DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML (MYLOFRANCE2)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia, First relapsing AML
Eligibility Criteria
Inclusion Criteria:
Patients with a morphologically proven diagnosis of CD33-positive AML and :
- Age ≥ 50 years and ≤ 70 years.
- First relapsing AML with a duration of first CR ≥ 3 and ≤18 months
- ECOG performance status 0 to 3
- Negative serology HIV, HBV and HBC (except post vaccination)
- Serum creatinine ≤ 2N; AST and ALT ≤ 2N; total bilirubin ≤ 2N
- Cardiac function determined by radionuclide 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 diagnosed myelodysplastic syndrome or myeloproliferation
- Known central nervous system involvement with AML
- Prior treatment with HSCT.
- Previous treatment with Anti CD33 antibodies
- Uncontrolled infection
- Other active malignancy
Sites / Locations
- Hopital Avicenne
- CH
- Hopital Percy
- CHU
- CHU
- CH
- Hopital Edouard Herriot
- CH
- St Antoine Hospital
- Hopital Saint-Louis
- CH
- CHU
- CNLCC
- CH
- IGR
Arms of the Study
Arm 1
Experimental
DAUNORUBICINE - ARACYTINE - MYLOTARG -
Adaptive Bayesian method for dose-finding in phase I/II clinical trials based on treatment efficacy and toxicity (Thall, Russel, 1998), with successive patients cohorts and three combined dose levels: DNR 45 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 100 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. DNR 60 mg/m2 IV days 1 to 3 + AraC 200 mg/m2 CI days 1 to 7 + Mylotarg 3mg/m2 IV days 1, 4, 7. Two consolidation courses for CR patients: Amsacrine: 90 mg/m2 IV Day 1 Cytarabine: 1g/m2 twice a day IV Days 1 to 4 Mylotarg: 3 mg/m2 IV Day 1.