The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Zanubrutinib was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate
The percentage of patients achieved complete response, complete response with incomplete hemolysis recovery, and partial response.
Time frame: within 12 weeks
Incidence of adverse events and severe adverse events
Time frame: within 24 weeks
Relapse free survival rate
Time frame: within 48 weeks
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