Pilot Study of Reduced Venetoclax Exposure

Prior treatment

• Treatment with another investigational drug
• Use of growth factor (G-CSF) within the last 14 days prior to C1D1 of trial treatment.
• Subject has received treatment prior to induction with the following:
  • Prior hypomethylating agent or BCL-2 inhibitor for either AML or MDS other than for induction prior to enrollment.
  • Prior CAR-T cell therapy. iii. Experimental or investigational drug therapy for 14 days prior to study entry leukemia-directed therapies.
• Subject has:
  • Acute promyelocytic leukemia (APL) with t(15;17). ii. Presence of t(9;22) given the potential indication for concurrent tyrosine kinase therapy.
  • Known active CNS involvement with AML.

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to take oral medication and be willing to adhere to the study regimen
• Diagnosed by current WHO or ICC criteria with Acute Myeloid Leukemia and treated for initial induction therapy with one of two regimens:
  • 5-Azacitidine administered subcutaneously at a dose of 75mg/m2/day X 7 days in combination with VEN (21-28 days/cycle)
  • Decitabine administered intravenously at a dose of 20mg/m2/day administered in combination with VEN (21-28 days/cycle)
• Achieving morphological CR/CRi by bone marrow biopsy with \<5% blasts within 3 cycles. See Appendix 2 for definitions.
• ECOG 0-3
• Patient must be able to understand and sign informed consent and additional study documents
• On C1D1 of trial, patient must have count recovery with ANC \>1000, platelets \> 50, Hemoglobin \> 7.7 and without transfusion support for 7 days.