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Recruiting Phase 3

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

NCT06641414 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2025-01-22
Last updated
2025-11-20

Condition(s) studied

Higher-risk Myelodysplastic Syndrome

Investigational drug(s) / intervention(s)

Lisaftoclax (APG-2575) →Azacitidine Injection →Placebo

Lisaftoclax (APG-2575): QD, oral administration.

Azacitidine Injection: QD, hypodermic or intravenous injection.

Placebo: QD, oral administration.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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. 6. 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. 7. Subjects are able to complete study procedures and follow-up examinations. Exclusion Criteria: 1. Concomitant other malignancies or prior malignancies with disease-free intervals of less 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 this study after evaluation by the investigator.

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
MD Anderson Cancer Center Houston Texas Recruiting
Peking University People's Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06641414 on ClinicalTrials.gov ↗ ← All trials in Australia