Status:
UNKNOWN
The Safety and Efficacy of Zanubrutinib 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
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
- Any severe and/or uncontrolled medical conditions: refractory hypertension, clinically significant cardiac diseases, renal diseases, liver diseases and metabolic diseases, etc.
- History of mental illness.
- Participation in another clinical trial within 4 weeks before the start of this trial.
- Pregnant or breast-feeding patients.
- Patients considered ineligible for the study by the investigator for reasons other than the above.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06021977
Start Date
September 1 2023
End Date
December 31 2025
Last Update
November 29 2023
Active Locations (1)
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1
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China, 300131