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.
Plain-language title generated from the registry record
Registry title: Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).
Key facts
- Where
- Angers, Le Mans Cedex 9, Limoges, Nantes, Nantes Cedex 2, Nice, Orleans Cedex 2, Paris, Pessac, Poitiers, Pontoise, Tours Cedex 9, and Villejuif, FranceSee the 13 sites
- Phase
- Phase 3
Where in France
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier Le MansLe Mans Cedex 9, FranceTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- L'Hopital Prive Du ConfluentNantes Cedex 2, FranceTaking people
- Centre Hospitalier Universitaire de NiceNice, FranceTaking people
- Centre Hospitalier Universitaire D OrleansOrleans Cedex 2, FranceTaking people
- Hopital Saint LouisParis, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascentage Pharma Group Inc.
- Trial code
- NCT06641414EU 2024-517247-31-00
- Record updated
- 13 October 2026
- Original 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.Read full original descriptionShow less
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).
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.
Inclusion: 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: 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.