Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Study of Venetoclax and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML
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)
Status | Recruiting |
Enrollment | 38 |
Est. completion date | June 2024 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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. 5. Have received prior radiation to maximally tolerated levels to any critical normal organ. 6. Clinically significant cardiac disease. 7. Active, uncontrolled serious infection. 8. Have other non-myeloid malignancy within 2 years of entry (with exceptions). 9. Psychiatric disorder that would preclude study participation 10. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient has GVHD or is still receiving immunosuppression/GVHD therapy). |
Country | Name | City | State |
---|---|---|---|
United States | University of California | Los Angeles | California |
United States | University of Louisville | Louisville | Kentucky |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Weill Cornell Medicine | New York | New York |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Actinium Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase I: Maximum Tolerated Dose (MTD) of Lintuzumab-Ac225 | To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 added to venetoclax for patients with CD33 positive relapse/refractory AML. | Cycle 1, up to 48 days | |
Primary | Phase II: Overall Response (CR + CRh + CRi) | To assess the percentage of patients with CR, CRh, CRi or Overall Response (CR + CRh + CRi), up to 6 months after the start of treatment without receiving other AML therapies. | Up to 6 months | |
Secondary | Phase I: Overall Response | Number of patients who's overall response is CR, CRh, or CRi | Up to 6 months | |
Secondary | Phase I and II: OS | Number of patients who died | End of 6 months, 12 months, 2 years | |
Secondary | Phase I and II: DFS | Disease-free survival | End of 6 months, 12 months, 2 years | |
Secondary | Phase I and II: Evaluate incidence of AEs and SAEs | Rate of AEs and SAEs, including infusion-related reactions | Through study completion, up to 2 years | |
Secondary | Phase I and II: Evaluate BH3 priming assay results | Summary of assay results | Completion of Cycle 1, estimated 1 month | |
Secondary | Phase I and II: MRD status | Number of patients who are MRD negative | From date of first dose until the date of first documented response, first assessment at 6 months | |
Secondary | Phase I and II: Lab abnormalities (other than hematologic indices) | Summary of rate of Grade 3/4 lab abnormalities | Through study completion, up to 2 years |
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