USO 25005
APG2575MG301: 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)
Disease Types: Lymphoma & Hematologic
Eligibility Requirements:
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.
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