A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloid Leukemia

Inclusion Criteria

• •* Participants with relapsed/refractory AML (according to European LeukemiaNet 2022 Criteria) after treatment with a Venetoclax-containing regimen.
• •* Participants with MDS, MPN, or MDS/MPN overlap who develop secondary AML after treatment with a Venetoclax-containing regimen.
• •* Prior therapy with hydroxyurea or emergency use of Cytarabine (up to 1 gm total dose) for cytoreduction is allowed.
• •* Prior hematopoietic stem-cell transplant (HSCT) and/or donor lymphocyte infusion (DLI) are allowed if at the time of relapse ≥ 90 days have passed from the date of the last stem cell transplant (90-day duration not required for DLI).
• •* Age ≥ 18 years old.
• •* Eastern Oncology Group (ECOG) performance status of ≤ 2
• •* Participants must agree to take the following reproductive precautions:
• •* Negative urine pregnancy test within one week prior to starting the study therapy for all women of childbearing potential.
• •* Participants who could become pregnant should use effective contraception during therapy and for 6 months after the last dose of study treatments. Participants with partners who could become pregnant should also use effective contraception during therapy and for 6 months after the last dose of study treatments.
• •* Nursing women should discontinue breastfeeding during therapy and for 10 days after the last dose of study treatments.
• •* Adequate organ function as follows:
• •* liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN). Unless liver enzyme abnormalities are suspected by the treating investigator to be due to leukemic infiltration after discussion with the principal investigator (PI).
• •* kidney function (creatinine \< 1.5 x ULN)
• •* Ability to understand the study procedures and requirements. A signed informed consent by the participant or an authorized legal representative is required.