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

PHASE3TerminatedINTERVENTIONAL
Enrollment

539

Participants

Timeline

Start Date

September 9, 2020

Primary Completion Date

September 13, 2023

Study Completion Date

September 13, 2023

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Magrolimab

Administered intravenously

DRUG

Azacitidine

Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling

DRUG

Placebo

Placebo to match magrolimab administered intravenously

Trial Locations (169)

1070

ULB Hopital Erasme, Brussels

1125

Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika, Budapest

1140

Hanusch kranhenkaus, 3. Medizinische Abteilung, Vienna

1142

Auckland City Hospital, Grafton

1200

Cliniques Universitaires Saint-Luc, Brussels

1478

Akershus University Hospital, Loerenskog

2031

Prince of Wales Hospital, Randwick

2060

ZNA Middelheim, Antwerp

2065

Royal North Shore Hospital, St Leonards

2145

Westmead Hospital, Westmead

2250

Gosford Hospital, Gosford

2300

AZ Turnhout, Campus St. Elisabeth, Turnhout

2800

Szent Borbála Hospital, Tatabánya

3000

UZ Leuven, Leuven

3004

The Alfred Hospital, Melbourne

3010

University of Bern, Bern

3050

Royal Melbourne Hospital, Parkville

3128

Eastern Health, Box Hill

3144

Cabrini Hospital Malvern, Malvern

3168

Monash Medical Centre, Clayton

3199

Peninsula Private Hospital, Frankston

3220

Barwon Health, University Hospital Geelong, Geelong

3240

Waikato Hospital, Hamilton

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4068

Stavanger universitetssjukehus, Stavanger

4101

Icon Cancer Foundation, South Brisbane

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4414

Midcentral District Health Board, Palmerston North

4710

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

5000

Royal Adelaide Hospital, Adelaide

5020

Uniklinikum Salzburg, Salzburg

5021

Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam, Bergen

5042

Flinders Medical Center, Bedford Park

5530

Chu Ucl Namur Site Godinne, Godinne

6000

Bács-Kiskun Megyei Kórház, Kecskemét

6009

Sir Charles Gairdner Hospital, Nedlands

6200

CHU de Nice-l Archet, Nice

6500

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

7000

Royal Hobart Hospital, Hobart

7624

University of Pecs, Pécs

8011

Christchurch Hospital, Christchurch

8091

Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie, Zurich

9016

Southern District Health Board, Dunedin

9024

Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly, Győr

10021

Weill Cornell Medicine-New York Presbyterian Hospital, New York

10029

Mount Sinai Health System, New York

10032

Columbia University Medical Center - Herbert Irving Pavilion, New York

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

15100

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

17007

Institut Catala d'Oncologia Girona, Girona

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

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

19111

Fox Chase Cancer Center, Philadelphia

20052

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

20090

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin

20122

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

21100

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

21201

University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore

21231

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore

27599

University of North Carolina at Chapel Hill, Chapel Hill

27705

DUHS Duke Cancer Center, Durham

28033

MD Anderson Cancer Center Madrid, Madrid

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

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

28100

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

29615

Prisma Health Cancer Center, Greenville

30322

Winship Cancer Institute, Atlanta

31008

Centro Hospitalar Universitario Sao Joao, Pamplona

33110

Mersin University Medical, Mersin

33136

University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center, Miami

33604

Hopital Haut-Leveque, Pessac

33612

Moffitt Cancer Center, Tampa

34295

Hopital Saint Eloi, Montpellier

35033

CHU de Rennes- Hopital Pontchaillou, Rennes

35294

University of Alabama Birmingham, Birmingham

35340

Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu, Inciralt

37203

Tennessee Oncology, PLLC, Nashville

38114

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

38700

CHU de Grenoble Alpes, La Tronche

39090

UT Southwestern Medical Center, Dallas

41013

Hospital Universitario Virgen del Rocio, Seville

43210

The Ohio State University Wexner Medical Center / James Cancer Hospital, Columbus

44000

CHU de Nantes, Nantes

45122

Universitatsklinikum Essen, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

48109

University of Michigan Medical School, Ann Arbor

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

53226

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

55455

University of Minnesota Medical Center, Fairview, Minneapolis

59100

Tekirdag Namik Kemal Universitesi Tip Fakultesi, Tekirdağ

60611

Northwestern Memorial Hospital, Chicago

60637

The University of Chicago Medical Center, Chicago

61100

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro

63110

Washington University School of Medicine - Siteman Cancer Center, St Louis

64132

Mid America Division, Inc., Kansas City

66205

University of Kansas Clinical Research Center, Fairway

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

Tulane Medical Center, New Orleans

70376

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

70852

Fakultni nemocnice Ostrava, Klinika hemato-onkologicka, Ostrava

72205

University of Arkansas for Medical Sciences IRB, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75246

Texas Oncology - Baylor Charles A. Simmons Cancer Center, Dallas

75475

Hopital Saint Louis, Paris

77030

Baylor College of Medicine, Houston

The University of Texas MD Anderson Cancer Center, Houston

77520

Fakultni nemocnice Olomouc, Hemato-onkologicka klinika, Olomouc

80054

CHU Amiens-Picardie, Amiens

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

86000

CHU de Poitiers - Hopital de la Miletrie, Poitiers

90095

UCLA Ronald Reagan Medical Center, Los Angeles

90220

Oulu University Hospital, Oulu

91010

City of Hope, Duarte

92093

UC San Diego Moores Cancer Center, La Jolla

92868

UC Irvine Health, Orange

94010

Hopital Henri Mondor, Créteil

94305

Stanford Cancer Institute, Palo Alto

94805

Institut Gustave Roussy, Paris

95817

University of California, Davis Comprehensive Cancer Center, Sacramento

97239

Oregon Health & Science University Pharmacy Services, Portland

98019

Seattle Cancer Care Alliance, Seattle

98104

Swedish Cancer Institute, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute (DFCI), Boston

Unknown

UZ Brussel, Brussels

Institut Paoli Calmettes, Marseille

Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin, Düsseldorf

Universitat Leipzig, Leipzig

Hong Kong Sanatorium & Hospital, Hong Kong

Princess Margaret Hospital, Hong Kong

Queen Mary Hospital, Hong Kong

The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

Kaposi Mor Teaching Hospital, Kaposvár

U.O Ematologica- ASST degli Spedali Civili di Brescia, Brescia

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

OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu, Alava

Institut Catala d'Oncologia, Hospital Duran i Reynals, L'Hospitalet de Llobregat

Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia, Madrid

Hospital Regional Universitario de Malaga, Málaga

Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca, Salamanca

T2N 4N2

Tom Baker Cancer Centre, Calgary

B3H 2Y9

QEII Health Sciences Centre, Halifax

A1B 3V6

Eastern Regional Health Authority, St. John's

M5G 2M9

University Health Network, Toronto

00290

Helsinki University Central Hospital, Helsinki

01307

Universitatsklinikum Carl Gustav Carus, Dresden

05100

SC di Oncoematologia - Azienda Ospedaliera Santa Maria, Terni

9700 RB

University Medical Center Groningen, Groningen

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

0372

Oslo University Hospital, Oslo

31-501

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

50-367

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw

1400 - 038

Champalimaud Foundation, Lisbon

1500-650

Hospital da Luz, Lisbon

4200 319

Centro Hospitalar Universitario Sao Joao. E.P.E, Porto

4200-072

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto

4430-999

Centro Hospitalar Vila Nova de Gaia/Espinho, Porto

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall D'Hebron, Barcelona

06200

Hematoloji Bilim Dali, Yenimahalle, Ankara

06560

Gazi Universitesi Tip Fakultesi, Ankara

06620

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

PE21 9QS

United Lincolnshire Hospital NHS Trust, Boston

CT1 3NG

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

OX3 9DU

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter