- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03932318
Recruitment Status Not yet recruiting
First Posted April 30, 2019
Last update posted February 5, 2020
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)
|Experimental: Phase I and Phase II
Lintuzumab-Ac225 will be administered on Day 8 of each cycle for four cycles (unless in the 0.5 μCi/kg or 0.25 μCi/kg cohorts, where there is a potential for an additional four cycles, pending PI and Medical Monitor review). Venetoclax will be taken on Days 1-21 of each cycle for up to 12 cycles. Azacitidine will be administered on Days 1-7 of each cycle for up to 12 cycles. Each cycle is 28 days, with a potential to expand to 42 days to allow for full hematologic recovery.
In the Phase I, patients will be enrolled into the following dose escalation cohorts: 0.50 μCi/kg, 1.0 μCi/kg, and 1.5 μCi/kg. If the 0.50 μCi/kg dose is determined to exceed the MTD, a 0.25 μCi/kg dose will be explored.
400 mg daily will be taken orally on Days 1-21 of a 28-day cycle. There will be a ramp up of venetoclax dosing in the first cycle, with 100 mg administered on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and Day 4 and later. Patients on antifungal azoles should receive one-half these doses, up to a maximum of 200 mg of venetoclax.
75 mg/m2 will be administered on days 1-7 of a 28-day cycle.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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
2. Relapsed disease will be defined as 5% or more blasts in bone marrow seen after
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 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.
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,
3. Have received prior radiation to maximally tolerated levels to any critical normal
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).
Contact: Actinium Pharmaceuticals, Inc. +1-646-677-3878 email@example.com