Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
NCT ID: NCT04313881
Last Updated: 2024-06-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
539 participants
INTERVENTIONAL
2020-09-09
2023-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Magrolimab + Azacitidine
Participants will receive the following magrolimab and azacitidine dosing regimens:
Magrolimab:
Magrolimab Priming Dose:
* 1 mg/kg on Days 1 and 4
* 15 mg/kg on Day 8
* 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50)
Magrolimab Maintenance Dose:
* 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter.
Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.
Magrolimab
Administered intravenously
Azacitidine
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Control Arm (Placebo + Azacitidine)
Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine:
Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter.
Azacitidine: 75 mg/m\^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.
Azacitidine
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Placebo
Placebo to match magrolimab administered intravenously
Interventions
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Magrolimab
Administered intravenously
Azacitidine
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Placebo
Placebo to match magrolimab administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate performance status and hematological, liver, and kidney function.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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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
St 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
Antwerp, , Belgium
ULB Hopital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Chu Ucl Namur Site Godinne
Godinne, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Turnhout, Campus St. Elisabeth
Turnhout, , 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, , France
Hopital Henri Mondor
Créteil, , 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, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers - Hopital de la Miletrie
Poitiers, , France
CHU de Rennes- Hopital Pontchaillou
Rennes, , 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
Düsseldorf, , 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
Győr, , Hungary
Kaposi Mor Teaching Hospital
Kaposvár, , Hungary
Bács-Kiskun Megyei Kórház
Kecskemét, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
University of Pecs
Pécs, , Hungary
Szent Borbála Hospital
Tatabánya, , 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
Florence, , 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
Málaga, , 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
Seville, , 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 (Türkiye)
Gazi Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu
Inciralt, , Turkey (Türkiye)
Mersin University Medical
Mersin, , Turkey (Türkiye)
Tekirdag Namik Kemal Universitesi Tip Fakultesi
Tekirdağ, , Turkey (Türkiye)
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
Countries
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References
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Sallman DA, Al Malki MM, Asch AS, Wang ES, Jurcic JG, Bradley TJ, Flinn IW, Pollyea DA, Kambhampati S, Tanaka TN, Zeidner JF, Garcia-Manero G, Jeyakumar D, Komrokji R, Lancet J, Kantarjian HM, Gu L, Zhang Y, Tan A, Chao M, O'Hear C, Ramsingh G, Lal I, Vyas P, Daver NG. Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study. J Clin Oncol. 2023 May 20;41(15):2815-2826. doi: 10.1200/JCO.22.01794. Epub 2023 Mar 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: First Interim Analyses
Document Type: Statistical Analysis Plan: Second Interim and Final Analyses
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-004287-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5F9009
Identifier Type: -
Identifier Source: org_study_id
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