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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Higher-risk Myelodysplastic Syndrome

In brief

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.

Key facts

Study ID

NCT06641414

Run by

Ascentage Pharma Group Inc.

People needed

490

Starts

2025-01-22

Expected to finish

2029-12-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed higher-risk MDS.
• ECOG score of ≤2.
• Expected survival ≥ 3 months.
• Adequate organ function.
• Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.
• Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.
• Subjects are able to complete study procedures and follow-up examinations.

You may not qualify if…

• Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.
• Have undergone hematopoietic stem cell transplantation.
• Uncontrolled active infection
• Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.
• MDS or other conditions that cannot be administered enterally.
• Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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