Status:
COMPLETED
Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acquired Pure Red Cell Aplasia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.
Eligibility Criteria
Inclusion
- ECOG ≤ 2.
- Age from 18 to 70.
- Diagnosed with acquired pure red cell aplasia.
- Meets the criteria of first-line treatment failure or relapse.
- Organs in good function.
- Signed informed consent.
Exclusion
- Nursing woman.
- Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc.
- Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc.
- Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma.
- Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation.
- Secondary PRCA caused by solid tumors except for thymoma.
- Secondary PRCA caused by drugs or pregnancy.
- Secondary PRCA caused by the B19 virus.
- Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities.
- Previously received treatment in other trials within 4 weeks before enrollment.
- Previously treated with the proteasome inhibitor.
- Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment.
- Have a history of malignant tumors.
- Have a history of mental illness.
- Inability to understand or to follow study procedures.
Key Trial Info
Start Date :
September 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04423367
Start Date
September 13 2020
End Date
September 30 2024
Last Update
November 18 2024
Active Locations (3)
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1
Zhoukou Central Hospital
Zhoukou, Henan, China
2
The Second Affilated Hospital of Shandong First Medical University
Tai’an, Shandong, China
3
Regenerative Medicine Center
Tianjin, China