STATUS Terminated

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Terminated

GILEAD STUDY ID

5F9009

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

June 27, 2024

Clinicaltrials.gov ID

NCT04313881

EudraCT ID

2020-004287-26

STUDY DOCUMENTS

View study documents

OVERVIEW

ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome (ENHANCE)

PROTOCOL SUMMARY

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).

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Myelodysplastic Syndromes

Gender

N/A

Date

September 2020 - September 2023

Study Type

Interventional

Study Phase

Phase 3

Product

Magrolimab, Azacitidine, Placebo

Eligibility information

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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (169)

University of Alabama Birmingham

Birmingham, Alabama, United States, 35294

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (169)

University of Alabama Birmingham

University of Arkansas for Medical Sciences IRB

City of Hope

UC San Diego Moores Cancer Center

UCLA Ronald Reagan Medical Center

UC Irvine Health

Stanford Cancer Institute

University of California, Davis Comprehensive Cancer Center

University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

Moffitt Cancer Center

Winship Cancer Institute

Northwestern Memorial Hospital

The University of Chicago Medical Center

University of Kansas Clinical Research Center

Tulane Medical Center

University of Maryland, Greenebaum Comprehensive Cancer Center

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Dana Farber Cancer Institute (DFCI)

University of Michigan Medical School

University of Minnesota Medical Center, Fairview

Mid America Division, Inc.

Washington University School of Medicine - Siteman Cancer Center

Roswell Park Cancer Institute

Weill Cornell Medicine-New York Presbyterian Hospital

Mount Sinai Health System

Columbia University Medical Center - Herbert Irving Pavilion

Memorial Sloan Kettering Cancer Center

University of North Carolina at Chapel Hill

DUHS Duke Cancer Center

The Ohio State University Wexner Medical Center / James Cancer Hospital

University of Oklahoma Health Sciences Center

Oregon Health & Science University Pharmacy Services

Hospital of the University of Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization

Fox Chase Cancer Center

Prisma Health Cancer Center

Tennessee Oncology, PLLC

UT Southwestern Medical Center

Texas Oncology - Baylor Charles A. Simmons Cancer Center

Baylor College of Medicine

The University of Texas MD Anderson Cancer Center

Huntsman Cancer Institute/University of Utah

Seattle Cancer Care Alliance

Swedish Cancer Institute

Froedtert Hospital & the Medical College of Wisconsin

Gosford Hospital

Prince of Wales Hospital

Royal North Shore Hospital

Westmead Hospital

Icon Cancer Foundation

Royal Adelaide Hospital

Flinders Medical Center

Royal Hobart Hospital

Eastern Health

Monash Medical Centre

Peninsula Private Hospital

Barwon Health, University Hospital Geelong

Cabrini Hospital Malvern

The Alfred Hospital

Royal Melbourne Hospital

Sir Charles Gairdner Hospital

Uniklinikum Salzburg

Hanusch kranhenkaus, 3. Medizinische Abteilung

ZNA Middelheim

ULB Hopital Erasme

Cliniques Universitaires Saint-Luc