Clinical Trial · NCT03867682

Venetoclax and Lintuzumab-Ac225 in AML Patients

Overview

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)

Sponsor

Actinium Pharmaceuticals, Inc

Phase

Phase 1/2

Contacts

Actinium Pharmaceuticals, Inc. (CONTACT)

actimab@actiniumpharma.com

+1-646-677-3878

Avinash Desai, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT03867682

Eligibility

Inclusion

ECOG ≤ 2
Refractory or relapsed AML which will include:
Bilirubin ≤ 3.0 x ULN
Relapsed disease will be defined as 5% or more blasts in bone marrow seen after remission.
AST and ALT ≤ 3.0 x ULN
Refractory disease will be defined as at least 1 prior treatment with no 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
Estimated creatinine clearance ≥ 50 mL/min

Exclusion

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