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Clinical Trials in the USA / NCT04150887
Active, not recruiting Phase 1

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

NCT04150887 · tracked via the Priya Life Science USA tracker
Sponsor
OncoVerity, Inc.
Phase
Phase 1
Started
2019-12-23
Last updated
2026-05-12

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

Cusatuzumab →Azacitidine →Venetoclax →

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)

Trial sites (23)

FacilityCityRegionStatus
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 Lodz Poland
Instytut Hematologii i Transfuzjologii Warsaw Poland
INSELSPITAL, Universitätsspital Bern Bern Switzerland
Kantonsspital St.Gallen Sankt Gallen Switzerland

On this site

📄 Venclexta (venetoclax) drug profile →

More OncoVerity, Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT04150887 on ClinicalTrials.gov ↗ ← All trials in the USA