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A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
Sponsor: Ascentage Pharma Group Inc.
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.
Official title: 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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
344
Start Date
2024-04-07
Completion Date
2028-08
Last Updated
2024-05-29
Healthy Volunteers
No
Conditions
Interventions
Lisaftoclax (APG-2575)
QD, oral administration, every 28 days for a dosing cycle.
Acalabrutinib
BID, oral administration, every 28 days for a dosing cycle.
Fludarabine
Every 28 days for a treatment cycle, administration of 6 cycles.
Cyclophosphamide,CTX
Every 28 days for a treatment cycle, administration of 6 cycles.
Rituximab
Every 28 days for a treatment cycle, administration of 6 cycles.
Chlorambucil
Every 28 days for a treatment cycle, administration of 6 cycles.
Locations (6)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Henan Provincial Cancer Hospital
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China