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

Acute Leukemia French Association280 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

280

Conditions

Acute Myeloid Leukemia

Interventions

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (19)

Argenteuil, France

Hopital Avicenne

Bobigny, France

Caen, France

Outcomes

Primary Outcomes

Event Free Survival (EFS)

Time frame: Relapse or death measured from randomization

Secondary Outcomes

CR rate

Time frame: CR after induction

Cumulative incidence of relapse

Time frame: Relapse from CR

Overall Survival

Time frame: Survival from randomization

Safety of the combination Mylotarg+chemotherapy

Time frame: Duration of study

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

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

Time frame: Duration of study

Data from ClinicalTrials.gov

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