CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 170 enrolled
Drug / intervention
dactinomycin +14 morebiological
Likely dose
Not stated in record
Key inclusion· 6
  • Diagnosis of acute lymphoblastic leukemia (ALL) of B- or T-cell lineage, or Philadelphia chromosome-positive ALL, or lymphoblastic lymphoma, or chronic myelogenous leukemia in lymphoid blast crisis
  • Age 18 years and over
  • Karnofsky performance status 20-100%
  • Left ventricular ejection fraction at least 50%
Key exclusion· 6
  • Prior biologic therapy
  • Prior chemotherapy
  • Prior endocrine therapy
  • Prior radiotherapy

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

Search/NCT00002766
NCT00002766Phase 3Completed

A Phase III Trial Comparing ARA-C/High-Dose Mitoxantrone ("ALL-2') to A Standard Vincristine/Prednisone Based Regimen ('L-20') as Induction Therapy For Adult Patients With Acute Lymphoblastic Leukemia (ALL): The ALL-4 Protocol

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Feb 22, 2016

In Brief

A Phase 3 clinical trial evaluating dactinomycin, sargramostim, and 13 other interventions for Leukemia and Lymphoma. Completed, enrolled 170 participants across 7 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia. PURPOSE: This randomized phase III trial is studying two different chemotherapy regimens and comparing them to see how well they work in treating adults with acute lymphoblastic leukemia, lymphoblastic lymphoma, or chronic myelogenous leukemia.

Study Details

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

Timeline

Phase 3CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 1996
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 15.5 yearsPosted 23.4 years ago

Interventions

dactinomycinbiological

sargramostimbiological

carmustinedrug

cyclophosphamidedrug

cytarabinedrug

daunorubicin hydrochloridedrug

doxorubicin hydrochloridedrug

etoposidedrug

mercaptopurinedrug

methotrexatedrug

mitoxantrone hydrochloridedrug

pegaspargasedrug

prednisonedrug

vincristine sulfatedrug

radiation therapyradiation