Refractory/Relapsed Autoimmune Hemolytic Anemia
Conditions
Keywords
Ibrutinib, BTK Inhibitor, autoimmune hemolytic anemia, AIHA
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.
Interventions
DRUGIbrutinib
Each recruited subject will accept Ibrutinib treatment.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | within 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events and severe adverse events | within 48 weeks |
| Relapse free survival rate | within 48 weeks |
Countries
China
Outcome results
None listed