NCT06389292

A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia

A Global, Multicenter, Randomized, Double-blind, Phase 3 Pivotal Registrational Clinical Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (GLORA-3)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (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, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.

Detailed description

The newly diagnosed acute myeloid leukemia, who are not eligible for standard induction chemotherapy, will be randomized to the investigational group 'Lisaftoclax (APG-2575) + AZA' or the control group 'placebo+ AZA'.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	APG-2575(Lisaftoclax )	QD, oral administration, every 28 days for a dosing cycle.
OTHER	Placebo	QD, oral administration, every 28 days for a dosing cycle.
DRUG	Azacitidine Injection	QD, subcutaneous or intravenous injection, D1-7 in 28-day cycle.

Timeline

• Start date: 2024-06-11
• Primary completion: 2028-05-25
• Completion: 2029-03-26
• First posted: 2024-04-29
• Last updated: 2025-11-25

Locations

6 sites across 2 countries: China, Russia