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

Inclusion Criteria

• •1. 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.
• •2. Age ≥ 18 years at the time of consent.
• •3. ECOG Performance Status of ≤ 2 within 28 days prior to registration.
• •4. 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)
• •5. Acute Myeloid Leukemia with a documented IDH1 mutation.
• •6. No more than 2 lines of prior therapy. NOTE: One line of therapy must have contained venetoclax.
• •7. Persisting, non-hematologic and non-infectious toxicities from prior treatment must be Grade ≤ 2. NOTE: Documentation of these criteria is required at screening.
• •8. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.
• •* Renal
• •* Calculated creatinine clearance (Cockcroft-Gault formula will be used to calculate creatinine clearance) ≥ 30 mL/min
• •* Hepatic
• •* Total bilirubin2 ≤ 2× upper limit of normal (ULN); ≤ 3 times ULN in patients with Gilbert Syndrome
• •* Aspartate aminotransferase (AST) ≤ 5 × ULN
• •* Alanine aminotransferase (ALT) ≤ 5× ULN
• •9. Participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment.
• •10. Participants of childbearing potential who are having penile-vaginal intercourse with a person able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. A participant able to father a child who is having penile-vaginal intercourse with a person of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.
• •13. As determined by the investigator or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.