Venetoclax and Lintuzumab-Ac225 in AML Patients

Inclusion Criteria

• Refractory or relapsed AML which will include:
• Refractory disease will be defined as at least 1 prior treatment with no remission.
• Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission.
• Patients with AML arising from myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, ts-AML) are also eligible.
• 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
• ECOG ≤ 2
• Estimated creatinine clearance ≥ 50 mL/min
• AST and ALT ≤ 3.0 x ULN
• Bilirubin ≤ 3.0 x ULN

Exclusion Criteria

• Active CNS Leukemia.
• Known HIV infection or known hepatitis B or hepatitis C infection (with a detectable viral load).
• Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
• Have received prior radiation to maximally tolerated levels to any critical normal organ.
• Clinically significant cardiac disease.
• Active, uncontrolled serious infection.
• Have other non-myeloid malignancy within 2 years of entry (with exceptions).
• Psychiatric disorder that would preclude study participation
• Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Actinium Pharmaceuticals Inc

• Primary ID LIN-AC225-AML02
• Secondary IDs NCI-2019-02582
• Clinicaltrials.gov ID NCT03867682