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

Last updated: November 18, 2025
Sponsor: Ascentage Pharma Group Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Myelodysplastic Syndromes (Mds)

White Cell Disorders

Treatment

Placebo

Lisaftoclax (APG-2575)

Azacitidine Injection

Clinical Study ID

NCT06641414
APG2575MG301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Newly diagnosed higher-risk MDS.

  2. ECOG score of ≤2.

  3. Expected survival ≥ 3 months.

  4. Adequate organ function.

  5. Female subjects of potential childbearing potential have a negative urine or serumpregnancy test before dosing. Subjects of childbearing potential as well as theirpartners voluntarily use contraception deemed effective by the investigator duringthe treatment period and for at least six months after the last dose of study drug.

  6. Able to understand and voluntarily sign a written informed consent form, which mustbe signed prior to the performance of any trial-specified study procedures.

  7. Subjects are able to complete study procedures and follow-up examinations.

Exclusion

Exclusion Criteria:

  1. Concomitant other malignancies or prior malignancies with disease-free intervals ofless than 1 year at the time of signing the informed consent.

  2. Have undergone hematopoietic stem cell transplantation.

  3. Uncontrolled active infection

  4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.

  5. MDS or other conditions that cannot be administered enterally.

  6. Any condition that the subject is deemed to be inappropriate to participate in thisstudy after evaluation by the investigator.

Study Design

Total Participants: 490
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 22, 2025
Estimated Completion Date:
December 31, 2029

Study Description

This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100033
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing 1816670, Beijing Municipality 2038349 100033
    China

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77054
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

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