Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I/II Study of Venetoclax and Azacitidine and Lintuzumab-Ac225 in Patients With Refractory or Relapsed AML
Verified date | July 2023 |
Source | Actinium Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a multicenter, open label Phase I/II trial. 1. To determine the maximum tolerated dose (MTD) of lintuzumab-Ac225 when given in combination with venetoclax and azacitidine for patients with CD33 positive AML. (Phase I portion) 2. To assess the percentage of patients with CR, CRh, CRi, MLFS or Overall Response (CR + CRh + CRi + MLFS), up to 6 months after the start of treatment without receiving other AML therapies.. (Phase 2 portion)
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed acute myeloid leukemia 2. 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. 3. White blood cell (WBC) count < 10 x 109/L; a. Use of hydroxyurea, prior to Cycle 1 and during Cycles 1 and 2, is permitted to lower the WBC count in the peripheral blood. 4. Age > 18 years. 5. Estimated creatinine clearance = 50 mL/min calculated by the Cockroft-Gault formula. 6. AST and ALT = 3.0 x ULN (unless considered to be due to leukemic organ involvement). 7. Bilirubin = 3.0 x ULN (unless considered to be due to leukemic organ involvement). 8. Eastern Cooperative Oncology Group (ECOG) Performance Status = 2. Exclusion Criteria: 1. Have acute promyelocytic leukemia (APL). 2. Active CNS leukemia. Patients with symptoms of CNS involvement, particularly those with M4 or M5 subtypes, should undergo lumbar puncture prior to treatment on study to exclude CNS disease. Symptoms include cranial neuropathies, other neurologic deficits, and headache. 3. Have received prior radiation to maximally tolerated levels to any critical normal organ. 4. Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment. 5. Clinically significant cardiac disease. 6. Active, uncontrolled serious infection. 7. Have other non-myeloid malignancy within 2 years of entry (with exceptions). 8. Psychiatric disorder that would preclude study participation 9. Previous solid organ transplant (prior treatment with SCT is allowed but not if patient as GVHD or is still receiving immunosuppression/GVHD therapy). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Actinium Pharmaceuticals |
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 when given in combination with venetoclax and azacitidine for patients with CD33 positive AML | Cycle 1, up to 48 days | |
Primary | Phase II: Overall Response (CR + CRh + CRi + MLFS) | To assess the percentage of patients achieving CR, CRh, CRi, morphologic leukemia-free state (MLFS), or Overall Response (CR + CRh + CRi + MLFS), 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 or CRh or CRi or MLFS | Up to 6 months | |
Secondary | Phase I: OS | Number of patients who died | Phase I: End of 6 months, 12 months, 24 months. | |
Secondary | Phase II: OS | Number of patients who died | Phase II: End of 6 months, 12 months, 24 months | |
Secondary | Phase I and II: DFS | Disease-free survival | Through study completion, up to 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: Lab abnormalities (other than hematologic indices) | Summary of rate of Grade 3/4 lab abnormalities | 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 |
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