NCT06319456

A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.

A Global Multicenter, Open Label, Randomized Phase III Confirmatory Study of Lisaftoclax (APG-2575) in Combination With Acalabrutinib Versus Immunochemotherapy in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (GLORA-2).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 344 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL.

Detailed description

The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).

Conditions

• CLL/SLL

Interventions

Type	Name	Description
DRUG	Lisaftoclax (APG-2575)	QD, oral administration, every 28 days for a dosing cycle.
DRUG	Acalabrutinib	BID, oral administration, every 28 days for a dosing cycle.
DRUG	Fludarabine	Every 28 days for a treatment cycle, administration of 6 cycles.
DRUG	Cyclophosphamide，CTX	Every 28 days for a treatment cycle, administration of 6 cycles.
DRUG	Rituximab	Every 28 days for a treatment cycle, administration of 6 cycles.
DRUG	Chlorambucil	Every 28 days for a treatment cycle, administration of 6 cycles.

Timeline

• Start date: 2024-04-07
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2024-03-20
• Last updated: 2024-05-29

Locations

6 sites across 1 country: China