A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination With Induction Chemotherapy, or Azacitidine and Idarubicin as Salvage Therapy and Idarubicin With Cytarabine or Azacitidine as Maintenance Therapy in Older Patients With Acute Myeloblastic Leukemia (AML)
Induction therapy :
First randomization (R1) at baseline : ATRA versus no ATRA.
Salvage therapy :
No conventional salvage therapy is planned. Patients who will not achieve CR, according to
IWG criteria after induction will be treated with 3 courses of azacitidine and idarubicin
+/- ATRA combination, if eligible for further treatment.
Followed by 3 identical courses and 6 courses of maintenance by azacitidine alone to be
delivered every 28 days, in those patients reaching CR or PR after 3 courses (evaluation of
response from 28 to 56 days from course 3).
Randomization R2: type of maintenance:
Response to induction will be evaluated 2 weeks after myeloid recovery, just before first
consolidation course, due use of to pegfilgrastim, lenograstim or filgrastim during
Responses will be classified according to the Revised Recommendations of the IWG for AML.
Patients in CR only will be subjected to a second randomization R2 as follows 6 courses of
combined chemotherapy, will be delivered as outpatients, ATRA according to R1 randomization.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
For randomization R1, the primary endpoint is Event-free Survival (EFS)
GARDIN CLAUDE, MD
Acute Leukemia French Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
ALFA-0703 Study - P060205