BCL2i CLAG-M in R/R Acute Myeloid Leukemia

Excluded: TP53 mutation

Must have received: induction chemotherapy — refractory disease: at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction); secondary AML: prior HMA, HMA + venetoclax (>3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy

failure to achieve CR after at least 1 cycle of intensive induction therapy (or 2 cycles of non-intensive induction); Secondary AML arising out of MDS previously treated with HMA, HMA + venetoclax (if > 3 months from venetoclax exposure), and/or 1 cycle of induction chemotherapy

Cannot have received: BCL2 inhibitor (venetoclax)

Exception: venetoclax exposure > 3 months prior to first dose of study therapy

Venetoclax-refractory disease or recent venetoclax exposure < 3 months prior to first dose of study therapy

Cannot have received: high-dose cytarabine-containing regimen (CLAG, FLAG, MEC, CLIA, HAM)

Prior treatment with a high-dose cytarabine-containing regimen (e.g., no prior CLAG/FLAG/MEC/CLIA/HAM, etc.)

Cannot have received: allogeneic stem cell transplant

Exception: allowed if > 3 months prior

Allogeneic stem cell transplant in the past 3 months

Cannot have received: AML-directed therapy

Exception: allowed if >14 days from last therapy or five half-lives, whichever is shorter, not including hydroxyurea

Less than 14 days from last AML-directed therapy or five half-lives, whichever is shorter, not including hydroxyurea