CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,929 enrolled
Drug / intervention
sargramostim +17 morebiological
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/NCT00002514
NCT00002514Phase 3Completed

Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission

Eastern Cooperative Oncology Group·interventional·Posted Jan 27, 2003·Updated Jun 18, 2023

In Brief

A Phase 3 clinical trial evaluating sargramostim, asparaginase, and 16 other interventions for Leukemia. Completed, enrolled 1,929 participants across 94 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States

Timeline

Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 7, 1993
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 13.6 yearsPosted 23.4 years ago

Interventions

sargramostimbiological

asparaginasedrug

cyclophosphamidedrug

cytarabinedrug

daunorubicin hydrochloridedrug

dexamethasonedrug

etoposidedrug

imatinib mesylatedrug

leucovorin calciumdrug

mercaptopurinedrug

methotrexatedrug

prednisonedrug

thioguaninedrug

vincristine sulfatedrug

allogeneic bone marrow transplantationprocedure

autologous bone marrow transplantationprocedure

peripheral blood stem cell transplantationprocedure

radiation therapyradiation