Venetoclax and Lintuzumab-Ac225 in AML Patients

Eligibility Criteria

• 1. Refractory or relapsed AML which will include:
• 1. Refractory disease will be defined as at least 1 prior treatment with no remission.
• 2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission.
• 3. Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible.
• 2. Circulating blast count ≤ 200/μL within 10 days prior to first cycle of treatment. Hydroxyurea should be used to keep the peripheral blast count ≤ 200/μL until the first day of protocol treatment, to the extent that this is possible
• 3. ECOG ≤ 2
• 4. Estimated creatinine clearance ≥ 50 mL/min
• 5. AST and ALT ≤ 3.0 x ULN
• 6. Bilirubin ≤ 3.0 x ULN
• 1. Active CNS Leukemia.
• 2. Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load).
• 3. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
• 4. Secondary refractory AML (e.g., treated for current relapse without achieving remission);
• 5. Have received prior radiation to maximally tolerated levels to any critical normal organ.
• 6. Clinically significant cardiac disease.
• 7. Active, uncontrolled serious infection.
• 8. Have other non-myeloid malignancy within 2 years of entry (with exceptions).
• 9. Psychiatric disorder that would preclude study participation
• 10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).