Trial · NCT00381680

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

NCT00381680, Phase 3, Completed, Children's Oncology Group; results first posted 2017-05-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia. Trials, record NCT00381680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381680

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Trial

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

Title: Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
NCT number: NCT00381680
Status: Completed
Phases: Phase 3
Enrollment: 275 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: B-cell Childhood Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions: vincristine sulfate, prednisone, doxorubicin hydrochloride, pegaspargase, cytarabine, methotrexate, dexamethasone, etoposide, cyclophosphamide, leucovorin calcium, filgrastim, asparaginase, mercaptopurine
First posted: 2006-09-28
Last updated: 2024-03-26
Results first posted: 2017-05-12

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Event Free Survival. EFS	3 years after enrollment	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).
Secondary	Frequency and Severity of Adverse Effects	Up to 107 weeks	Percentage of patients who developed at least 1 episode of grade 2 to 4 neuropathy.
Secondary	Gene Expression Profile	Up to 36 months	Percent of unfavorable gene expression profile of early versus late marrow relapse.
Secondary	Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	End of Block 1 (35 days) of Induction therapy	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
Secondary	Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	End of Block 3 (105 days) of Induction therapy	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.
Secondary	Event Free Survival (EFS)	3 years	Percentage of patients who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months.
Secondary	Adjusted Event Free Survival	3 years	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).

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival. EFS	3 years after enrollment	The analysis is limited to eligible patients on regimen A (Standard VCR dosing) who did not undergo SCT.	percentage of participants EFS at 3 yrs3	NUMBER
SECONDARY	Frequency and Severity of Adverse Effects	Up to 107 weeks	The total number of patients for CC or CT genotype is 81 and for high-risk CEP72 genotype is 18. No related by arm data were provided.	percentage of participants	NUMBER
SECONDARY	Gene Expression Profile	Up to 36 months	The data were not collected due to the lack of funds.
SECONDARY	Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	End of Block 1 (35 days) of Induction therapy	This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 1.	percentage of participants	NUMBER
SECONDARY	Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	End of Block 3 (105 days) of Induction therapy	This analysis is limited to all eligible patients with isolated BM or combined BM relapse \>= 36 months and had successful MRD determinations at End Block 3.	percentage of participants	NUMBER
SECONDARY	Event Free Survival (EFS)	3 years	The percentage of patients (pts) who were event free at 3 years among those with isolated BM or combined BM relapse \>= 36 months. Pts with MRD \<0.01% at the end of Block 1 (MRD \< 0.01% BL1); MRD \>= 0.01% at the end of Block 1 (MRD\>= 0.01% BL1); MRD \< 0.01% at the end of Block 3 (MRD \< 0.01% BL3);MRD \>=0.01% at the end of Block 3.	percentage of participants	NUMBER
SECONDARY	Adjusted Event Free Survival	3 years	The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.	adjusted percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group17

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

Outcome	Group	Category	Value	Spread	Units
Event Free Survival. EFS	Regimen A: Standard Vincristine Dosing		66.0	95% Confidence Interval 58.0 to 74.0	percentage of participants EFS at 3 yrs3
Frequency and Severity of Adverse Effects	All Patients	CC or CT genotype	17.3	95% Confidence Interval 10.1 to 27.6	percentage of participants
Frequency and Severity of Adverse Effects	All Patients	High-risk CEP72 genotype (TT at rs924607)	44.4	95% Confidence Interval 22.4 to 68.7	percentage of participants
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	Regimen A		50.8		percentage of participants
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1	Regimen B		41.5		percentage of participants
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	Regimen A		81.4		percentage of participants
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3	Regimen B		88.9		percentage of participants
Event Free Survival (EFS)	Regimen A	MRD < 0.01% BL1	88.5	95% Confidence Interval 80.4 to 96.6	percentage of participants
Event Free Survival (EFS)	Regimen B	MRD < 0.01% BL1	77.3	95% Confidence Interval 59.8 to 94.8	percentage of participants
Event Free Survival (EFS)	Regimen A	MRD >= 0.01% BL1	60.0	95% Confidence Interval 47.6 to 72.4	percentage of participants

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A: Standard Vincristine Dosing	206
Overall Study	STARTED	Regimen B: Randomized High Dose Vincristine Regimen	69
Overall Study	COMPLETED	Regimen A: Standard Vincristine Dosing	81
Overall Study	COMPLETED	Regimen B: Randomized High Dose Vincristine Regimen	19
Overall Study	NOT COMPLETED	Regimen A: Standard Vincristine Dosing	125
Overall Study	NOT COMPLETED	Regimen B: Randomized High Dose Vincristine Regimen	50

Source ClinicalTrials.gov

Adverse events534

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	Regimen A: Standard Vincristine Dosing	51	203	102
other	Anemia	Blood and lymphatic system disorders	Arm B: Randomized High Dose Vincristine Regimen	22	68	40
other	Bone marrow hypocellular	Blood and lymphatic system disorders	Regimen A: Standard Vincristine Dosing	1	203	1
other	Bone marrow hypocellular	Blood and lymphatic system disorders	Arm B: Randomized High Dose Vincristine Regimen	0	68	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Regimen A: Standard Vincristine Dosing	1	203	1
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Arm B: Randomized High Dose Vincristine Regimen	1	68	1
other	Febrile neutropenia	Blood and lymphatic system disorders	Regimen A: Standard Vincristine Dosing	127	203	250
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm B: Randomized High Dose Vincristine Regimen	48	68	89
other	Hemolysis	Blood and lymphatic system disorders	Regimen A: Standard Vincristine Dosing	2	203	2
other	Hemolysis	Blood and lymphatic system disorders	Arm B: Randomized High Dose Vincristine Regimen	0	68	0

1 to 10 of 534Source ClinicalTrials.gov

See all 534 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A: Standard Vincristine Dosing
Total, all-cause mortality	Arm B: Randomized High Dose Vincristine Regimen
Total, other adverse events	Regimen A: Standard Vincristine Dosing	189	203
Total, other adverse events	Arm B: Randomized High Dose Vincristine Regimen	66	68
Total, serious adverse events	Regimen A: Standard Vincristine Dosing	40	203
Total, serious adverse events	Arm B: Randomized High Dose Vincristine Regimen	11	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32001530	DERIVED

Source PubMed

Grants1

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
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons1

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

Comparison
Regimen A: Standard Vincristine Dosing vs Arm B: Randomized High Dose Vincristine Regimen: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00381680

GET https://conductscience.org/api/trials/v1/NCT00381680/events?page=2

API reference For AI assistants