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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
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
Lisaftoclax (APG-2575)
QD, oral administration.
Azacitidine Injection
QD, hypodermic or intravenous injection.
Placebo
QD, oral administration.
Locations (2)
MD Anderson Cancer Center
Houston, Texas, United States
Peking University People's Hospital
Beijing, Beijing Municipality, China