Pilot Study of Reduced Venetoclax Exposure

Inclusion Criteria

• •1. Stated willingness to comply with all study procedures and availability for the duration of the study
• •2. Ability to take oral medication and be willing to adhere to the study regimen
• •3. Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
• •1. 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
• •2. Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
• •4. Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
• •5. Consent to be obtained within 10 days (+/- 3 days) of bone marrow biopsy report showing morphological remission. C1D1 of trial to be initiated within 10 days (+/- 7 days) of bone marrow biopsy report showing morphological remission.
• •6. ECOG 0-3
• •7. Intensive treatment ineligible; transplant ineligible or refusal of transplant
• •8. Patient must be able to understand and sign informed consent and additional study documents
• •9. On C1D1 of trial, patient must have count recovery with ANC \>1000, platelets \> 50, Hemoglobin \> 7.7 and without transfusion support for 7 days.
• •10. No growth factor (G-CSF) use in 14 days prior to C1 D1 of trial.