CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 275 enrolled
Drug / intervention
vincristine sulfate +12 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00381680
NCT00381680Phase 3Completed
CompareCT.gov

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

Children's Oncology Group·interventional·Posted Sep 28, 2006·Updated Mar 26, 2024

In Brief

A Phase 3 clinical trial evaluating vincristine sulfate, prednisone, and 11 other interventions for B-cell Childhood Acute Lymphoblastic Leukemia and 3 related conditions. Completed, enrolled 275 participants across 173 sites in 4 countries.

Detailed 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..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Childhood Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Intermediate Risk Recurrent Childhood Acute Lymphoblastic Leukemia
CountriesAustralia, Canada, Switzerland, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2006
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 19.8 years ago

Interventions

vincristine sulfatedrug

Given IV

prednisonedrug

Given PO

doxorubicin hydrochloridedrug

Given IV

pegaspargasedrug

Given IM

cytarabinedrug

Given IT or IV

methotrexatedrug

Given IT or IV

dexamethasonedrug

Given PO

etoposidedrug

Given IV

cyclophosphamidedrug

Given IV

leucovorin calciumdrug

Given IV or PO

filgrastimbiological

Given IV or SC

asparaginasedrug

Given IM

mercaptopurinedrug

Given PO