A Randomized Study of Gemtuzumab Ozogamicin (GO) With Daunorubicine and Cytarabine in Untreated Acute Myeloid Leukemia (AML) Aged of 50-70 Years Old
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid Leukemia, patient aged 50 to 70 years
Eligibility Criteria
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
Sites / Locations
- CH
- Hopital Avicenne
- CH
- Hopital Percy
- CHU
- CHU
- CH
- CHU
- CH
- Hopital Edouard Herriot
- CH
- Hopital Pitie-Salpetriere
- Hopital Saint-Louis
- CH
- CHU
- CNLCC
- CH
- Hospital Central
- IGR
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A Daunorubicin and Cytarabine
Arm B Daunorubicin and Cytarabine and Mylotarg
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.
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.