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) (ALFA-0703)

NCT01067274 Phase 3 WITHDRAWN

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). To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

Details

Lead sponsor	Acute Leukemia French Association
Phase	Phase 3
Status	WITHDRAWN
Start date	2010-04

Conditions

• Acute Myeloid Leukemia

Interventions

• Vesanoid (ATRA)
• AZACITIDINE (VIDAZA)
• CYTARABINE

Primary outcomes

• For randomization R1, the primary endpoint is Event-free Survival (EFS) — 2-year EFS
• For randomization R2, the primary endpoint is disease free survival (DFS) — 2-year DFS

Countries

France