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Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

Trial Status: Active

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate / high / very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Inclusion Criteria

  • Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
  • Adequate performance status and hematological, liver, and kidney function

Exclusion Criteria

  • Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor
  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents
  • Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year
  • Contraindications to azacitidine
  • Clinical suspicion of active central nervous system (CNS) involvement by MDS
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history
  • Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening
  • Pregnancy or active breastfeeding

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Pankit Vachhani
Phone: 347-863-7340

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Bruck Habtemariam
Phone: 310-794-0242
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
San Diego
UC San Diego Medical Center - Hillcrest
Status: CLOSED_TO_ACCRUAL

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
Northwestern University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
University of Maryland / Greenebaum Cancer Center
Status: ACTIVE
Contact: Sunita Philip
Phone: 410-328-8199

Massachusetts

Boston
Brigham and Women's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Eytan M. Stein
Phone: 212-639-3314
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Thomas Jefferson University Hospital
Status: ACTIVE
University of Pennsylvania / Abramson Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: APPROVED
M D Anderson Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Gilead

  • Primary ID 5F9009
  • Secondary IDs NCI-2020-03406, 2020-004287-26
  • Clinicaltrials.gov ID NCT04313881