Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

Running, not enrolling · Phase 1

Conditions studied: Leukemia, Myeloid, Acute

In brief

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).

Key facts

Study ID

NCT04150887

Run by

OncoVerity, Inc.

People needed

61

Starts

2019-12-23

Expected to finish

2027-05-15

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• City of Hope — Duarte, California, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Vermont — Burlington, Vermont, United States
• Wisconsin Medical Center — Milwaukee, Wisconsin, United States
• Tom Baker Cancer Centre — Calgary, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• University of Toronto — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• 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 — Lodz, Poland
• Instytut Hematologii i Transfuzjologii — Warsaw, Poland
• INSELSPITAL, Universitätsspital Bern — Bern, Switzerland
• Kantonsspital St.Gallen — Sankt Gallen, Switzerland

Full record on ClinicalTrials.gov

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