Low-dose AZA, Pioglitazone, ATRA Versus Standard-dose AZA in Patients >=60 Years With Refractory AML
Status:
Terminated
Trial end date:
2020-03-25
Target enrollment:
Participant gender:
Summary
Diagnosis: Acute myeloid leukemia refractory to intensive induction chemotherapy; Age ≥ 60
years, no upper age limit; Study drug: low-dose azacitidine, pioglitazone, ATRA; Safety
Run-In Phase; randomized Phase II, open-label
- Safety Run-In Phase: Based on a 3 + 3 modified design, the tolerable dose of ATRA for
the randomized phase II is defined.
- Phase II: Experimental Arm: low-dose azacitidine, pioglitazone, ATRA; Standard Arm:
standard-dose azacitidine; in both arms patients can receive further cycles (with no
limit to the number given) as long as clinically appropriate