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

Inclusion Criteria:

• 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 informedconsent.

Exclusion Criteria:

• Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutininsyndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
• Diagnosis of active stage of connective tissue disease.
• History of lymphoproliferative tumors or any other malignant.
• Diagnosis of other inherited or acquired hemolytic diseases.
• Secondary AIHA caused by drugs or infection.
• Previously received organ or stem cell transplantation.
• History of thrombosis or organ infarction.
• Received rituximab within 8 weeks before enrollment.
• Previously treated with BTK inhibitor ≥ 2 weeks.
• Received low-molecular-weight heparin or warfarin within 1 week before enrollment andneed to continue the drug treatment.
• Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment and needto continue the drug treatment.
• Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoingsigns/symptoms related to the infection without improvement despite appropriateantibiotics, antiviral therapy, and/or other treatment), known human immunodeficiencyvirus (HIV), known evidence of active infectious hepatitis B, and/or known evidence ofactive hepatitis C.
• Any severe and/or uncontrolled medical conditions: refractory hypertension, clinicallysignificant cardiac diseases, renal diseases, liver diseases and metabolic diseases,etc.
• History of mental illness.
• Participation in another clinical trial within 4 weeks before the start of this trial.
• Pregnant or breast-feeding patients.
• Patients considered ineligible for the study by the investigator for reasons otherthan the above.