CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,154 enrolled
Drug / intervention
Cyclophosphamide +12 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • Newly diagnosed B-precursor acute lymphoblastic leukemia
  • WBC ≥50,000/uL for ages 1-9 years
  • Any WBC for ages 10-30 years, OR patients with prior steroid therapy, OR patients with testicular disease
  • Must be eligible for and enrolled on classification study COG-AALL03B1
Key exclusion· 1
  • Down syndrome

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

Search/NCT00075725
NCT00075725Phase 3Completed

High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

Children's Oncology Group·interventional·Posted Jan 13, 2004·Updated Apr 27, 2021

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide, Cytarabine, and 11 other interventions for Acute Lymphoblastic Leukemia and 2 related conditions. Completed, enrolled 3,154 participants across 234 sites in 5 countries.

Detailed Summary

This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, Switzerland, United States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2004
Enrollment StartDec 29, 2003
Primary CompletionDec 31, 2010
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 22.5 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT, SC, or IV

Daunorubicin Hydrochloridedrug

Given IV

Dexamethasonedrug

Given PO or IV

Doxorubicin Hydrochloridedrug

Given IV

Leucovorin Calciumdrug

Given IV

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT or IV

Pegaspargasedrug

Given IM

Prednisonedrug

Given PO or IV

Radiation Therapyradiation

Undergo radiation therapy

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV