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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-08

Study Completion Date

2029-10-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of MGTA-145 and Plerixafor in Patients With Sickle Cell Disease

NCT05445128

Sickle Cell Disease

TERMINATED PHASE2

Endoplasmic Reticulum Stress and Resistance to Treatments in Ph-negative Myeloproliferative Neoplasms

NCT02823184

Polycythemia Vera Essential Thrombocythemia

COMPLETED

Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply

NCT04182100

Polycythemia Vera (PV)

COMPLETED PHASE2

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

NCT06290765

Polycythemia Vera Myeloproliferative Neoplasm

NOT_YET_RECRUITING PHASE4

Genomic Screening for Hereditary Erythrocytosis and Related Diseases

NCT03263364

Hereditary Erythrocytosis/Idiopathic Erythrocytosis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myeloproliferative Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Next-generation sequencing

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cytokines

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No