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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase

Completed

Phase 2

Conditions

Acquired Pure Red Cell Aplasia

Treatments

Drug: bortezomib/dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04423367

IIT2020010

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.