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Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
Sponsor: Ascentage Pharma Group Inc.
Summary
A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.
Official title: A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
490
Start Date
2025-01-22
Completion Date
2029-12
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
Lisaftoclax (APG-2575)
QD, oral administration.
Azacitidine Injection
QD, hypodermic or intravenous injection.
Placebo
QD, oral administration.
Locations (155)
Ascentage Investigative Site
Birmingham, Alabama, United States
Ascentage Investigative Site
Phoenix, Arizona, United States
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Los Angeles, California, United States
Ascentage Investigative Site
Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
Ascentage
Iowa City, Iowa, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Hackensack, New Jersey, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Eugene, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Tyler, Texas, United States
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Charlottesville, Virginia, United States
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Manassas, Virginia, United States
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Norfolk, Virginia, United States
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Edmonds, Washington, United States
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Issaquah, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Waukesha, Wisconsin, United States
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Blacktown, Australia, Australia
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Cooloongup, Australia, Australia
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Epping, Australia, Australia
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Heidelberg, Australia, Australia
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Kingswood, Australia, Australia
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Liverpool, Australia, Australia
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Melbourne, Australia, Australia
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Perth, Australia, Australia
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Richmond, Australia, Australia
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Waratah, Australia, Australia
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Antwerp, Belgium
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Brasschaat, Belgium
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Bruges, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Roeselare, Belgium
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, Beijing Municipality, China
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Brno, Czechia
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Hradec Králové, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Helsinki, Finland, Finland
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Kuopio, Finland, Finland
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Tampere, Finland, Finland
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Angers, France, France
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Le Mans, France, France
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Limoges, France, France
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Nantes, France, France
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Nantes, France, France
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Nice, France, France
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Orléans, France, France
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Paris, France, France
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Pessac, France, France
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Poitiers, France, France
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Pontoise, France, France
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Tours, France, France
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Villejuif, France, France
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Berlin, Germany, Germany
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Dresden, Germany, Germany
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Dresden, Germany, Germany
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Düsseldorf, Germany, Germany
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Halle, Germany, Germany
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Leipzig, Germany, Germany
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Stuttgart, Germany, Germany
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Ulm, Germany, Germany
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Alexandroupoli, Greece, Greece
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Athens, Greece, Greece
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Athens, Greece, Greece
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Athens, Greece, Greece
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Athens, Greece, Greece
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Pátrai, Greece, Greece
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Thessaloniki, Greece, Greece
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Budapest, Hungary, Hungary
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Budapest, Hungary, Hungary
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Debrecen, Hungary, Hungary
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Kaposvár, Hungary, Hungary
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Candiolo, Italy, Italy
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Ferrara, Italy, Italy
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Florence, Italy, Italy
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Meldola, Italy, Italy
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Milan, Italy, Italy
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Novara, Italy, Italy
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Ravenna, Italy, Italy
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Roma, Italy, Italy
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Roma, Italy, Italy
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Roma, Italy, Italy
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Rozzano, Italy, Italy
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Torino, Italy, Italy
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Varese, Italy, Italy
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Bergen, Norway, Norway
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Oslo, Norway, Norway
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Skien, Norway, Norway
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Gdansk, Poland, Poland
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Lodz, Poland, Poland
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Olsztyn, Poland, Poland
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Warsaw, Poland, Poland
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Badalona, Spain, Spain
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Barcelona, Spain, Spain
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Barcelona, Spain, Spain
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Cáceres, Spain, Spain
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Girona, Spain, Spain
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Madrid, Spain, Spain
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Madrid, Spain, Spain
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Madrid, Spain, Spain
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Madrid, Spain, Spain
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Madrid, Spain, Spain
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Málaga, Spain, Spain
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Ourense, Spain, Spain
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Oviedo, Spain, Spain
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Pamplona, Spain, Spain
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Seville, Spain, Spain
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Valencia, Spain, Spain
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Valencia, Spain, Spain
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Örebro, Sweden, Sweden
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Boston, UK, United Kingdom
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Aberdeen, United Kingdom
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Birmingham, United Kingdom
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Boston, United Kingdom
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Cardiff, United Kingdom
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Coventry, United Kingdom
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Dorchester, United Kingdom
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Exeter, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
Ascentage Investigative Site
Manchester, United Kingdom