This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
The First Affiliate Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Overall response rate (ORR) assessed by Independent Review Committee
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC
Time frame: Baseline up to 18 months
Overall response rate (ORR) assessed by Investigator
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
Time frame: Baseline up to 18 months
Duration of disease remission (DOR)
The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).
Time frame: Baseline up to 18 months
Progression-free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause
Time frame: Baseline up to 18 months
Disease control rate(DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: Baseline up to 18 months
Overall Survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time frame: Baseline up to 24 months
Incidence of Adverse Events, Serious Adverse Events
AE, SAE, and withdrawal from the trial for reasons such as safety or tolerability.
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The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Time frame: Baseline up to 18 months