CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,078 enrolled
Drug / intervention
asparaginase +13 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/NCT00002812
NCT00002812Phase 3Completed
CompareCT.gov

Treatment of Patients With Acute Lymphoblastic Leukemia With Unfavorable Features: A Phase III Group-wide Study

Children's Oncology Group·interventional·Posted Nov 24, 2003·Updated Aug 26, 2013

In Brief

A Phase 3 clinical trial evaluating asparaginase, cyclophosphamide, and 12 other interventions for Leukemia. Completed, enrolled 2,078 participants across 35 sites in 3 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of standard combination chemotherapy treatment with more intensive combination chemotherapy in treating children with acute lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Canada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2003
Enrollment StartSep 1, 1996
Primary CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 22.6 years ago

Interventions

asparaginasedrug

Given IV

cyclophosphamidedrug

Given IV

cytarabinedrug

Given IV

daunorubicin hydrochloridedrug

Given IV

dexamethasonedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

idarubicindrug

Given IV

mercaptopurinedrug

Given IV

methotrexatedrug

Given PO

pegaspargasedrug

Given IV

prednisonedrug

Given PO

thioguaninedrug

Given IV

vincristine sulfatedrug

Given IV

radiation therapyradiation