A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old

Last updated: July 10, 2013
Sponsor: Acute Leukemia French Association
Overall Status: Completed

Phase

3

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT00927498
ALFA 0701
  • Ages 50-70
  • All Genders

Study Summary

The main objective of this study is to compare conventional chemotherapy: daunorubicin and the Aracytine and this chemotherapy in combination with the monoclonal antibody used Mylotarg in divided doses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a morphologically proven diagnosis AML and both the two followingcriteria: Age > 50 years and £ 70 years. Not previously treated for their disease.

  • ECOG performance status 0 to 3

  • Negative serology HIV, HBV and HBC (except post vaccination)

  • Serum creatinin inf 2.5N; AST and ALT inf 2.5N; total bilirubin inf 2N

  • Cardiac function determined by radionucleide or echography within normal limits.

  • Negative serum pregnancy test within one week before treatment for women of childbearing potential.

  • Signed informed consent.

Exclusion

Exclusion Criteria:

  • M3-AML

  • AML following previously know myeloproliferative syndrome.

  • Known central nervous system involvement.

  • Uncontrolled infection

  • Other active malignancy

Study Design

Total Participants: 280
Study Start date:
December 01, 2007
Estimated Completion Date:
July 31, 2013

Study Description

Patients with a morphologically proven diagnosis AML and both the two following criteria:

  • Age > 50 years and £ 70 years.

  • Not previously treated for their disease.

Randomization will be centralized by phone :

Arm A chemotherapy with daunorubicin and Aracytine or Arm B Daunorubicin and Aracytine and Mylotarg.

Connect with a study center

  • CH

    Argenteuil, 95107
    France

    Site Not Available

  • Hopital Avicenne

    Bobigny, 93309
    France

    Site Not Available

  • CH

    Caen, 14033
    France

    Site Not Available

  • Hopital Percy

    Clamart, 92141
    France

    Site Not Available

  • CHU

    Creteil, 94010
    France

    Site Not Available

  • CHU

    Dijon, 21034
    France

    Site Not Available

  • CH

    Lens, 62307
    France

    Site Not Available

  • CHU

    Lille, 59037
    France

    Site Not Available

  • CH

    Limoges, 87042
    France

    Site Not Available

  • Hopital Edouard Herriot

    Lyon, 69437
    France

    Site Not Available

  • CH

    Meaux, 77104
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris, 75651
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris,
    France

    Site Not Available

  • CH

    Roubaix, 59100
    France

    Site Not Available

  • CHU

    Rouen, 76038
    France

    Site Not Available

  • CNLCC

    Saint-Cloud, 92210
    France

    Site Not Available

  • CH

    Valenciennes, 59322
    France

    Site Not Available

  • Hospital Central

    Versailles, 78157
    France

    Site Not Available

  • IGR

    Villejuif, 94805
    France

    Site Not Available

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