GLORA Study
Research type
Research Study
Full title
A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Lisaftoclax (APG2575) in Previously Treated Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
IRAS ID
1009069
Contact name
Wendy Chu
Contact email
Sponsor organisation
Ascentage Pharma Group Inc.
Eudract number
2023-508005-24
Clinicaltrials.gov Identifier
Research summary
This study is looking at patients with a condition called Chronic Lymphocytic Leukaemia (CLL) who are already taking a drug called Acalabrutinib. Patients may be receiving acalabrutinib as first, second or third line therapy for at least 12 months but have failed to control their CLL completely or have high risk disease features. This aim of this study is to find out if adding a new drug called Lisaftoclax to the existing acalabrutinib treatment improves control and/or delays the participant’s CLL from progressing.
In this study, half of the participants will be asked to stay on acalabrutinib alone. The other half of the participants will be asked to take Lisaftoclax in addition to their existing acalabrutinib therapy. A computer will decide by chance (like tossing a coin) which of these two treatment arms, participants will be allocated to. This will help us to know whether adding Lisaftoclax truly gives patients a longer period of disease control.REC name
HSC REC A
REC reference
24/NI/0028
Date of REC Opinion
20 Mar 2024
REC opinion
Further Information Favourable Opinion