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

  • End date
    Jun 30, 2024
  • participants needed
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 23 August 2023


This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

Condition Refractory/Relapsed Autoimmune Hemolytic Anemia
Treatment Ibrutinib
Clinical Study IdentifierNCT04398459
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on23 August 2023


Yes No Not Sure

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
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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