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
- Candiolo, Ferrara, Florence, Meldola, Milan, Novara, Ravenna, Rome, Rozzano, Torino, and Varese, ItalySee the 13 sites
- Phase
- Phase 3
Where in Italy
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
- Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
- Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Azienda Sanitaria Locale Roma 2Rome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTorino, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking 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.