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

• Status: Recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

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.