Open Actively Recruiting

Venetoclax and Lintuzumab-Ac225 in AML Patients

About

Brief 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)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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).

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Study Stats
Protocol No.
19-000565
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03867682
For detailed technical eligibility, visit ClinicalTrials.gov.