CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,377 enrolled
Drug / intervention
Cyclophosphamide +10 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Newly diagnosed B-precursor acute lymphoblastic leukemia with standard-risk features meeting specific criteria for SR-average, SR-low, or SR-high
  • Initial white blood cell count <50,000/µL
  • Age ≥2 years at diagnosis
  • Prior enrollment on AALL03B1 required before enrollment on AALL0331
Key exclusion· 2
  • Overt testicular disease; such patients may be eligible for AALL0232
  • Contraindication to additional asparaginase therapy following Induction excludes from SR-Low study

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

Search/NCT00103285
NCT00103285Phase 3Completed

Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL)

Children's Oncology Group·interventional·Posted Feb 8, 2005·Updated Jun 14, 2021

In Brief

A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Cyclophosphamide, and 9 other interventions for Acute Lymphoblastic Leukemia and Childhood B Acute Lymphoblastic Leukemia. Completed, enrolled 5,377 participants across 236 sites in 5 countries.

Detailed Summary

This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed 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) may kill more cancer cells.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2005
Enrollment StartApr 11, 2005
Primary CompletionDec 30, 2013
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 21.4 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Some patients undergo cranial radiotherapy

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IV or SC

Dexamethasonedrug

Given IV or PO

Doxorubicin Hydrochloridedrug

Given IV or IT

Leucovorin Calciumdrug

Given PO

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IM or IT

Pegaspargasedrug

Given IM

Thioguaninedrug

Given PO

Vincristine Sulfatedrug

Given IV