MedTrace Logo

Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.

NCT05440838 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-03-06

No results posted yet for this study

Summary

First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable.

In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response.

This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.

Conditions

  • Myeloproliferative Neoplasm

Interventions

DIAGNOSTIC_TEST

Next-generation sequencing

Next-generation sequencing and cytokine profile will be established in all patients before the start of treatment.

Sponsors & Collaborators

  • University Hospital, Brest

    collaborator OTHER

  • Nantes University Hospital

    collaborator OTHER

  • Poitiers University Hospital

    collaborator OTHER

  • Rennes University Hospital

    collaborator OTHER

  • University Hospital, Tours

    collaborator OTHER

  • University Hospital, Angers

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2027-02-17
Completion
2032-02-17

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05440838 on ClinicalTrials.gov