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).
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 149 Locations for this study
Birmingham Alabama, 35294, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94305, United States
Sacramento California, 95817, United States
Miami Florida, 33136, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Fairway Kansas, 66205, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Minneapolis Minnesota, 55455, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73104, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Greenville South Carolina, 29615, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 39090, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98019, United States
Seattle Washington, 98104, United States
Milwaukee Wisconsin, 53226, United States
Gosford New South Wales, 2250, Australia
Randwick New South Wales, 2031, Australia
St Leonards New South Wales, 2065, Australia
Westmead New South Wales, 2145, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5000, Australia
Bedford Park South Australia, 5042, Australia
Hobart Tasmania, 7000, Australia
Box Hill Victoria, 3128, Australia
Clayton Victoria, 3168, Australia
Frankston Victoria, 3199, Australia
Geelong Victoria, 3220, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3004, Australia
Parkville Victoria, 3050, Australia
Nedlands Western Australia, 6009, Australia
Salzburg , 5020, Austria
Vienna , 1140, Austria
Antwerpen , 2060, Belgium
Brussels , 1070, Belgium
Brussels , 1200, Belgium
Brussels , , Belgium
Leuven , 3000, Belgium
Turnhout , 2300, Belgium
Yvoir-Godinne , 5530, Belgium
Calgary , T2N 4, Canada
Halifax , B3H 2, Canada
St. John's , A1B 3, Canada
Toronto , M5G 2, Canada
Olomouc , 77520, Czechia
Ostrava , 70852, Czechia
Helsinki , 00290, Finland
Oulu , 90220, Finland
Amiens Cedex 1 , 80054, France
Creteil , 94010, France
La Tronche , 38700, France
Marseille , , France
Montpellier , 34295, France
Nantes , 44000, France
Nice , 6200, France
Paris , 75475, France
Paris , 94805, France
Pessac Cedex , 33604, France
Pierre Benite , 69495, France
Poitiers , 86000, France
Rennes Cedex 9 , 35033, France
Braunschweig , 38114, Germany
Dresden , 01307, Germany
Duesseldorf , , Germany
Essen , 45122, Germany
Leipzig , , Germany
Stuttgart , 70376, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Budapest , 1125, Hungary
Debrecen , 4032, Hungary
Gyor , 9024, Hungary
Kaposvar , , Hungary
Kecskemet , 6000, Hungary
Nyiregyhaza , 4400, Hungary
Pecs , 7624, Hungary
Tatabanya , 2800, Hungary
Alessandria , 15100, Italy
Brescia , , Italy
Firenze , 50134, Italy
Milan , 20122, Italy
Monza , 20052, Italy
Novara , 28100, Italy
Pesaro , 61100, Italy
Terni , 05100, Italy
Varese , 21100, Italy
Groningen , 9700 , Netherlands
Leeuwarden , 8934 , Netherlands
Christchurch , 8011, New Zealand
Dunedin , 9016, New Zealand
Grafton , 1142, New Zealand
Hamilton , 3240, New Zealand
Palmerston North , 4414, New Zealand
Bergen , 5021, Norway
Loerenskog , 1478, Norway
Oslo , 0372, Norway
Stavanger , 4068, Norway
Krakow , 31-50, Poland
Lublin , 20090, Poland
Wroclaw , 50-36, Poland
Braga , 4710, Portugal
Lisbon , 1400 , Portugal
Lisbon , 1500-, Portugal
Porto , 4200 , Portugal
Porto , 4200-, Portugal
Porto , 4430-, Portugal
A Coruña , , Spain
Alava , , Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Girona , 17007, Spain
L´Hospitalet de Llobregat , , Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Madrid , , Spain
Malaga , , Spain
Pamplona , 31008, Spain
Salamanca , , Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Bellinzona , 6500, Switzerland
Bern , 3010, Switzerland
Zurich , 8091, Switzerland
Ankara , 06200, Turkey
Ankara , 06560, Turkey
Ankara , 06620, Turkey
Inciralt , 35340, Turkey
Mersin , 33110, Turkey
Tekirdag , 59100, Turkey
Birmingham , B15 2, United Kingdom
Boston , PE21 , United Kingdom
Canterbury , CT1 3, United Kingdom
Oxford , OX3 9, United Kingdom
How clear is this clinincal trial information?