NCT06641414 · Ascentage Pharma Group Inc.
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
What this study is about
A global conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, pivotal phase III study. To evaluate how long patients live (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.
View original scientific description
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.
Interventions
DRUG
Lisaftoclax (APG-2575)
QD, oral administration.
DRUG
Azacitidine Injection
QD, hypodermic or intravenous injection.
OTHER
Placebo
QD, oral administration.
Primary outcome measures
Overall Survival（OS）
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Birmingham, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Sacramento, California
- San Diego, California
- Aurora, Colorado
- Jacksonville, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Iowa City, Iowa
- Louisville, Kentucky
- Baltimore, Maryland
And 27 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations