AML003 (R/R)
Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (Devimistat) in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) Therapy and Control Sub-groups: Combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and Combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (≥ 50 Years) With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Study treatments
- Arm 1: CPI-613 + HD Cytarabine and Mitoxantrone
- Arm 2: active comparator
- High Dose Cytarabine and Mitoxantrone
- Mitoxantrone, Etoposide and Cytarabine
- Fludarabine, Cytarabine and Filgrastim
Inclusion criteria
- Males and females age ≥ 50 years must have histologically documented AML that is relapsed from, or refractory to, prior standard therapies
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Refractory is defined as failure to achieve CR or CRi following:
- At least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen or persistence of disease on a nadir marrow following at least one cycle of any anthracycline, cytarabine or fludarabine containing induction regimen
- Persistent disease after at least 2 cycles of a hypomethylating agent (azacytidine or decitabine) with or without venetoclax
- Relapse is defined as development of recurrent AML (as described by Döhner et al, 2017)6 after CR or CRi has been achieved with a prior chemotherapy or after disease progression on a hypomethylating agent with or without venetoclax
- ECOG PS 0-2
Exclusion criteria
- Patients who have received cytotoxic chemotherapy treatment for their current relapsed or refractory AML.
Participating sites
- Cliniques Universitaires Saint-Luc