The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China