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Combination Therapy with Interferon-Alpha2a and Ruxolitinib in Newly Diagnosed Patients with Polycythemia Vera. A Danish Safety and Efficacy Study.
EU CTIS ID: 2024-518216-39-00
What this study is testing
Safety profile of COMBI therapy in patients with polycythemia Vera after 24 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant must meet criteria 1–3 AND at least one of 4–8 1. Age ≥ 18 years AND 2. A confirmed diagnosis of PV according to the WHO 2016 criteria AND 3. A negative test for active or latent tuberculosis (from within the last month) 4. Biochemical evidence of active disease as defined by a) Elevated hematocrit and/or red cell count and/or b) Leucocyte count > 10 x 109/L and/or c) Platelet count > 400 x 109/L. OR 5. Hypermetabolic symptoms such as weight loss (> 10% within 6 months), night sweats and subfebrilia (temperature> 38 º C for more than 2 weeks without signs of infection OR 6. Pruritus OR 7. Symptomatic splenomegaly OR 8. Presence of previous thrombosis
You likely can't join if
- 1. Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug. Participants must use contraceptives during the entire study period*. 2. Other active malignancy within the past 5 years (not including non-melanoma skin cancer and prostate cancer without need for treatment). 3. ECOG function scores> / = 3 4. Serum creatinine more than 2 x ULN 5. Total serum bilirubin greater than 1.5 x ULN 6. Plasma ALAT more than 3 x ULN 7. Former psychiatric disorder (depression diagnosed by a psychiatrist) 8. Uncontrolled metabolic (endocrinological) disease. 9. Severe heart disease (heart failure NYHA class 3-4). 10. Severe myelosuppression. (WBC<1.5 Mill/L, PLA<100) 11. Chronic hepatitis with decompensated cirrhosis. 12. Chronic hepatitis in patients who have been or recently (within 6 months) has been treated with immunosuppressive drugs except for corticosteroid treatment. 13. Epilepsy and / or other serious CNS disorders. *Spiral, birth control pills, implants, transdermal patch, vaginal ring or transdermal injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile, one must generally be surgically sterilized (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months before study enrollment.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.