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

Acquired Pure Red Cell Aplasia Clinical Trial

— BID-PERAL  

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04423367
• Other study ID #: IHBDH-IIT2020010
• Status: Terminated
• Phase: Phase 2
• Start date: September 13, 2020
• Est. completion date: February 6, 2024

Study information

• Verified date: February 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 6, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Pure Red Cell Aplasia
• Recurrence
• Red-Cell Aplasia, Pure

Intervention

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

Locations

Country	Name	City	State
China	The Second Affilated Hospital of Shandong First Medical University	Tai'an	Shandong
China	Regenerative Medicine Center	Tianjin
China	Zhoukou Central Hospital	Zhoukou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		within 12 weeks
Secondary	Frequency and severity of adverse events and severe adverse events		within 12 weeks
Secondary	Relapse free survival		within 24 and 48 weeks