Study Details

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

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

University of Arkansas for Medical Sciences IRB

Little Rock, Arkansas, United States, 72205

City of Hope

Duarte, California, United States, 91010

UC San Diego Moores Cancer Center

La Jolla, California, United States, 92093

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States, 90095

UC Irvine Health

Orange, California, United States, 92868

Stanford Cancer Institute

Palo Alto, California, United States, 94305

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

Miami, Florida, United States, 33136

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

The University of Chicago Medical Center

Chicago, Illinois, United States, 60637

University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

Tulane Medical Center

New Orleans, Louisiana, United States, 70112

University of Maryland, Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21231

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States, 02215

University of Michigan Medical School

Ann Arbor, Michigan, United States, 48109

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States, 55455

Mid America Division, Inc.

Kansas City, Missouri, United States, 64132

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, United States, 10021

Mount Sinai Health System

New York, New York, United States, 10029

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

DUHS Duke Cancer Center

Durham, North Carolina, United States, 27705

The Ohio State University Wexner Medical Center / James Cancer Hospital

Columbus, Ohio, United States, 43210

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Oregon Health & Science University Pharmacy Services

Portland, Oregon, United States, 97239

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

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

Philadelphia, Pennsylvania, United States, 19107

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Prisma Health Cancer Center

Greenville, South Carolina, United States, 29615

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

UT Southwestern Medical Center

Dallas, Texas, United States, 39090

Texas Oncology - Baylor Charles A. Simmons Cancer Center

Dallas, Texas, United States, 75246

Baylor College of Medicine

Houston, Texas, United States, 77030

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

Seattle Cancer Care Alliance

Seattle, Washington, United States, 98019

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Gosford Hospital

Gosford, New South Wales, Australia, 2250

Prince of Wales Hospital

Randwick, New South Wales, Australia, 2031

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Icon Cancer Foundation

South Brisbane, Queensland, Australia, 4101

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Flinders Medical Center

Bedford Park, South Australia, Australia, 5042

Royal Hobart Hospital

Hobart, Tasmania, Australia, 7000

Eastern Health

Box Hill, Victoria, Australia, 3128

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Peninsula Private Hospital

Frankston, Victoria, Australia, 3199

Barwon Health, University Hospital Geelong

Geelong, Victoria, Australia, 3220

Cabrini Hospital Malvern

Malvern, Victoria, Australia, 3144

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Uniklinikum Salzburg

Salzburg, Austria, 5020

Hanusch kranhenkaus, 3. Medizinische Abteilung

Vienna, Austria, 1140

ZNA Middelheim

Antwerpen, Belgium, 2060

ULB Hopital Erasme

Brussels, Belgium, 1070

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

UZ Brussel

Brussels, Belgium

UZ Leuven

Leuven, Belgium, 3000

AZ Turnhout, Campus St. Elisabeth

Turnhout, Belgium, 2300

Chu Ucl Namur Site Godinne

Yvoir-Godinne, Belgium, 5530

Tom Baker Cancer Centre

Calgary, Canada, T2N 4N2

QEII Health Sciences Centre

Halifax, Canada, B3H 2Y9

Eastern Regional Health Authority

St. John's, Canada, A1B 3V6

University Health Network

Toronto, Canada, M5G 2M9

Fakultni nemocnice Olomouc, Hemato-onkologicka klinika

Olomouc, Czechia, 77520

Fakultni nemocnice Ostrava, Klinika hemato-onkologicka

Ostrava, Czechia, 70852

Helsinki University Central Hospital

Helsinki, Finland, 00290

Oulu University Hospital

Oulu, Finland, 90220

CHU Amiens-Picardie

Amiens Cedex 1, France, 80054

Hopital Henri Mondor

Creteil, France, 94010

CHU de Grenoble Alpes

La Tronche, France, 38700

Institut Paoli Calmettes

Marseille, France

Hopital Saint Eloi

Montpellier, France, 34295

CHU de Nantes

Nantes, France, 44000

CHU de Nice-l Archet

Nice, France, 6200

Hopital Saint Louis

Paris, France, 75475

Institut Gustave Roussy

Paris, France, 94805

Hopital Haut-Leveque

Pessac Cedex, France, 33604

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

CHU de Poitiers - Hopital de la Miletrie

Poitiers, France, 86000

CHU de Rennes- Hopital Pontchaillou

Rennes Cedex 9, France, 35033

Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik

Braunschweig, Germany, 38114

Universitatsklinikum Carl Gustav Carus

Dresden, Germany, 01307

Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin

Duesseldorf, Germany

Universitatsklinikum Essen

Essen, Germany, 45122

Universitat Leipzig

Leipzig, Germany

Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin

Stuttgart, Germany, 70376

Hong Kong Sanatorium & Hospital

Hong Kong, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika

Budapest, Hungary, 1125

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary, 4032

Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly

Gyor, Hungary, 9024

Kaposi Mor Teaching Hospital

Kaposvar, Hungary

Bács-Kiskun Megyei Kórház

Kecskemet, Hungary, 6000

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyiregyhaza, Hungary, 4400

University of Pecs

Pecs, Hungary, 7624

Szent Borbála Hospital

Tatabanya, Hungary, 2800

SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

Alessandria, Italy, 15100

U.O Ematologica- ASST degli Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliero-Universitaria Careggi

Firenze, Italy, 50134

U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

U.O di Ematologia, Ospedale San Gerardo- ASST Monza

Monza, Italy, 20052

S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita

Novara, Italy, 28100

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Italy, 61100

SC di Oncoematologia - Azienda Ospedaliera Santa Maria

Terni, Italy, 05100

SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi

Varese, Italy, 21100

University Medical Center Groningen

Groningen, Netherlands, 9700 RB

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands, 8934 AD

Christchurch Hospital

Christchurch, New Zealand, 8011

Southern District Health Board

Dunedin, New Zealand, 9016

Auckland City Hospital

Grafton, New Zealand, 1142

Waikato Hospital

Hamilton, New Zealand, 3240

Midcentral District Health Board

Palmerston North, New Zealand, 4414

Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam

Bergen, Norway, 5021

Akershus University Hospital

Loerenskog, Norway, 1478

Oslo University Hospital

Oslo, Norway, 0372

Stavanger universitetssjukehus

Stavanger, Norway, 4068

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

Krakow, Poland, 31-501

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, Poland, 20090

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, Poland, 50-367

Centro Clinico Academico de Braga, Hospital de Braga, E.P.E

Braga, Portugal, 4710

Champalimaud Foundation

Lisbon, Portugal, 1400 - 038

Hospital da Luz

Lisbon, Portugal, 1500-650

Centro Hospitalar Universitario Sao Joao. E.P.E

Porto, Portugal, 4200 319

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal, 4200-072

Centro Hospitalar Vila Nova de Gaia/Espinho

Porto, Portugal, 4430-999

Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD

A Coruña, Spain

OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu

Alava, Spain

Hospital del Mar

Barcelona, Spain, 08003

Hospital Universitari Vall D'Hebron

Barcelona, Spain, 08035

Institut Catala d'Oncologia Girona

Girona, Spain, 17007

Institut Catala d'Oncologia, Hospital Duran i Reynals

L´Hospitalet de Llobregat, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain, 28033

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28040

Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia

Madrid, Spain, 28046

Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia

Madrid, Spain

Hospital Regional Universitario de Malaga

Malaga, Spain

Centro Hospitalar Universitario Sao Joao

Pamplona, Spain, 31008

Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia

Bellinzona, Switzerland, 6500

University of Bern

Bern, Switzerland, 3010

Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

Zurich, Switzerland, 8091

Hematoloji Bilim Dali, Yenimahalle

Ankara, Turkey, 06200

Gazi Universitesi Tip Fakultesi

Ankara, Turkey, 06560

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, Turkey, 06620

Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu

Inciralt, Turkey, 35340

Mersin University Medical

Mersin, Turkey, 33110

Tekirdag Namik Kemal Universitesi Tip Fakultesi

Tekirdag, Turkey, 59100

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2TH

United Lincolnshire Hospital NHS Trust

Boston, United Kingdom, PE21 9QS

Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom, CT1 3NG

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 9DU

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

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

UZ Brussel

UZ Leuven