A Phase II, Single Center, Open-label Trial to Determine the Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 70
Healthy Volunteers: f
View:
• Age from 6 to 70
• Diagnosis of Coombs-negative AIHA
• Diagnosis of warm AIHA, mixed AIHA or Evans syndrome.
• Meets the criteria of relapsed / refractory AIHA
• ECOG ≤ 3
• Willing and able to comply with the requirements for this study and written informed consent.
Locations
Other Locations
China
Regenerative Medicine Center
RECRUITING
Tianjin
Contact Information
Primary
Weiwang Li, PhD
liweiwang@ihcams.ac.cn
15332132036
Backup
Jingyu Zhao, MPH
zhaojingyu@ihcams.ac.cn
13752253515
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 33
Treatments
Experimental: Zanubrutinib
Each recruited subject will accept Zanubrutinib treatment.
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China