drugset / Trial / NCT01067274
ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)
Phase 3
Withdrawn
Acute Leukemia French Association
Assistance Publique - Hôpitaux de Paris · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2010-04
- Primary completion
- 2016-04
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Cytarabine | Small molecule | 60 mg/m2 | Subcutaneous |
| Subject | Tretinoin | Small molecule | 45 mg/m2 | — |