NCT00381680|CompletedPhase 3ResultsDMC

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

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Children's Oncology Group ClinicalTrials.gov

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5 other identifiers

AALL0433NCI-2009-00306COG-AALL0433CDR0000495359U10CA098543

Study Type

interventional

Target

275

Locations

4 countries

Sites

173

Timeline

RegisteredSep 2006

StartedMar 2007

Brief Summary

This randomized phase III trial is studying low-dose vincristine to see how well it works compared with high-dose vincristine when given together with different combination chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways and different doses may kill more cancer cells..

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

275

participants targeted

Target at P50-P75 for phase_3

Geographic Reach

4 countries

173 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed

5 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed

9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 12, 2017

Completed

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

9 years

First QC Date

September 26, 2006

Results QC Date

December 16, 2016

Last Update Submit

March 4, 2024

Conditions

B-cell Childhood Acute Lymphoblastic Leukemia L1 Childhood Acute Lymphoblastic Leukemia L2 Childhood Acute Lymphoblastic Leukemia Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

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).
3 years after enrollment

Secondary Outcomes (6)

Frequency and Severity of Adverse Effects
Up to 107 weeks
Gene Expression Profile
Up to 36 months
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1
End of Block 1 (35 days) of Induction therapy
Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3
End of Block 3 (105 days) of Induction therapy
Event Free Survival (EFS)
3 years
+1 more secondary outcomes

Study Arms (2)

Regimen A: Standard vincristine dosing

ACTIVE COMPARATOR

See detailed description.

Drug: vincristine sulfateDrug: prednisoneDrug: doxorubicin hydrochlorideDrug: pegaspargaseDrug: cytarabineDrug: methotrexateDrug: dexamethasoneDrug: etoposideDrug: cyclophosphamideDrug: leucovorin calciumBiological: filgrastimDrug: asparaginaseDrug: mercaptopurine

Arm B: Randomized High Dose Vincristine regimen

EXPERIMENTAL

See detailed description. Closed to accrual as of 09/2010).