Acute Myeloid Leukemia Clinical Trial
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia
Summary
The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) are not eligible
Must be ineligible for intensive chemotherapy
De novo or secondary AML
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Previously untreated AML except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m^2) cytarabine during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued greater than or equal to (>=) 24 hours prior to start of study drug. Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued >=24 hours prior to the start of study drug
Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
Exclusion Criteria:
Leukemic involvement of the central nervous system
Eligible for an allogeneic hematopoietic stem cell transplantation at study entry
Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)
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There are 23 Locations for this study
Duarte California, 91010, United States
Louisville Kentucky, 40207, United States
Detroit Michigan, 48201, United States
Buffalo New York, 14203, United States
New York New York, 10021, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
Burlington Vermont, 05401, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H4A 3, Canada
Hamburg , 20246, Germany
Leipzig , 04103, Germany
München , 81377, Germany
Krakow , 31-50, Poland
Lodz , 93-51, Poland
Warszawa , 02-77, Poland
Bern , 3010, Switzerland
St. Gallen , 9007, Switzerland
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