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

Sponsor
University Hospital, Angers
Study ID
NCT05440838
Status
Recruiting
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Conditions

  • Myeloproliferative Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 1, 2022
Start date
May 17, 2023
Status verified
Mar 2026
Primary completion
Feb 17, 2027
Completion
Feb 17, 2032

Study Design

Enrollment
120 participants (estimated)

Primary Outcome Measure

Complete hematological response [ Time Frame: 12 months ]

Central Contacts

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