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RECRUITING
NCT06641414
PHASE3

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

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Lisaftoclax (APG-2575)

QD, oral administration.

DRUG

Azacitidine Injection

QD, hypodermic or intravenous injection.

OTHER

Placebo

QD, oral administration.

Locations (2)

MD Anderson Cancer Center

Houston, Texas, United States

Peking University People's Hospital

Beijing, Beijing Municipality, China