drugset / Trial / NCT01067274

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

NCT01067274 ↗

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
—

Outcome

Outcome not reported

Stopped: “Study abandoned”

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Cytarabine Small molecule 60 mg/m2 Subcutaneous
Subject Tretinoin Unknown 45 mg/m2 —