Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Bortezomib; Dexamethasone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.