drugset / Trial / NCT06641414

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

NCT06641414

Phase 3 Recruiting 490 enrolled Ascentage Pharma Group Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-01-22
Primary completion
2029-06
Completion
2029-12

Drugs

EvaluationDrugModalityDoseRoute
Subject APG-2575 Small molecule Oral
Background Azacitidine Other / unclassified Subcutaneous