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.
The patients with newly diagnosed CLL/SLL, who have met all required eligibility criteria, will be randomized to the investigational group (Lisaftoclax in combination with Acalabrutinib) or the control group (immunochemotherapy, CIT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
344
QD, oral administration, every 28 days for a dosing cycle.
BID, oral administration, every 28 days for a dosing cycle.
Every 28 days for a treatment cycle, administration of 6 cycles.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGProgress Free Survival (PFS)
PFS is defined as the time from randomization to disease progression(PD) or death from any cause.
Time frame: Up to 1 year
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who have achieved CR, CRi or PR.
Time frame: Up to 1 year
Minimal Residual Disease (MRD) negativity rate
To observe the proportion of patients with MRD negativity in bone marrow, peripheral blood, either or both.
Time frame: Up to 1 year
Safety evaluation based on the adverse event concurrence
Number of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs) will be evaluated.
Time frame: Up to 1 year
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Every 28 days for a treatment cycle, administration of 6 cycles.
Every 28 days for a treatment cycle, administration of 6 cycles.
Every 28 days for a treatment cycle, administration of 6 cycles.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
NOT_YET_RECRUITINGHenan Provincial Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGThe Second Xiangya Hospital of Center South University
Changsha, Hunan, China
NOT_YET_RECRUITINGTongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITINGHematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITING