This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
160 mg bid, po, day 1-21, a maximum of 2 years.
25 mg qd, po, day 1-10, a maximum of 2 years.
2-year recurrence-free survival
Time frame: 2 years after enrollment
Overall survival
Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Time frame: From enrollment to study completion, a maximum of 4.5 years
Overall response rate
ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately)
Time frame: up to 2 year, at the end of maintenance
Complete response rate
CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately)
Time frame: up to 2 year, at the end of maintenance
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