Venetoclax and Lintuzumab-Ac225 in AML Patients

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a multicenter, open label Phase I/II trial.

1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapsed/refractory AML. (Phase 1 portion)

2. To assess the percentage of patients with CR, CRh, or Overall Response (CR + CRh), up to 6 months after the start of treatment without receiving other AML therapies. (Phase 2 portion)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actinium Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Lintuzumab; Spironolactone; Venetoclax

Criteria

Inclusion 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

Exclusion Criteria:

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. Have received prior radiation to maximally tolerated levels to any critical normal organ.

5. Clinically significant cardiac disease.

6. Active, uncontrolled serious infection.

7. Have other non-myeloid malignancy within 2 years of entry (with exceptions).

8. Psychiatric disorder that would preclude study participation

9. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy).