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A Randomized Study of Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia.

NCT00363025 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2008-02-21

No results posted yet for this study

Summary

In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.

Conditions

Interventions

PROCEDURE

Two post-remission strategies

DRUG

Idarubicin versus daunorubicin

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Acute Leukemia French Association

    lead OTHER

Principal Investigators

  • Herve Dombret, M.D. · Acute Leukemia French Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-11-30
Completion
2006-04-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00363025 on ClinicalTrials.gov