Venetoclax and Lintuzumab-Ac225 in AML Patients

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Relapsed Adult AML

In brief

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)

Key facts

Study ID

NCT03867682

Run by

Actinium Pharmaceuticals

People needed

38

Starts

2020-01-15

Expected to finish

2024-06-01

Last updated by the study team

2023-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University of California — Los Angeles, California, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.