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)
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)
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
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.
Inclusion Criteria:
Age ≥ 18 years.
Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
ECOG Performance Status grade 0-2
Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:
Adequate renal function
Adequate liver function as indicated by:
Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
shanthi.marur@ascentage.com3017925062
yzhai@ascentage.com301-549-6188
Tuscon, Arizona 85742, United States
Gurugramam, Haryana 122001, India
Gurugramam, Haryana 122002, India
Saint Petersburg, Kaluga Oblast 248008, Russia