Lisaftoclax and Azacitidine for Higher-Risk Myelodysplastic Syndrome

This study is testing a new combination treatment for people with newly diagnosed higher-risk Myelodysplastic Syndrome (MDS), a type of blood cancer. It combines Lisaftoclax (APG-2575) with Azacitidine Injection, and compares it to Azacitidine Injection plus a placebo (an inactive pill). The study aims to see if adding Lisaftoclax improves how long people live (Overall Survival). You may be able to join if you are 18 or older, have newly diagnosed higher-risk MDS, an ECOG score of 2 or less (a measure of your physical ability), and good organ function. The study is currently unclear on its recruitment status and plans to enroll 490 participants.

Study design
This is a global, multi-center study that is randomized, double-blind (neither you nor your doctor will know which treatment you receive), and placebo-controlled. It is a pivotal Phase III study and plans to enroll 490 participants.
What's involved
You would receive either Lisaftoclax (APG-2575) by mouth daily, or a placebo by mouth daily. All participants will also receive Azacitidine Injection daily, either under the skin or into a vein.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long participants live for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06641414

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ascentage Pharma Group Inc.
~490 participants
Updated 2025-11-20 on ClinicalTrials.gov
What's tested:Lisaftoclax (APG-2575)Azacitidine InjectionPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival(OS)
Measured over Up to 5 years
Higher-risk Myelodysplastic Syndrome
2 sites across 2 states
Texas1
Beijing Municipality1
  • Xiaojun Huang, M.D., Ph.D. · STUDY_CHAIR · Peking University People's Hospital
  • Guillermo Garcia-Manero, M.D. · STUDY_CHAIR · M.D. Anderson Cancer Center

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  • Overall Survival(OS)Up to 5 years

    The primary endpoint was overall survival (OS), defined as the time from the date of randomization to the date of death of any cause.