Ireland
--:--IST
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 Germany tracker
Phase
Phase 3
Started
2025-01-22
Last updated
2026-10-13

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. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug. 4. MDS or other conditions that cannot be administered enterally. 5. 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 (155)

FacilityCityRegionStatus
Ascentage Investigative Site Birmingham Alabama Not Yet Recruiting
Ascentage Investigative Site Phoenix Arizona Recruiting
Ascentage Investigative Site Los Angeles California Recruiting
Ascentage Investigative Site Sacramento California Recruiting
Ascentage Investigative Site San Diego California Recruiting
Ascentage Investigative Site Aurora Colorado Recruiting
Ascentage Investigative Site Jacksonville Florida Recruiting
Ascentage Investigative Site Chicago Illinois Recruiting
Ascentage Investigative Site Indianapolis Indiana Recruiting
Ascentage Iowa City Iowa Not Yet Recruiting
Ascentage Investigative Site Louisville Kentucky Recruiting
Ascentage Investigative Site Baltimore Maryland Recruiting
Ascentage Investigative Site Minneapolis Minnesota Recruiting
Ascentage Investigative Site Rochester Minnesota Recruiting
Ascentage Investigative Site St Louis Missouri Recruiting
Ascentage Investigative Site Lincoln Nebraska Recruiting
Ascentage Investigative Site Hackensack New Jersey Recruiting
Ascentage Investigative Site New York New York Recruiting
Ascentage Investigative Site Rochester New York Recruiting
Ascentage Investigative Site The Bronx New York Recruiting
Ascentage Investigative Site Charlotte North Carolina Recruiting
Ascentage Investigative Site Durham North Carolina Recruiting
Ascentage Investigative Site Winston-Salem North Carolina Recruiting
Ascentage Investigative Site Cleveland Ohio Recruiting
Ascentage Investigative Site Columbus Ohio Recruiting
Ascentage Investigative Site Eugene Oregon Recruiting
Ascentage Investigative Site Pittsburgh Pennsylvania Recruiting
Ascentage Investigative Site Providence Rhode Island Not Yet Recruiting
Ascentage Investigative Site Austin Texas Recruiting
Ascentage Investigative Site Houston Texas Recruiting
Ascentage Investigative Site Tyler Texas Recruiting
Ascentage Investigative Site Charlottesville Virginia Recruiting
Ascentage Investigative Site Manassas Virginia Recruiting
Ascentage Investigative Site Norfolk Virginia Recruiting
Ascentage Investigative Site Edmonds Washington Recruiting
Ascentage Investigative Site Issaquah Washington Recruiting
Ascentage Investigative Site Seattle Washington Recruiting
Ascentage Investigative Site Seattle Washington Recruiting
Ascentage Investigative Site Milwaukee Wisconsin Recruiting
Ascentage Investigative Site Waukesha Wisconsin Recruiting

+ 115 more sites — see the full list on the official registry below.

More Ascentage Pharma Group Inc. trials in Germany

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 Germany