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A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia
Sponsor: Ascentage Pharma Group Inc.
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
Conditions
Interventions
APG-2575(Lisaftoclax )
QD, oral administration, every 28 days for a dosing cycle.
Placebo
QD, oral administration, every 28 days for a dosing cycle.
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