Myelodysplastic Syndrome Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

Key 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.

Key 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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

539

Study ID:

NCT04313881

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 149 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
University of Arkansas for Medical Sciences IRB
Little Rock Arkansas, 72205, United States
City of Hope
Duarte California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
UCLA Ronald Reagan Medical Center
Los Angeles California, 90095, United States
UC Irvine Health
Orange California, 92868, United States
Stanford Cancer Institute
Palo Alto California, 94305, United States
University of California, Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
Tulane Medical Center
New Orleans Louisiana, 70112, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute (DFCI)
Boston Massachusetts, 02215, United States
University of Michigan Medical School
Ann Arbor Michigan, 48109, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
Mid America Division, Inc.
Kansas City Missouri, 64132, United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York New York, 10021, United States
Mount Sinai Health System
New York New York, 10029, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
DUHS Duke Cancer Center
Durham North Carolina, 27705, United States
The Ohio State University Wexner Medical Center / James Cancer Hospital
Columbus Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oregon Health & Science University Pharmacy Services
Portland Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Prisma Health Cancer Center
Greenville South Carolina, 29615, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
UT Southwestern Medical Center
Dallas Texas, 39090, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center
Dallas Texas, 75246, United States
Baylor College of Medicine
Houston Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle Washington, 98019, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Gosford Hospital
Gosford New South Wales, 2250, Australia
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Icon Cancer Foundation
South Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Flinders Medical Center
Bedford Park South Australia, 5042, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Eastern Health
Box Hill Victoria, 3128, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Peninsula Private Hospital
Frankston Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong Victoria, 3220, Australia
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Uniklinikum Salzburg
Salzburg , 5020, Austria
Hanusch kranhenkaus, 3. Medizinische Abteilung
Vienna , 1140, Austria
ZNA Middelheim
Antwerpen , 2060, Belgium
ULB Hopital Erasme
Brussels , 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
UZ Brussel
Brussels , , Belgium
UZ Leuven
Leuven , 3000, Belgium
AZ Turnhout, Campus St. Elisabeth
Turnhout , 2300, Belgium
Chu Ucl Namur Site Godinne
Yvoir-Godinne , 5530, Belgium
Tom Baker Cancer Centre
Calgary , T2N 4, Canada
QEII Health Sciences Centre
Halifax , B3H 2, Canada
Eastern Regional Health Authority
St. John's , A1B 3, Canada
University Health Network
Toronto , M5G 2, Canada
Fakultni nemocnice Olomouc, Hemato-onkologicka klinika
Olomouc , 77520, Czechia
Fakultni nemocnice Ostrava, Klinika hemato-onkologicka
Ostrava , 70852, Czechia
Helsinki University Central Hospital
Helsinki , 00290, Finland
Oulu University Hospital
Oulu , 90220, Finland
CHU Amiens-Picardie
Amiens Cedex 1 , 80054, France
Hopital Henri Mondor
Creteil , 94010, France
CHU de Grenoble Alpes
La Tronche , 38700, France
Institut Paoli Calmettes
Marseille , , France
Hopital Saint Eloi
Montpellier , 34295, France
CHU de Nantes
Nantes , 44000, France
CHU de Nice-l Archet
Nice , 6200, France
Hopital Saint Louis
Paris , 75475, France
Institut Gustave Roussy
Paris , 94805, France
Hopital Haut-Leveque
Pessac Cedex , 33604, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
CHU de Poitiers - Hopital de la Miletrie
Poitiers , 86000, France
CHU de Rennes- Hopital Pontchaillou
Rennes Cedex 9 , 35033, France
Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik
Braunschweig , 38114, Germany
Universitatsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin
Duesseldorf , , Germany
Universitatsklinikum Essen
Essen , 45122, Germany
Universitat Leipzig
Leipzig , , Germany
Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin
Stuttgart , 70376, Germany
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 , 1125, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen , 4032, Hungary
Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly
Gyor , 9024, Hungary
Kaposi Mor Teaching Hospital
Kaposvar , , Hungary
Bács-Kiskun Megyei Kórház
Kecskemet , 6000, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
University of Pecs
Pecs , 7624, Hungary
Szent Borbála Hospital
Tatabanya , 2800, Hungary
SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
Alessandria , 15100, Italy
U.O Ematologica- ASST degli Spedali Civili di Brescia
Brescia , , Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze , 50134, Italy
U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan , 20122, Italy
U.O di Ematologia, Ospedale San Gerardo- ASST Monza
Monza , 20052, Italy
S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita
Novara , 28100, Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro , 61100, Italy
SC di Oncoematologia - Azienda Ospedaliera Santa Maria
Terni , 05100, Italy
SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Varese , 21100, Italy
University Medical Center Groningen
Groningen , 9700 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , 8934 , Netherlands
Christchurch Hospital
Christchurch , 8011, New Zealand
Southern District Health Board
Dunedin , 9016, New Zealand
Auckland City Hospital
Grafton , 1142, New Zealand
Waikato Hospital
Hamilton , 3240, New Zealand
Midcentral District Health Board
Palmerston North , 4414, New Zealand
Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam
Bergen , 5021, Norway
Akershus University Hospital
Loerenskog , 1478, Norway
Oslo University Hospital
Oslo , 0372, Norway
Stavanger universitetssjukehus
Stavanger , 4068, Norway
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
Krakow , 31-50, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20090, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
Centro Clinico Academico de Braga, Hospital de Braga, E.P.E
Braga , 4710, Portugal
Champalimaud Foundation
Lisbon , 1400 , Portugal
Hospital da Luz
Lisbon , 1500-, Portugal
Centro Hospitalar Universitario Sao Joao. E.P.E
Porto , 4200 , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto , 4200-, Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho
Porto , 4430-, Portugal
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 , 08003, Spain
Hospital Universitari Vall D'Hebron
Barcelona , 08035, Spain
Institut Catala d'Oncologia Girona
Girona , 17007, Spain
Institut Catala d'Oncologia, Hospital Duran i Reynals
L´Hospitalet de Llobregat , , Spain
MD Anderson Cancer Center Madrid
Madrid , 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia
Madrid , 28046, Spain
Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia
Madrid , , Spain
Hospital Regional Universitario de Malaga
Malaga , , Spain
Centro Hospitalar Universitario Sao Joao
Pamplona , 31008, Spain
Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca
Salamanca , , Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia
Bellinzona , 6500, Switzerland
University of Bern
Bern , 3010, Switzerland
Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
Zurich , 8091, Switzerland
Hematoloji Bilim Dali, Yenimahalle
Ankara , 06200, Turkey
Gazi Universitesi Tip Fakultesi
Ankara , 06560, Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara , 06620, Turkey
Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu
Inciralt , 35340, Turkey
Mersin University Medical
Mersin , 33110, Turkey
Tekirdag Namik Kemal Universitesi Tip Fakultesi
Tekirdag , 59100, Turkey
University Hospitals Birmingham NHS Foundation Trust
Birmingham , B15 2, United Kingdom
United Lincolnshire Hospital NHS Trust
Boston , PE21 , United Kingdom
Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust
Canterbury , CT1 3, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , OX3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

539

Study ID:

NCT04313881

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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