The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

Study Overview
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Brief Summary
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This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

Official Title
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A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic

Conditions
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Refractory/Relapsed Autoimmune Hemolytic Anemia

Intervention / Treatment
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* Drug: Ibrutinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Have other inherited or acquired hemolytic diseases. Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment. Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment. Have a history of mental illness. Inability to understand or to follow study procedures.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iBRIAN<br> | Drug: Ibrutinib<br>* Each recruited subject will accept Ibrutinib treatment.<br>* Other names: BTK inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | within 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and severe adverse events |  | within 48 weeks | 
| Relapse free survival rate |  | within 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ibrutinib, BTK Inhibitor, autoimmune hemolytic anemia, AIHA