Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma

Summary

This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment. Eligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.

Timeline

Start

2026-03-10

Primary completion

2027-01-01

Completion

2028-03-01

Drugs

Indications