Open Actively Recruiting
Venetoclax and Lintuzumab-Ac225 in AML Patients
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)
- 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
- 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.
- Secondary refractory AML (e.g., treated for current relapse without achieving remission); a. With the exception that single agent FLT3 inhibitors, IDH1/IDH2 inhibitors are allowed for current relapse without achieving remission.
- 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).
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- UCLA Westwood