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APL93: Timing of CxT and Role of Maintenance

NCT00599937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2008-01-24

No results posted yet for this study

Summary

Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA and the role of maintenance therapy.

Conditions

  • Leukemia, Promyelocytic, Acute

Interventions

DRUG

ATRA

early introduction of ATRA

DRUG

ATRA and or Chemo as maintenance

patients were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally), according to a 2-by-2 factorial design stratified on the initial induction treatment group

Sponsors & Collaborators

  • DRC lille, France

    collaborator UNKNOWN

  • Groupe d'etude et de travail sur les leucemies aigues promyelocytaires

    lead OTHER

Principal Investigators

  • pierre fenaux, mD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-01-31
Primary Completion
1998-12-31
Completion
1998-12-31

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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 NCT00599937 on ClinicalTrials.gov