Informations générales (source: ClinicalTrials.gov)
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).
Interventional
Phase 3
Ascentage Pharma Group Inc. (Voir sur ClinicalTrials)
janvier 2025
décembre 2029
19 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe WILLEKENS | 16/10/2026 02:25:17 | Contacter | ||
Critères
Tous
1. Newly diagnosed higher-risk MDS.
2. ECOG score of ≤2.
3. Expected survival ≥ 3 months.
4. Adequate organ function.
5. 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.
6. 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.
7. Subjects are able to complete study procedures and follow-up examinations.
Exclusion Criteria:
1. Concomitant other malignancies or prior malignancies with disease-free intervals of
less than 1 year at the time of signing the informed consent.
2. Have undergone hematopoietic stem cell transplantation.
3. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within
14 days prior to the first dose of study drug.
4. MDS or other conditions that cannot be administered enterally.
5. Any condition that the subject is deemed to be inappropriate to participate in this
study after evaluation by the investigator.