NCT04398459
Recruiting
Phase 2
A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic
Institute of Hematology & Blood Diseases Hospital, China3 sites in 1 country18 target enrollmentMay 1, 2020
Overview
- Phase
- Phase 2
- Intervention
- Ibrutinib
- Conditions
- Refractory/Relapsed Autoimmune Hemolytic Anemia
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Overall response rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Jun Shi
Director, Regenerative Medicine Clinic Center
Institute of Hematology & Blood Diseases Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Age from 6 to
- •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.
Exclusion Criteria
- •Nursing woman
- •Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
- •Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
- •Secondary AIHA caused by drugs or infection.
- •Received rituximab in 8 weeks before enrollment.
- •Previously received treatment with BTK inhibitor.
- •Previously received organ or stem cell transplantation.
- •Have a history of thrombosis or organ infarction.
- •Diagnosed with an active stage of connective tissue disease.
- •Have a history of lymphoproliferative tumors or any other malignant tumors.
Arms & Interventions
iBRIAN
Intervention: Ibrutinib
Outcomes
Primary Outcomes
Overall response rate
Time Frame: within 12 weeks
Secondary Outcomes
- Incidence of adverse events and severe adverse events(within 48 weeks)
- Relapse free survival rate(within 48 weeks)
Study Sites (3)
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