Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid Leukemia, patient aged 50 to 70 years
Brief 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.
Detailed 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.
Interventions
DRUGconventional chemotherapy (AraC + Daunorubicin),
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.
DRUGMylotarg associated with conventional chemotherapy (AraC + Daunorubicin),
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.
Sponsors
Versailles Hospital
Acute Leukemia French Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival (EFS) | Relapse or death measured from randomization |
Secondary
| Measure | Time frame |
|---|---|
| CR rate | CR after induction |
| Cumulative incidence of relapse | Relapse from CR |
| Overall Survival | Survival from randomization |
| Safety of the combination Mylotarg+chemotherapy | 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) | Duration of study |
| Relationship between minimal residual disease measured on the expression of WT1 gene and relapse of AML. | Duration of study |
Countries
France
Outcome results
None listed