NCT06104566

Global Trial in APG2575 for Patients With CLL/SLL

A Global Multicenter, Open Label, Randomized Phase 3 Registrational Study of Lisaftoclax (APG-2575) in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Detailed description

Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.

Conditions

• CLL/SLL

Interventions

Type	Name	Description
DRUG	lisaftoclax +BTK inhibitor	lisaftolax + BTK inhibitor
DRUG	BTK inhibitor	BTK inhibitor

Timeline

• Start date: 2023-12-20
• Primary completion: 2025-10-20
• Completion: 2027-10-31
• First posted: 2023-10-27
• Last updated: 2025-09-18

Locations

2 sites across 2 countries: United States, Russia

Regulatory

• FDA-regulated drug study