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OpenTrials
Completed

NCT Number: NCT04423367

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zhoukou Central Hospital, Zhoukou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bortezomib/dexamethasone

Drug

Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.

Primary outcomes

  1. Overall response rate

    Time frame: within 12 weeks

Secondary outcomes

  1. Frequency and severity of adverse events and severe adverse events

    Time frame: within 12 weeks

  2. Relapse free survival

    Time frame: within 24 and 48 weeks

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Acronym: BID-PERAL

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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