Testing Ruxolitinib with Pegylated Interferon for Polycythemia Vera
Compares two treatments in adults with polycythemia vera who cannot tolerate or respond to hydroxyurea.
Plain-language title generated from the registry record
Registry title: Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with polycythemia vera whose disease no longer responds to hydroxyurea or who cannot tolerate it. It compares pegylated interferon α-2b plus ruxolitinib with pegylated interferon α-2b alone.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Polycythemia vera diagnosed by the WHO-2022 criteria, with an indication for cytoreductive therapy (treatment to lower blood cell counts).
- Earlier treatment
- Resistant or intolerant to hydroxyurea (2013 European LeukemiaNet criteria). No earlier interferon or ruxolitinib, or at least 4 weeks since the last dose.
- Biomarker or test result
- Blood counts at screening: hemoglobin ≥10g/dL for women and ≥11g/dL for men, neutrophils ≥1.5×109/L, platelets ≥100×109/L.
Main reasons for not taking part
- Symptomatic splenomegaly (enlarged spleen with symptoms)
- Pregnant or breastfeeding women
- Autoimmune disease, including autoimmune thyroid disease (controlled hypothyroidism on thyroid hormone may be included)
- Active hepatitis or HIV infection, or another clinically significant infection
- Current or past depression, or any suicidal attempt or tendency during screening
Read by machine on 12 November 2026.
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaContact: Lei Zhang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT05870475
- Record updated
- 3 July 2024
- Original description
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.Read full original descriptionShow less
A Randomized Controlled Study Evaluating the Efficacy and Safety of Pegylated Interferon α-2b in Combination With Ruxolitinib vs. Pegylated Interferon α-2b Monotherapy for Treating Hydroxyurea-resistant/Intolerant Polycythemia Vera
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.
Inclusion: ≥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: Contraindications to interferon or ruxolitinib therapy; Use of any investigational drug or participation in any other clinical trial within 4 weeks prior to the first dose of the study drug, or failure to recover from any effects of previously administered study drugs; The investigator deems the presence of any concurrent condition that may jeopardize the safety of the participant or the compliance to the protocol; History of major organ transplantation; History or current diagnosis of autoimmune thyroid disease (patients with controlled hypothyroidism on oral thyroid hormone replacement therapy may be included); Documented evidence of any other autoimmune disease (such as active hepatitis, systemic lupus erythematosus, antiphospholipid antibody syndrome, or autoimmune arthritis); Clinically significant bacterial, fungal, mycobacterial, parasitic, or viral infection such as active hepatitis or HIV infection (patients with acute bacterial infections requiring antibiotic treatment should be deferred from screening/enrollment until completion of antibiotic treatment); Evidence of severe retinopathy or clinically significant ophthalmologic disease (due to diabetes or hypertension); Current clinically significant depression or history of depression, or any suicidal attempt or tendency during screening; Active bleeding or thrombotic complications; History of any malignant tumor within the past 5 years (except for stage 0 chronic lymphocytic leukemia [CLL], cured basal cell carcinoma, squamous cell carcinoma, and superficial melanoma); History of alcohol or substance abuse within the past year; Symptomatic splenomegaly; Severe or significant comorbidities that may affect the participant's ability to participate in the study, as determined by the investigator; Pregnant or breastfeeding women; Presence of blasts in the peripheral blood within the past 3 months.