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RECRUITING
NCT06389292
PHASE3

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

Sponsor: Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

486

Start Date

2024-06-11

Completion Date

2029-03-26

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

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.

Locations (6)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Moscow Multidisciplinary Clinical Center "Kommunarka"

Moscow, Russia

Botkin Moscow Multidisciplinary Research and Clinical Center

Moscow, Russia

Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

Saint Petersburg, Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia