Predicting response to hydroxyurea or pegylated interferon in polycythemia vera, essential thrombocythemia, and pre-myelofibrosis
Official title: Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
Run by University Hospital, Angers · NCT05440838 · Data updated 2026-11-12
We will test whether genetic mutations and cytokine levels at diagnosis can predict who will respond to hydroxyurea or pegylated interferon in people with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | ruxolitinib |
| Locations | 6 sites (Angers and 5 other locations) |
| Status | Recruiting |
| Started | May 17, 2023 |
| Main results expected | February 17, 2027 |
| Study ends | February 17, 2032 |
| Registry record updated | March 6, 2026 |
| Trial ID | NCT05440838 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis who are treatment-naïve and preparing to start first-line hydroxyurea or pegylated interferon, able to consent and affiliated to social security.
✕Probably not a fit
Patients who have received prior cytoreductive treatment, have overt myelofibrosis or another active cancer, or are being treated only with phlebotomy or with drugs such as ruxolitinib, anagrelide, or pipobroman are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, exploratory project will enroll adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis who are starting first-line hydroxyurea or pegylated interferon. Researchers will use next-generation sequencing to characterize mutational profiles and measure cytokine levels at diagnosis, then follow hematological response at 12 months. Statistical analyses will examine associations between genetic/cytokine markers and response or loss of response. The study excludes patients with prior cytoreductive therapy, overt myelofibrosis, or other active malignancies and is conducted across several French university hospitals.
Why it matters
Potential benefit: If successful, this could identify patients unlikely to respond to hydroxyurea or pegylated interferon so alternative treatments can be considered earlier.
How similar studies have gone: Retrospective work has linked additional somatic mutations to poorer outcomes, but prospective evidence that mutational or cytokine profiles reliably predict first-line treatment response is limited, so this approach remains partly supported but exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis. * Indication for first-line treatment with hydroxyurea or pegylated interferon. * Consent to participate. * Affiliated to social security. Exclusion Criteria: * Previous treatment. * Other on-going malignancy, including overt myelofibrosis. * Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.
Where it's running
-
Chu Angers
Angers, France Recruiting -
Chu Brest
Brest, France Recruiting -
Chu Nantes
Nantes, France Recruiting -
Chu Poitiers
Poitiers, France Recruiting -
Chu Rennes
Rennes, France Recruiting -
Chu Tours
Tours, France Recruiting
Study contacts
- Study coordinator: Corentin Orvain, Doctor
- Email: Corentin.Orvain@chu-angers.fr
- Phone: +3302 41 35 44 75
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Caris Chromoseq data collection for AML, MDS, and MPN
This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.
-
Using NETosis blood markers to predict clot risk in JAK2-positive myeloproliferative neoplasms
This study will try to see if blood markers of NETosis can predict clotting risk in people with JAK2V617F-positive myeloproliferative neoplasms who are at high risk for thrombosis.
-
CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant
This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.
-
Vedolizumab with post-transplant cyclophosphamide and short-course tacrolimus to prevent graft-versus-host disease after reduced-intensity allogeneic stem cell transplant
This trial tests whether adding vedolizumab to post-transplant cyclophosphamide and a short course of tacrolimus can prevent graft-versus-host disease in adults getting reduced-intensity allogeneic stem cell transplants for leukemias or related blood disorders.
-
Study of characteristics and complications in young patients with myeloproliferative neoplasia
This study is trying to gather information about young people under 30 with myeloproliferative neoplasia to better understand their health and complications.
-
Using Sorafenib to Prevent Relapse After Stem Cell Transplantation
This study is testing if the drug sorafenib can help prevent relapse in patients with high-risk blood cancers after they receive a stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.