Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-l… (NCT04423367) | Clinical Trial Compass
CompletedPhase 2
Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment
China18 participantsStarted 2020-09-13
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 understan…
What they're measuring
1
Overall response rate
Timeframe: within 12 weeks
Trial details
NCT IDNCT04423367
SponsorInstitute of Hematology & Blood Diseases Hospital, China