Cusatuzumab: Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
Azacitidine: Azacitidine will be administered 75 mg/m\^2 subcutaneously or intravenously.
Venetoclax: Venetoclax will be administered orally and the dose will ramp-up to 400 mg.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Frequency and Severity of Adverse Events (AEs), Laboratory Abnormalities, and Physical Exam Findings as a Measure of Safety — Up to 42 months Frequency and severity of AEs, laboratory abnormalities, and physical exam findings will be reported.
Trial sites (23)
Facility
City
Region
Status
City of Hope
Duarte
California
Norton Cancer Institute
Louisville
Kentucky
Barbara Ann Karmanos Cancer Institute
Detroit
Michigan
Roswell Park Cancer Institute
Buffalo
New York
Weill Cornell Medicine
New York
New York
Memorial Sloan Kettering Cancer Center
New York
New York
University of Rochester
Rochester
New York
University of Pittsburgh School of Medicine
Pittsburgh
Pennsylvania
The University of Texas MD Anderson Cancer Center
Houston
Texas
University of Vermont
Burlington
Vermont
Wisconsin Medical Center
Milwaukee
Wisconsin
Tom Baker Cancer Centre
Calgary
Alberta
University of Alberta Hospital
Edmonton
Alberta
University of Toronto
Toronto
Ontario
McGill University Health Centre
Montreal
Quebec
Universitaetsklinik Hamburg-Eppendorf
Hamburg
Germany
Universitaetsklinikum Leipzig
Leipzig
Germany
Klinikum der Universitaet Muenchen
München
Germany
Szpital Uniwersytecki w Krakowie
Krakow
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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