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ClinicalTrials.gov ID

NCT05440838

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Recruiting

Study Type

Observational

Enrollment

120Estimated

Last Update Posted

Mar 6, 2026Actual

Start Date

May 17, 2023Actual

Primary Completion Date

Feb 17, 2027Estimated

Completion Date

Feb 17, 2032Estimated

Official Title

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

Brief 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.

• Myeloproliferative Neoplasm

• Next-generation sequencing

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, AngersOTHER_GOV

Collaborators

University Hospital, BrestOTHER

Nantes University HospitalOTHER

Poitiers University HospitalOTHER

Rennes University HospitalOTHER

University Hospital, ToursOTHER

a.machet@chu-tours.fr+3302 47 47 37 12