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A global, multicenter, double-blind, randomized, Phase 3 registration study of Lisaftoclax (APG-2575) in combination with azacitidine (AZA) in patients with newly diagnosed higher-risk myelodysplastic syndrome
THIS STUDY IS DESIGNED TO EVALUATE THE DIFFERENCE IN EFFICACY AND SAFETY OF LISAFTOCLAX, ALSO KNOWN AS APG-2575, IN COMBINATION WITH AZACITIDINE (AZA), COMPARED TO A PLACEBO EQUIVALENT OF APG-2575 IN COMBINATION WITH AZA. THE PLACEBO IS A TREATMENT WITH NO ACTIVE INGREDIENTS. APG-2575 IN COMBINATION WITH AZA OR PLACEBO EQUIVALENT OF APG-2575 IN COMBINATION WITH AZA ARE REFERRED TO AS "STUDY DRUGS."
Technical Summary
- MULTICENTER, DOUBLE-BLIND, RANDOMIZED, GLOBAL, PHASE 3 REGISTRATION STUDY OF LISAFTOCLAX (APG-2575) IN COMBINATION WITH AZACITIDINE (AZA) IN PATIENTS WITH NEWLY DIAGNOSED HIGHER-RISK MYELODYSPLASTIC SYNDROME (HR-MDS) (GLORA-4).
- Code EudraCT: 2024-517247-31
- Protocol number: APG2575MG301
- Promoter: Ascentage Pharma Group Inc
- Molecule/Drug: lisaftoclax (APG-2575) en combinación con azacitidina (AZA)
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