drugset / Trial / NCT06319456

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

NCT06319456

Phase 3 Recruiting 344 enrolled Ascentage Pharma Group Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-04-07
Primary completion
2027-08
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject APG-2575 Small molecule Oral
Subject Acalabrutinib Small molecule Oral
Comparator Chlorambucil Other / unclassified
Comparator Cyclophosphamide Other / unclassified
Comparator Fludarabine Small molecule
Comparator Rituximab Monoclonal antibody