Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2020-05-01
Last updated
2024-09-25
Condition(s) studied
Refractory/Relapsed Autoimmune Hemolytic Anemia
Investigational drug(s) / intervention(s)
Ibrutinib
Ibrutinib: Each recruited subject will accept Ibrutinib treatment.
Study 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
Sex
ALL
Min age
6 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall response rate — within 12 weeks
Trial sites (3)
Facility
City
Region
Status
Zhoukou Central Hospital
Zhoukou
Henan
The Second Affilated Hospital of Shandong First Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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