The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Phase 2
Recruiting
- Conditions
- Refractory/Relapsed Autoimmune Hemolytic Anemia
- Interventions
- Registration Number
- NCT04398459
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description iBRIAN Ibrutinib -
- Primary Outcome Measures
Name Time Method Overall response rate within 12 weeks
- Secondary Outcome Measures
Name Time Method Incidence of adverse events and severe adverse events within 48 weeks Relapse free survival rate within 48 weeks
Trial Locations
- Locations (3)
Zhoukou Central Hospital
🇨🇳Zhoukou, Henan, China
The Second Affilated Hospital of Shandong First Medical University
🇨🇳Tai'an, Shandong, China
Regenerative Medicine Center
🇨🇳Tianjin, Tianjin, China