NCT05870475 Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
| NCT ID | NCT05870475 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Polycythemia Vera |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2028-03-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Study purpose: To compare the efficacy and safety of pegylated interferon α-2b in combination with ruxolitinib versus pegylated interferon α-2b alone for treating hydroxyurea-resistant or hydroxyurea-intolerant polycythemia vera.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old. * Male or Female. * Meets the diagnostic criteria for Polycythemia Vera according to WHO-2022. * Resistant or intolerant to hydroxyurea (based on the 2013 European LeukemiaNet criteria). * Have not previously received interferon preparations or ruxolitinib treatment, or the washout period between the last use of interferon preparations or ruxolitinib and the first use of the study drug should not be less than 4 weeks. * Patients with indications for cytoreductive therapy. * During screening, female hemoglobin (HGB) ≥10g/dL, male hemoglobin (HGB) ≥11g/dL; neutrophil count ≥1.5×109/L; platelet count ≥100×109/L. * Voluntary written informed consent. Exclusion Criteria: * Symptomatic splenomegaly; * Contraindications to interferon or ruxolitinib therapy; * Severe or significant comorbidities that may affect the participant's ability to participate in the study, as determined by the investigator; * History of major organ transplantation; * Pregnant or br