Overview
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
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.