NCT06641414

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

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).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 490 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.

Conditions

• Higher-risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Lisaftoclax (APG-2575)	QD, oral administration.
DRUG	Azacitidine Injection	QD, hypodermic or intravenous injection.
OTHER	Placebo	QD, oral administration.

Timeline

• Start date: 2025-01-22
• Primary completion: 2029-06-01
• Completion: 2029-12-01
• First posted: 2024-10-15
• Last updated: 2025-11-20

Locations

2 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study