This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Overall response rate (ORR) by Independent Review Committee
Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
Time frame: up to 6 months
Overall response rate (ORR) assessed by Investigator
Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
Time frame: up to 6 months
Duration of response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 12 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: up to 6 months
Disease control rate(DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 12 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: up to 24 months
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