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

Overview

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.

Full Title of Study: “Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2024

Interventions

  • Drug: bortezomib/dexamethasone
    • Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.

Arms, Groups and Cohorts

  • Experimental: bortezomib/dexamethasone
    • Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.

Clinical Trial Outcome Measures

Primary Measures

  • Overall response rate
    • Time Frame: within 12 weeks

Secondary Measures

  • Frequency and severity of adverse events and severe adverse events
    • Time Frame: within 12 weeks
  • Relapse free survival
    • Time Frame: within 24 and 48 weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Hematology & Blood Diseases Hospital, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jun Shi, Director, Regenerative Medicine Clinic Center – Institute of Hematology & Blood Diseases Hospital, China
  • Overall Official(s)
    • Jun Shi, PhD, Principal Investigator, Institute of Hematology & Blood Diseases Hospital, China

References

Zhang L, Chen N, Xu Z, Liang Q, Pan H, Zhao J, Fang L, Shi J. Good treatment-free survival of monoclonal gammopathy of undetermined significance associated pure red cell aplasia after bortezomib plus dexamethasone. Blood Cells Mol Dis. 2021 Jul;89:102573. doi: 10.1016/j.bcmd.2021.102573. Epub 2021 Apr 27.

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