Actively Recruiting
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
Led by Ascentage Pharma Group Inc. · Updated on 2025-11-20
490
Participants Needed
2
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
MD Anderson Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100033
Actively Recruiting
Research Team
Y
Yifan Zhai, M.D., Ph.D.
CONTACT
Q
Qian Niu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here