severely disabled, hospital admission is indicated although death not imminent; 40=disabled, requires special care/assistance; 50=requires considerable assistance/frequent medical care; 60=requires occasional assistance, but is able to care for personal needs; 70=cares for self, unable to carry normal activity or active work; 80=normal activity with effort, some signs of disease; 90=able to carry on normal activity, minor signs of disease; 100=normal no complaints, no evidence of disease. Lower score, worse survival for most serious illnesses. (NCT02432274)
Timeframe: Baseline up to approximately 4 years 7 months

,,,,,,,
InterventionParticipants (Count of Participants)
Baseline score: 100%, Worst Postbaseline score:80%Baseline score: 100%, Worst Postbaseline score:90%Baseline score: 70%, Worst Postbaseline score: 70%Baseline score: 90%, Worst Postbaseline score: 70%Baseline score: 80%, Worst Postbaseline score: 80%Baseline score: 90%, Worst Postbaseline score: 60%Baseline score:100%, Worst Postbaseline score:100%Baseline score: 100%, Worst Postbaseline score:70%Baseline score: 90%, Worst Postbaseline score: 80%Baseline score: 90%, Worst Postbaseline score: 90%
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^21000000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^20100000000
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^20000000000
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^20000001000
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^20100011000
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^20010000000
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^22200001211
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^22211101013

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12-month PFS (Progression Free Survival) of Treatment With Ixazomib in Combination With DA-EPOCH-R (Phase II)

12-month PFS will be defined as the percentage of patients alive and progression free 12 months from start of therapy. Patients lost to follow up will be censored from last point of contact. PFS was calculated using a Kplan-meier estimation with the probability of patients being progression free at 12 months, presented as the percentage based on this probability. (NCT02481310)
Timeframe: Up to 12 months from initiation of treatment

Interventionprobability (%) of patients alive (Number)
Treatment (Combination Chemotherapy, Rituximab, Ixazomib)75.84

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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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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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Overall Survival

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

InterventionParticipants (Count of Participants)
Treatment (PRIT)2

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Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I)

Non-hematologic toxicities will be evaluated via the ordinal CTC standard toxicity grading. Hematologic toxicity measures of thrombocytopenia, neutropenia, and leukopenia will be assessed using continuous variables as the outcome measures (primarily nadir) as well as categorization via CTC standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. (NCT02561273)
Timeframe: Up to 6 cycles of treatment (approximately 5 months)

,
InterventionParticipants (Count of Participants)
grade 3,4 neutropeniagrade 3, 4 anemiagrade 3, 4 thrombocytopeniagrade 3,4 neutropenia fevergrade 3, 4 diarrheagrade 3, 4 hyperglycemiagrade 3, 4 hypokalemiagrade 3, 4 hypotensiongrade 3, 4 hyperbilirubinemiagrade 3, 4 mucositisgrade 3,4 nauseagrade 3,4 vomiting
10 mg Lenalidomide Participants532400000000
15 mg Lenalidomide Participants433022111221

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Overall Survival

The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT02561273)
Timeframe: Time from registration to death due to any cause, assessed up to 1 year

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)89

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Progression-free Survival

The distribution of PFS will be estimated using the method of Kaplan-Meier. The PFS rate at 2 years will be estimated. A 2-year PFS rate of 60% will be considered of interest. (NCT02561273)
Timeframe: Time from registration to progression or death due to any cause, assessed up to 2 years

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)55

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Overall Response Rate

The ORR will be estimated by the total number of patients who achieve a PR or CR at the end of six cycles of treatment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true ORR will be calculated. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)69

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Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP

MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) (Phase I) within the first cycle of study treatment. (NCT02561273)
Timeframe: 21 days

Interventionmilligrams (Number)
Treatment (Combination Chemotherapy, Lenalidomide)10

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Complete Response Rate (Phase II)

A success is defined to be an objective status of CR after completion of 6 cycles of treatment. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. A 95% confidence interval for the true overall CR rate will be calculated according to the method of Duffy and Santner. (NCT02561273)
Timeframe: Up to the completion of course 6 (18 weeks)

Interventionpercentage of participants (Number)
Treatment (Combination Chemotherapy, Lenalidomide)49

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Number of Participants With Adverse Events Graded According to CTC (Phase II)

"The toxicity profile will be further assessed based on phase II patients. Overall toxicity incidence of maximum tolerated dose level of the Intent to treat (ITT) group of subjects is summarized.~39 subjects were dosed with 10 mg dose of Lenalidamide as the ITT group." (NCT02561273)
Timeframe: Up to 1 year

InterventionParticipants (Count of Participants)
grade 3,4 neutropeniagrade 3, 4 leukopeniagrade 3, 4 anemiagrade 3, 4 thrombocytopeniagrade 3, 4 lymphopeniagrade 3, 4 febrile neutropeniagrade 3, 4 diarrheagrade 3, 4 Peripheral sensory neuropathygrade 3, 4 fatiguegrade 3, 4 nauseagrade 3, 4 anorexiagrade 3, 4 vomitinggrade 3, 4 mucositis oralgrade 3, 4 Rash maculo-papulargrade 3, 4 hypotensiongrade 3, 4 back pain
Treatment (Combination Chemotherapy, Lenalidomide)2725171718153211111111

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Clinical Response to Crenolanib With Standard Salvage Chemotherapy

To determine the response rate to crenolanib. Complete remission (CR) response criteria include a post-baseline bone marrow (BM) biopsy or aspiration % blasts <5%, absolute neutrophil count (ANC) >1×10^9/L and platelet count >100×10^9/L. CRi response included all CR criteria met, except participant did not have either platelet recovery or ANC recovery. CRh response included all CR criteria met, except subject only has partial platelet recovery and ANC recovery. Complete CR (CRc) response includes all subjects who achieve a CR, CRi and CRh. Partial Response (PR) response included a decrease of ≥50% in % blasts in the BM aspirate or biopsy from baseline but >5%. Morphologic Leukemia-Free State (MLFS) response included ≤5% in % blasts in the BM aspirate or biopsy. (NCT02626338)
Timeframe: 1 year

,,,
InterventionParticipants (Count of Participants)
Composite complete remission (CR+CRh+CRi)MLFSClinical benefit (CRc+PR+MLFS)
All Subjects737
Arm A: HAM Chemotherapy323
Arm B: FLAG-Ida Chemotherapy404
Arm C: MEC Chemotherapy010

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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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Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate

"Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable.~When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed." (NCT03023046)
Timeframe: Within 4 cycles of study therapy

InterventionParticipants (Count of Participants)Participants (Count of Participants)
MFC-72545885MFC-72545886CMR72545885HTS-72545885HTS-72545886
Achieve within 4 cyclesNot achieved within 4 cycles
Ph+ Subjects20
Ph- Subjects9
Ph+ Subjects11
Ph+ Subjects17
Ph+ Subjects8
Ph- Subjects6
Ph+ Subjects16
Ph- Subjects16

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Overall Survival

Alive at 2 years after enrollment (NCT03023046)
Timeframe: Up to 2 years

InterventionPercentage of Participants (Number)
Treatment (Chemotherapy)70

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Number of Participants With Morphological Complete Response Rate

Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL. (NCT03023046)
Timeframe: Within 4 cycles of study therapy

InterventionParticipants (Count of Participants)
Ph+ Subjects27
Ph- Subjects20

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Number of Participants With Adverse Events

Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0. (NCT03023046)
Timeframe: Within 28 days of the last dose of the study drugs

InterventionParticipants (Count of Participants)
Treatment (Chemotherapy)44

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Event-free Survival

Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause. (NCT03023046)
Timeframe: Up to 2 years

InterventionPercentage of Participants (Number)
Treatment (Chemotherapy)32

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Overall Survival at 1 Year

Overall survival (OS) was measured from enrollment to death from any cause. OS was estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. (NCT03113500)
Timeframe: The time from enrollment to death from any cause assessed up to 1 year.

Interventionpercentage of survival probability (Number)
Treatment (CHEP-BV)91

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Complete Response (CR) Rate After Cyclophosphamide, Doxorubicin, Etoposide, Prednisone, and Brentuximab Vedotin (CHEP-BV) Induction Therapy

CR rate was estimated by the proportion of evaluable patients achieving CR after CHEP-BV induction therapy, along with the 95% exact binomial confidence interval. (NCT03113500)
Timeframe: Up to the end of the CHEP-BV treatment

Interventionpercentage of response rate (Number)
Treatment (CHEP-BV)79

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Progression-free Survival (PFS)

"PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurs first. Patients who have not experienced an event of interest by the time of analysis will be censored at the date they are last known to be alive and progression-free.~Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression was defined as appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm." (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Interventionmonths (Median)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)5.5
Arm B (Cisplatin/Carboplatin and Etoposide; CE)4.9

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Overall Survival (OS)

OS is defined as the time from maintenance randomization until death of any cause. (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until off treatment or end of observation. Then every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months.

Interventionmonths (Median)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)11.2
Arm B (Cisplatin/Carboplatin and Etoposide; CE)8.1

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Response Rate

"Best overall response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Response was defined as complete response (CR) or partial response (PR).~CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." (NCT03382561)
Timeframe: Every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. Thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months

Interventionproportion of participants (Number)
Arm A (Cisplatin/Carboplatin, Etoposide and Nivolumab; CEN)0.77
Arm B (Cisplatin/Carboplatin and Etoposide; CE)0.80

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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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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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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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"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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Frequency of Adverse Events

Frequency and severity of toxicities will be graded with Common Terminology Criteria for Adverse Events (CTCAE), version 5. Toxicities will be summarized as the proportion of patients with such toxicities, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)1

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Overall Survival (OS)

Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds. (NCT04372927)
Timeframe: From study registration to death due to any cause

Interventionmonths (Mean)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)4

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Response Rate

Will be evaluated using the method of Kaplan-Meier. Confidence intervals for median times will be determined using the Brookmeyer-Crowley method. Confidence intervals around landmark times will be determined using Greenwood's formula for the variance and based on a log-log transformation applied on the survival function. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as response. Means and/or medians will be calculated for continuous outcomes. Confidence bounds will be provided for means and quartiles and ranges for median values. All confidence bounds will be presented as 95% bounds. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)0

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Frequency and Severity of Pneumonitis

The primary toxicity of interest is grade 3 or higher pneumonitis. The incidence of grade 3 or worse pneumonitis attributable to treatment will be evaluated and compared against the PACIFIC trial results. All toxicities of all grades will be monitored on study and reported. Binary proportions will be calculated with associated confidence intervals for binary outcomes, such as toxicity. (NCT04372927)
Timeframe: Through study completion (up to 4 months)

Interventionparticipants (Number)
Treatment (Chemotherapy, Durvalumab, Radiation Therapy)1

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Number of Participants Experiencing Grade 3 and 4 Adverse Events

Defined by Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by frequency and magnitude. (NCT04631029)
Timeframe: Up to 30 days

InterventionParticipants (Count of Participants)
Grade 3 Adverse EventsGrade 4 Adverse Events
Dose Level 132

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Number of Participants Who Received 3 or More Cycles of the Combination of Entinostat, Atezolizumab, Carboplatin, and Etoposide

The proportion of participants who received 3 or more cycles of the combination, will be calculated with a 90% confidence interval. (NCT04631029)
Timeframe: Up to cycle 4 (1 cycle = 21 days)

InterventionParticipants (Count of Participants)
Received 3 or more cyclesReceived 1 or 2 cycles
Dose Level 103

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Number of Participants With Dose Limiting Toxicities

The Bayesian optimal interval (BOIN) design will be used to find the MTD based on safety as determined by dose limiting toxicities. (NCT04631029)
Timeframe: Up to 21 days

InterventionParticipants (Count of Participants)
Completed Dose Level 1 without a dose-limiting toxicityExperienced a dose limiting toxicity in Dose Level 1
Dose Level 112

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Progression Free Survival (PFS) Rate

Defined as the proportion of patients alive and without disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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. Will be estimated with a 90% confidence interval. The Kaplan Meier estimator will be used to estimate survival curves. (NCT04631029)
Timeframe: Up to 2 months

InterventionParticipants (Count of Participants)
Alive without Disease ProgressionDeceased by 2 monthsWithdrew by 2 months
Dose Level 1012

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