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).
Ascentage Pharma Group Inc.
Summary
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.
Description
This study intends to enroll patients with HR-MDS to receive the therapy of Lisaftoclax (APG-2575) combined with azacitidine (AZA) or placebo combined with azacitidine.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 a…
Interventions
- DrugLisaftoclax (APG-2575)
QD, oral administration.
- DrugAzacitidine Injection
QD, hypodermic or intravenous injection.
- OtherPlacebo
QD, oral administration.
Locations (2)
- MD Anderson Cancer CenterHouston, Texas
- Peking University People's HospitalBeijing, Beijing Municipality