Clinical Trial

Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).

Recruiting Phase 3
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-10-12; most recent amendment 2025-11-18.
Status change: Not Yet Recruiting → Recruiting 2025-02-18
Trial Details
NCT Number NCT06641414
Lead Sponsor Ascentage Pharma Group Inc.
Conditions Higher-risk Myelodysplastic Syndrome
Enrollment 490 participants
Start Date 2025-01-22
Primary Completion 2029-06 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-20