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ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

NCT01067274 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-12-30

No results posted yet for this study

Summary

A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML).

To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

Conditions

Interventions

DRUG

Vesanoid (ATRA)

45 mg/m2/day in two divided doses from D8 to D28

DRUG

AZACITIDINE (VIDAZA)

75 mg/m2/12h SC from D1 to D5

DRUG

CYTARABINE

Cytarabine : 60 mg/m2/12h SC from D1 to D5

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Acute Leukemia French Association

    lead OTHER

Principal Investigators

  • GARDIN CLAUDE, MD · Acute Leukemia French Association

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-04-30

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT01067274 on ClinicalTrials.gov