RecruitingPhase 2NCT06384261

A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy

Multicenter, Open-label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients Who Are Not Candidates for Intensive Therapy

Sponsor

OncoVerity, Inc.

Enrollment

120 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

Leukemia, Myeloid, Acute

Summary

The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new drug called cusatuzumab to the standard treatment of venetoclax and azacitidine improves outcomes in people newly diagnosed with acute myeloid leukemia (AML — a fast-growing blood cancer) who are not healthy enough for intensive chemotherapy. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with AML and have not been treated yet - You cannot tolerate intensive chemotherapy (due to age 75+, poor health status, or other health conditions) - Your liver and kidney function meet required levels **You may NOT be eligible if...** - You have a specific type called acute promyelocytic leukemia (APL) - You have cancer that has spread to your brain or spinal fluid - You have had a stem cell transplant - You have active hepatitis B or C - You have severe heart failure - You have received prior AML treatment (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCusatuzumab

CD70 monoclonal antibody

DRUGVenetoclax

BCL-2 inhibitor

DRUGAzacitidine

Hypomethylating agent

Locations(31)

Banner MD Anderson

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

University of California Los Angeles

Los Angeles, California, United States

University of Colorado Health - Anschutz Cancer Pavilion - Anschutz Medical Campus

Aurora, Colorado, United States

Yale School of Medicine

New Haven, Connecticut, United States

AdventHealth Medical Group Blood & Marrow Transplant at Orlando

Orlando, Florida, United States

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Norton Healthcare, Inc.

Louisville, Kentucky, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Hofstra/Northwell Health

Lake Success, New York, United States

Cornell University

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Wake Forest North Carolina

Winston-Salem, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Fred Hutch Seattle Cancer Care Alliance

Seattle, Washington, United States

Medical College of Wisonsin

Milwaukee, Wisconsin, United States

Tom Baker Cancer Center-Alberta Health Services - University of Calgary

Calgary, Alberta, Canada

Stollery Children's Hospital-Walter C Mackenzie Health Sciences Centre - University of Alberta

Edmonton, Alberta, Canada

Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

University of Western Ontario

London, Ontario, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Saskatchewan Cancer Agency - Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Marien Hospital Duesseldorf

Düsseldorf, Germany

Universitaetsklinik Frankfurt

Frankfurt, Germany

Medizinische Hochschule Hanover, Hannover Medical School

Hanover, Germany

Universitaetsklinik um Schleswig-Holstein, UKSH-Campus Kiel

Kiel, Germany

Inselspital Bern

Bern, Switzerland

HFR Fribourg - Hopital Cantonal

Fribourg, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06384261

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