Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4) LISAFTOCLAX

What's the purpose of this trial?

A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

1. Newly diagnosed higher-risk MDS.
2. ECOG score of ≤2.
3. Expected survival ≥ 3 months.
4. Adequate organ function.
5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
7. Subjects are able to complete study procedures and follow-up examinations.

Exclusion Criteria:

1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
2. Have undergone hematopoietic stem cell transplantation.
3. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
4. MDS or other conditions that cannot be administered enterally.
5. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Additional Trial Information

Phase 3

Enrollment: 490 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Not Yet Accepting

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

University of California Davis Comprehensive Cancer Center

Sacramento, CA

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Illinois

Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Chicago, IL

Open and Accepting

Indiana

Franciscan Health Cancer Center Indianapolis

Indianapolis, IN

Open and Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Not Yet Accepting

Kentucky

U of L - Brown Cancer Center University of Louisville Jewish Hospital

Louisville, KY

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

Nebraska

Nebraska Hematology Oncology

Lincoln, NE

Open and Accepting

New Jersey

John Theurer Cancer Center at Hackensack University Medical Center  Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

University of Rochester Medical Center Wilmot Cancer Center Strong Memorial Hospital

Rochester, NY

Open and Accepting

Montefiore Medical Center (Moses Campus)

The Bronx, NY

Open and Accepting

North Carolina

Durham Veterans Affairs Medical Center

Durham, NC

Open and Accepting

Novant Health Forsyth Medical Center - Silas Creek

Winston-Salem, NC

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Ohio State University Comprehensive Cancer Center James Cancer Hospital and Solove Research Institute

Columbus, OH

Open and Accepting

Pennsylvania

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

Rhode Island

Lifespan Rhode Island Hospital

Providence, RI

Not Yet Accepting

Texas

Texas Oncology - Austin Midtown

Austin, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Texas Oncology

Tyler, TX

Open and Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Open and Accepting

Washington

Swedish Cancer Institute Swedish Edmonds Campus

Edmonds, WA

Open and Accepting

Virginia Mason Medical Center Franciscan Health

Seattle, WA

Open and Accepting

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Open and Accepting
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