Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT04423367
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04423367
Study Brief:
Protocol Section:
NCT04423367