Spots Global Cancer Trial Database for Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
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Trial Identification
Brief Title: Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
Official Title: 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
Study ID: NCT04313881
Conditions
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Birmingham, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences IRB, Little Rock, Arkansas, United States
City of Hope, Duarte, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
UCLA Ronald Reagan Medical Center, Los Angeles, California, United States
UC Irvine Health, Orange, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
Tulane Medical Center, New Orleans, Louisiana, United States
University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute (DFCI), Boston, Massachusetts, United States
University of Michigan Medical School, Ann Arbor, Michigan, United States
University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota, United States
Mid America Division, Inc., Kansas City, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medicine-New York Presbyterian Hospital, New York, New York, United States
Mount Sinai Health System, New York, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
DUHS Duke Cancer Center, Durham, North Carolina, United States
The Ohio State University Wexner Medical Center / James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oregon Health & Science University Pharmacy Services, Portland, Oregon, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Prisma Health Cancer Center, Greenville, South Carolina, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Swedish Cancer Institute, Seattle, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Gosford Hospital, Gosford, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Icon Cancer Foundation, South Brisbane, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Center, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Eastern Health, Box Hill, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Peninsula Private Hospital, Frankston, Victoria, Australia
Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia
Cabrini Hospital Malvern, Malvern, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Uniklinikum Salzburg, Salzburg, , Austria
Hanusch kranhenkaus, 3. Medizinische Abteilung, Vienna, , Austria
ZNA Middelheim, Antwerpen, , Belgium
ULB Hopital Erasme, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
UZ Brussel, Brussels, , Belgium
UZ Leuven, Leuven, , Belgium
AZ Turnhout, Campus St. Elisabeth, Turnhout, , Belgium
Chu Ucl Namur Site Godinne, Yvoir-Godinne, , Belgium
Tom Baker Cancer Centre, Calgary, , Canada
QEII Health Sciences Centre, Halifax, , Canada
Eastern Regional Health Authority, St. John's, , Canada
University Health Network, Toronto, , Canada
Fakultni nemocnice Olomouc, Hemato-onkologicka klinika, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Klinika hemato-onkologicka, Ostrava, , Czechia
Helsinki University Central Hospital, Helsinki, , Finland
Oulu University Hospital, Oulu, , Finland
CHU Amiens-Picardie, Amiens Cedex 1, , France
Hopital Henri Mondor, Creteil, , France
CHU de Grenoble Alpes, La Tronche, , France
Institut Paoli Calmettes, Marseille, , France
Hopital Saint Eloi, Montpellier, , France
CHU de Nantes, Nantes, , France
CHU de Nice-l Archet, Nice, , France
Hopital Saint Louis, Paris, , France
Institut Gustave Roussy, Paris, , France
Hopital Haut-Leveque, Pessac Cedex, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU de Poitiers - Hopital de la Miletrie, Poitiers, , France
CHU de Rennes- Hopital Pontchaillou, Rennes Cedex 9, , France
Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik, Braunschweig, , Germany
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin, Duesseldorf, , Germany
Universitatsklinikum Essen, Essen, , Germany
Universitat Leipzig, Leipzig, , Germany
Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin, Stuttgart, , 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, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly, Gyor, , Hungary
Kaposi Mor Teaching Hospital, Kaposvar, , Hungary
Bács-Kiskun Megyei Kórház, Kecskemet, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza, , Hungary
University of Pecs, Pecs, , Hungary
Szent Borbála Hospital, Tatabanya, , Hungary
SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
U.O Ematologica- ASST degli Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico, Milan, , Italy
U.O di Ematologia, Ospedale San Gerardo- ASST Monza, Monza, , Italy
S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
SC di Oncoematologia - Azienda Ospedaliera Santa Maria, Terni, , Italy
SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
University Medical Center Groningen, Groningen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Christchurch Hospital, Christchurch, , New Zealand
Southern District Health Board, Dunedin, , New Zealand
Auckland City Hospital, Grafton, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Midcentral District Health Board, Palmerston North, , New Zealand
Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam, Bergen, , Norway
Akershus University Hospital, Loerenskog, , Norway
Oslo University Hospital, Oslo, , Norway
Stavanger universitetssjukehus, Stavanger, , Norway
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii, Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, Lublin, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw, , Poland
Centro Clinico Academico de Braga, Hospital de Braga, E.P.E, Braga, , Portugal
Champalimaud Foundation, Lisbon, , Portugal
Hospital da Luz, Lisbon, , Portugal
Centro Hospitalar Universitario Sao Joao. E.P.E, Porto, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho, Porto, , 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, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Institut Catala d'Oncologia Girona, Girona, , Spain
Institut Catala d'Oncologia, Hospital Duran i Reynals, L´Hospitalet de Llobregat, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia, Madrid, , 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, , Spain
Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia, Bellinzona, , Switzerland
University of Bern, Bern, , Switzerland
Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie, Zurich, , Switzerland
Hematoloji Bilim Dali, Yenimahalle, Ankara, , Turkey
Gazi Universitesi Tip Fakultesi, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi, Ankara, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu, Inciralt, , Turkey
Mersin University Medical, Mersin, , Turkey
Tekirdag Namik Kemal Universitesi Tip Fakultesi, Tekirdag, , Turkey
University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom
United Lincolnshire Hospital NHS Trust, Boston, , United Kingdom
Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust, Canterbury, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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