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).

View Eligibility Criteria

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)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT04150887

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 23 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Norton Cancer Institute
Louisville Kentucky, 40207, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Roswell Park Cancer Institute
Buffalo New York, 14203, United States
Weill Cornell Medicine
New York New York, 10021, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
University of Pittsburgh School of Medicine
Pittsburgh Pennsylvania, 15232, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Vermont
Burlington Vermont, 05401, United States
Wisconsin Medical Center
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
University of Alberta Hospital
Edmonton Alberta, T6G 2, Canada
University of Toronto
Toronto Ontario, M5G 2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Universitaetsklinik Hamburg-Eppendorf
Hamburg , 20246, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Klinikum der Universität München
München , 81377, Germany
Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz , 93-51, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
INSELSPITAL, Universitätsspital Bern
Bern , 3010, Switzerland
Kantonsspital St.Gallen
St. Gallen , 9007, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

61

Study ID:

NCT04150887

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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