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New treatment option for Polycythemia Vera
Official title Pegylated Interferon α-2b in Combination With Ruxolitinib for Treating Hydroxyurea-resistant/Intolerant PV
ClinicalTrials.gov ID: NCT05870475
What this study is testing
What is Ruxolitinib?
Ruxolitinib is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for polycythemia vera.
Also referred to as RUX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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...
You likely can't join if
- 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 breastfeeding women;
- History or current diagnosis of autoimmune thyroid disease (patients with controlled hypothyroidism on oral thyroid hormone replacement therapy may...
See the full eligibility 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...
- 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.
- 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 breastfeeding women;
- 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...
- 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;
- Presence of blasts in the peripheral blood within the past 3 months;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.