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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517247-31-00

Acronym

APG2575MG301

Enrollment

371

Registered

2025-04-22

Start date

2025-07-07

Completion date

Unknown

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly Diagnosed Higher Risk Myelodysplastic Syndrome

Brief summary

xxx, xxx

Detailed description

To compare the efficacy of xxx, To evaluate the safety of xxx, To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx, To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).

Interventions

DRUGAzacitidine Seacross 25 mg/mL powder for suspension for injection

DRUGPlacebo (Lisaftoclax)

DRUGLisaftoclax

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
xxx, xxx	—

Secondary

Measure	Time frame
To compare the efficacy of xxx, To evaluate the safety of xxx, To evaluate the population pharmacokinetics (Pop PK) following treatment with xxx, To evaluate Health Economics Outcomes Research (HEOR) measures of lisaftoclax xxx based on EuroQol 5 Dimension (EQ-5D).	—

Countries

Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026

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)