Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, Priming, GM-CSF, Timed-sequential chemotherapy, Prognosis
Eligibility Criteria
Inclusion Criteria:
- A morphologically proven diagnosis of AML according to the WHO classification
- Serum creatinine < 2N; AST and ALT < 2.5N; total bilirubin < 2N (unless related to the underlying disease).
- ECOG performance status 0 to 2.
- Women of child-bearing must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
- Must be able and willing to give written informed consent
Exclusion Criteria:
- Patients with M3-AML. Patient with AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).
- Patient presenting any diagnosis of uncontrolled or metastatic tumor.
- Patients with uncontrolled severe infection,
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
EMA+GM-CSF
EMA without GM-CSF
HD AraC+ GM-CSF
HD-AraC without GM-CSF
Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10. GM-CSF (LeucomaxR): 5 µg/kg/jour IV over 6 hours from day 1 to day 10.
Daunorubicine (CérubidineR) : 80 mg/m2/jour IV over 30 min from day 1 to day 3, AraC (AracytineR) : 500 mg/m2/jour IV from day 1 to day 3, Mitoxantrone (NovantroneR) : 12 mg/m2/jour IV over 30 min from day 8 to 9 AraC (AracytineR) : 500 mg/m2/12h IV over 3 hours from day 8 to day10.
AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5 GM-CSF :5 µg/kg/d IV (6 hours) from day1 to day 5
- AraC (Aracytine) : 3 g/m2/12h IV (3 hours) on days 1, 3 , 5