Trial · NCT00408005

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

NCT00408005, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2019-06-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma. Trials, record NCT00408005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00408005

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
NCT number: NCT00408005
Status: Completed
Phases: Phase 3
Enrollment: 1,895 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: T Acute Lymphoblastic Leukemia, T Lymphoblastic Lymphoma
Interventions: Asparaginase, Cyclophosphamide, Cytarabine, Daunorubicin Hydrochloride, Dexamethasone, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Leucovorin Calcium, Mercaptopurine, Methotrexate, Nelarabine, Pegaspargase, Prednisone, Radiation Therapy, Thioguanine, Vincristine Sulfate
First posted: 2006-12-05
Last updated: 2026-06-23
Results first posted: 2019-06-20

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	4 years from randomization at the end of induction	Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Primary	Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)	4 years from randomization at the end of induction	Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event
Primary	Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	4 years from randomization at the end of induction	Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free.
Primary	Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)	4 years from randomization at the end of induction	Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Primary	Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort	4 years from end of induction	Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free.
Secondary	Cumulative Incidence of CNS Relapse for T-ALL by Risk Group	4 years from randomization at the end of induction	Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	4 years from randomization at the end of induction	Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Nelarabine versus No Nelarabine. T-LLY patients are excluded from this analysis. Induction failures non-randomly assigned to Arm IV were excluded from this analysis.	percent probability	NUMBER
PRIMARY	Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)	4 years from randomization at the end of induction	Includes subjects randomized to Nelarabine versus No Nelarabine	percent probability	NUMBER
PRIMARY	Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	4 years from randomization at the end of induction	Includes only T-cell Acute Lymphoblastic Leukemia (T-ALL) patients randomized to Capizzi Methotrexate (CMTX) versus High-Dose Methotrexate (HDMTX). CNS3 patients non-randomly assigned to HDMTX (Arms III and IV) and Induction failures non-randomly assigned to Arm IV were excluded. T-LLY patients are excluded.	percent probability	NUMBER
PRIMARY	Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)	4 years from randomization at the end of induction	Includes subjects randomized to Capizzi Methotrexate versus High-Dose Methotrexate	percent probability	NUMBER
PRIMARY	Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort	4 years from end of induction	Includes T-cell lymphoblastic lymphoma (T-LLy) patients that are standard risk, high risk and induction failures. All Standard risk T-LLy patients only received Arm I. Induction failures were assigned to Arm II.	percent probability	NUMBER
SECONDARY	Cumulative Incidence of CNS Relapse for T-ALL by Risk Group	4 years from randomization at the end of induction	Includes only low risk, intermediate risk and high risk T-cell Acute Lymphoblastic Leukemia (T-ALL) subjects. There were no low risk participants on Arm II and Arm IV. Patients with CNS3, and Induction Failures are excluded from this analysis.	percent probability	NUMBER

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM I (Combination Chemotherapy)	89.01	95% Confidence Interval 83.4 to 94.6	percent probability
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM II (Combination Chemotherapy)	90.53	95% Confidence Interval 85.0 to 96.0	percent probability
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM III (Combination Chemotherapy)	78.07	95% Confidence Interval 71.2 to 84.9	percent probability
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM IV (Combination Chemotherapy)	86.46	95% Confidence Interval 80.6 to 92.4	percent probability
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)	ARM I and ARM III (Combination Chemotherapy)	82.96	95% Confidence Interval 78.4 to 87.5	percent probability
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)	ARM II and ARM IV (Combination Chemotherapy)	88.30	95% Confidence Interval 84.2 to 92.4	percent probability
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM I (Combination Chemotherapy)	91.76	95% Confidence Interval 88.8 to 94.8	percent probability
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM II (Combination Chemotherapy)	90.53	95% Confidence Interval 85.0 to 96.0	percent probability
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM III (Combination Chemotherapy)	86.06	95% Confidence Interval 82.2 to 89.9	percent probability
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)	ARM IV (Combination Chemotherapy)	84.89	95% Confidence Interval 78.0 to 91.8	percent probability

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow112

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Induction	STARTED	T-ALL Induction Therapy	1,596
Induction	STARTED	T-LLy Induction Therapy	299
Induction	STARTED	T-ALL: Capizzi MTX Without Nelarabine	0
Induction	STARTED	T-ALL: Capizzi MTX With Nelarabine	0
Induction	STARTED	T-ALL: High Dose MTX Without Nelarabine	0
Induction	STARTED	T-ALL: High Dose MTX With Nelarabine	0
Induction	STARTED	T-LLy: Capizzi MTX Without Nelarabine	0
Induction	STARTED	T-LLy: Capizzi MTX With Nelarabine	0
Induction	COMPLETED	T-ALL Induction Therapy	1,189
Induction	COMPLETED	T-LLy Induction Therapy	205

1 to 10 of 112Source ClinicalTrials.gov

See all 112 participant flow

Adverse events5,360

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	T-ALL Induction Therapy	57	1,563	60
other	Anemia	Blood and lymphatic system disorders	T-ALL Post Induction Therapy	0	368	0
other	Anemia	Blood and lymphatic system disorders	T-ALL: Capizzi MTX Without Nelarabine	87	372	139
other	Anemia	Blood and lymphatic system disorders	T-ALL: Capizzi MTX With Nelarabine	26	147	37
other	Anemia	Blood and lymphatic system disorders	T-ALL: High Dose MTX Without Nelarabine	93	451	142
other	Anemia	Blood and lymphatic system disorders	T-ALL: High Dose MTX With Nelarabine	25	219	29
other	Anemia	Blood and lymphatic system disorders	T-LLy Induction Therapy	2	285	2
other	Anemia	Blood and lymphatic system disorders	T-LLy Post Induction Therapy	0	80	0
other	Anemia	Blood and lymphatic system disorders	T-LLy: Capizzi MTX Without Nelarabine	23	143	33
other	Anemia	Blood and lymphatic system disorders	T-LLy: Capizzi MTX With Nelarabine	9	62	12

1 to 10 of 5,360Source ClinicalTrials.gov

See all 5,360 adverse events

Adverse event totals30

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	T-ALL Induction Therapy	6	1,563
Total, all-cause mortality	T-ALL Post Induction Therapy	39	368
Total, all-cause mortality	T-ALL: Capizzi MTX Without Nelarabine	26	372
Total, all-cause mortality	T-ALL: Capizzi MTX With Nelarabine	10	147
Total, all-cause mortality	T-ALL: High Dose MTX Without Nelarabine	45	451
Total, all-cause mortality	T-ALL: High Dose MTX With Nelarabine	35	219
Total, all-cause mortality	T-LLy Induction Therapy	0	285
Total, all-cause mortality	T-LLy Post Induction Therapy	8	80
Total, all-cause mortality	T-LLy: Capizzi MTX Without Nelarabine	17	143
Total, all-cause mortality	T-LLy: Capizzi MTX With Nelarabine	5	62

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse event totals

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30138085	DERIVED	PubMed
32552472	DERIVED	PubMed
32813610	DERIVED	PubMed
34302711	DERIVED	PubMed
36603187	DERIVED	PubMed
37556734	DERIVED	PubMed
40533067	DERIVED	PubMed
41592282	DERIVED	PubMed
42085640	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013	NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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