Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

Inclusion criteria

• ✓. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• ✓. Age ≥ 18 years at the time of consent.
• ✓. ECOG Performance Status of ≤ 2 within 28 days prior to registration.
• ✓. Must have histologically or cytologically documented relapsed and/or refractory Acute Myeloid Leukemia (Refractory is defined as failure to achieve a CR after induction chemotherapy or a minimum of two cycles of HMA plus venetoclax)
• ✓. Acute Myeloid Leukemia with a documented IDH1 mutation.
• ✓. No more than 2 lines of prior therapy. NOTE: One line of therapy must have contained venetoclax.
• ✓. Persisting, non-hematologic and non-infectious toxicities from prior treatment must be Grade ≤ 2. NOTE: Documentation of these criteria is required at screening.
• ✓. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.

Exclusion criteria