Status:
ACTIVE_NOT_RECRUITING
The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Refractory/Relapsed Autoimmune Hemolytic Anemia
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04398459
Start Date
May 1 2020
End Date
June 30 2025
Last Update
September 25 2024
Active Locations (3)
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1
Zhoukou Central Hospital
Zhoukou, Henan, China
2
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China
3
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China