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A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
Sponsor: Akeso
Summary
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-02-07
Completion Date
2026-06
Last Updated
2025-02-11
Healthy Volunteers
No
Conditions
Interventions
AK117
AK117 IV injection
Placebo
Placebo IV injection
Azacitidine
Azacitidine SC injection
Locations (15)
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
American Oncology Partners, PA (The Center for Cancer and Blood Disorders-Bethesda)
Bethesda, Maryland, United States
Maryland Oncology-Columbia
Columbia, Maryland, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
MUSC Hollings Cancer Center
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Institute of hematolongy&blood diseases hospital, chinese academy of medical sciences&peking union medical college
Tianjin, China