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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    17
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 26 January 2021

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.

Details
Condition Acquired Pure Red Cell Aplasia
Treatment bortezomib/dexamethasone
Clinical Study IdentifierNCT04423367
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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, waldenstrm 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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