The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia (NCT06021977) | Clinical Trial Compass
UnknownPhase 2
The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia
China33 participantsStarted 2023-09-01
Plain-language summary
The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.
Who can participate
Age range6 Years – 70 Years
SexALL
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Inclusion Criteria:
* Age from 6 to 70
* Diagnosis of Coombs-negative AIHA
* Diagnosis of warm AIHA, mixed AIHA or Evans syndrome.
* Meets the criteria of relapsed / refractory AIHA
* ECOG ≤ 3
* Willing and able to comply with the requirements for this study and written informed consent.
Exclusion Criteria:
* Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
* Diagnosis of active stage of connective tissue disease.
* History of lymphoproliferative tumors or any other malignant.
* Diagnosis of other inherited or acquired hemolytic diseases.
* Secondary AIHA caused by drugs or infection.
* Previously received organ or stem cell transplantation.
* History of thrombosis or organ infarction.
* Received rituximab within 8 weeks before enrollment.
* Previously treated with BTK inhibitor ≥ 2 weeks.
* Received low-molecular-weight heparin or warfarin within 1 week before enrollment and need to continue the drug treatment.
* Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment and need to continue the drug treatment.
* Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.…
What they're measuring
1
Overall response rate
Timeframe: within 12 weeks
Trial details
NCT IDNCT06021977
SponsorInstitute of Hematology & Blood Diseases Hospital, China