Under construction – not a live service
Sign in
Taking people in GreecePhase 3

Tests lisaftoclax with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome

Tests lisaftoclax plus azacitidine against placebo in adults with newly diagnosed higher-risk myelodysplastic syndrome.

Key facts

Who runs it
Ascentage Pharma Group Inc.
Where
Alexandroupoli, Athens, Chaïdári, Patra, and Thessaloniki, GreeceSee the 7 sitesAlso in 17 other countries, 146 sites
Registry title
Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
Status
Recruiting
Phase
Phase 3
People taking part
490 people, planned
Started
22 Jan 2025
Expected to end
Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Lisaftoclax (APG-2575)
  • Azacitidine Injection
  • Placebo
Record updated
13 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed higher-risk myelodysplastic syndrome (MDS). It tests lisaftoclax or placebo, each given together with azacitidine.

Age
18 years or older
Sex
All sexes can join
Disease stage
Newly diagnosed higher-risk MDS; ECOG score of 2 or less; expected survival of at least 3 months; adequate organ function
Earlier treatment
No stem cell transplant; no use of moderately potent CYP3A4 inducers or inhibitors within 14 days before the first dose

Main reasons for not taking part

  • Another cancer now, or an earlier cancer with less than 1 year free of disease
  • Earlier stem cell transplant
  • Moderately potent CYP3A4 inducers or inhibitors within 14 days before the first dose
  • MDS or other conditions that do not allow taking the drug by mouth or gut
  • Any condition the investigator judges unsuitable for the trial

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have undergone hematopoietic stem cell transplantation
  • Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug
  • Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent
  • 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 in Greece

Also in 17 other countries, 146 sites

  • University General Hospital of AlexandroupoliAlexandroupoli, GreeceTaking people
  • Alexandra HospitalAthens, GreeceTaking people
  • Evangelismos S AAthens, GreeceTaking people
  • Laiko General Hospital of AthensAthens, GreeceTaking people
  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceTaking people
  • Olympion Therapeftirio General Clinic Of Patras S.A.Patra, GreeceTaking people
  • University General Hospital of Thessaloniki - AHEPAThessaloniki, GreeceTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Lisaftoclax (APG-2575) combined with AzacitidineTreatment being tested

    Treatment: Lisaftoclax (APG-2575) and Azacitidine Injection

  • Placebo combined with AzacitidineExisting treatment, for comparison

    Drug: azacitidine injection QD: hypodermic or intravenous injection

    Treatment: Azacitidine Injection and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).
Plain-language title
Tests lisaftoclax with azacitidine for newly diagnosed higher-risk myelodysplastic syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 October 2026