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NCT Number: NCT00927498

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CH, Argenteuil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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 child bearing potential.
  • Signed informed consent.

Exclusion criteria

  • M3-AML
  • AML following previously know myeloproliferative syndrome.
  • Known central nervous system involvement.
  • Uncontrolled infection
  • Other active malignancy

Treatment and study plan

conventional chemotherapy (AraC + Daunorubicin),

Drug

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Mylotarg associated with conventional chemotherapy (AraC + Daunorubicin),

Drug

Daunorubicin(DNR) induction : 60 mg/m2/day IV (30 min), Days 1,2,3 Daunorubicin (DNR)first consolidation : 60 mg/m2 day 1. Daunorubicin (DNR)second consolidation : 60 mg/m2 day 1 and day 2.

Cytarabine induction :200 mg/m2/day by continuous infusion, Days 1 to 7. Cytarabine (AraC)first and second consolidation: 1g/m2/12h days 1 to 4.

Mylotarg® (GO)induction : 3 mg/m2 IV (2 hours) Days 1, 4, 7. Mylotarg® (GO) First consolidation and Second Consolidation:3 mg/m2 day 1.

Primary outcomes

  1. Event Free Survival (EFS)

    Time frame: Relapse or death measured from randomization

Secondary outcomes

  1. CR rate

    Time frame: CR after induction

  2. Cumulative incidence of relapse

    Time frame: Relapse from CR

  3. Overall Survival

    Time frame: Survival from randomization

  4. Safety of the combination Mylotarg+chemotherapy

    Time frame: Duration of study

  5. Possible predictors of response to Mylotarg: with respect to MDR (multi drug resistance) status, cytogenetics risk groups and mutational status (FLT3, MLL, CEBPa, NPM)

    Time frame: Duration of study

  6. Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML.

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Acute Leukemia French Association

Other

Collaborators

  • Versailles Hospital

Registry information

Official study title

A Phase III Multicentric Randomized Study of the Combination of Repeated Doses of Gemtuzumab Ozogamicin (GO) With Daunorubicin and Cytarabine Versus Daunorubicin and Cytarabine in Untreated Patients With Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old.

Important dates

Study start
2007
Primary completion
2011
Study completion
2013
First posted
Jun 25, 2009
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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