A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic
Who is this study for? Child to adult patients with Autoimmune Hemolytic Anemia
What treatments are being studied? Ibrutinib
Status: Active_not_recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 70
Healthy Volunteers: f
View:
• ECOG ≤ 3
• Age from 6 to 70.
• Diagnosed with WAIHA or MAIHA.
• Meets the criteria of relapsed / refractory AIHA.
• Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
• Signed informed consent.
• Organs in good function.
Locations
Other Locations
China
The Second Affilated Hospital of Shandong First Medical University
Tai’an
Regenerative Medicine Center
Tianjin
Zhoukou Central Hospital
Zhoukou
Time Frame
Start Date: 2020-05-01
Completion Date: 2025-06-30
Participants
Target number of participants: 18
Treatments
Experimental: iBRIAN
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China