Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment
choice (TC). Subjects will be randomly assigned in a 1:1 ratio to either guadecitabine or TC.
TC options include the 8 high or low intensity, locally available regimens below; or Best
supportive Care (BSC) alone:
- High intensity (intermediate or high dose cytarabine [HiDAC]; mitoxantrone, etoposide,
and cytarabine [MEC]; or fludarabine, cytarabine, granulocyte colony stimulating factor
[G-CSF], +/- idarubicin [FLAG/FLAG-Ida]).
- Low intensity (low dose cytarabine [LDAC], decitabine, or azacitidine).
- BSC.