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Myeloproliferative NeoplasmPHEMOPNCT06361641

Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes

A study testing Monocytes signatures in myeloproliferative neoplasms at diagnosis in people with Myeloproliferative Neoplasm and Polycythemia Vera, run by University Hospital, Angers at 3 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Monocytes signatures in myeloproliferative neoplasms at diagnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesFrance
Study dates
29 May 2024to 29 May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of PV, ET, pre-myelofibrosis or primary myelofibrosis according to WHO 2022 criteria (including BOM for ET, premyelofibrosis and primary myelofibrosis)
  • Patient who has not received treatment specific to hemopathy at the time of sampling
  • Obtaining the signature of consent to participate in the study
  • Patient having consented to be included in the "Malignant Hemopathy" collection of Angers University Hospital and in FIMBANK database

Who cannot join

  • Person not affiliated to a social security scheme or beneficiary of such a scheme
  • Patient with another hemopathy or another active cancer at the time of diagnosis
  • Minor patient at diagnosis (< 18 years old)
  • Patient not capable or without agreement from the guardian or legal representative

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France3 sites, 3 recruiting
  • GOUBAND Agathe

    Angers, Maine et Loire, 49933

    Agathe GOUBAND, PharmD, 02 41 35 55 96 ext. 33, Agathe.Gouband@chu-angers.fr

    Damien LUQUE PAZ, PharmD, 02 41 35 53 53 ext. 33, Damien.LuquePaz@chu-angers.fr

    Recruiting
  • BESCOND Charles

    Cholet, Maine et Loire, 49325

    Charles BESCOND, MD, 0241355880, charles.bescond@ch-cholet.fr

    Charles Bescond, MD

    Not yet recruiting
  • TRUCHAN-GRACZYK Malgorzata

    Saumur, Maine et Loire, 49400

    Malgorzata TRUCHAN-GRACZYK, MD, 0241533544 ext. 33, matruchan@ch-saumur.fr

    Malgorzata TRUCHAN-GRACZYK, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes-PHEMOP

Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms

Read the detailed description

Philadelphia-negative myeloproliferative neoplasms (MPN) are clonal disorders of the hematopoietic stem cell characterized by an excessive production of mature myeloid cells. MPNs are characterized by the presence of somatic gain-of-function mutations present in more than 80% of cases and affecting JAK2, CALR or MPL genes. These mutations lead to a constitutive activation of the JAK-STAT signaling pathway at the origin of cell proliferation.

MPN include polycythemia vera (PV), essential thrombocythemia (ET), prefibrotic primary myelofibrosis (pre-PMF), and primary myelofibrosis (PMF). Despite the classification of MPNs into distinct subtypes based on clinical and pathological features, the precise mechanisms underlying the phenotypic diversity within these disorders remain poorly understood. One aspect that has received limited attention is the role of monocytes and macrophages, key components of the innate immune system, in MPN pathogenesis.

Monocytes, circulating precursors of tissue-resident macrophages, play essential roles in inflammation, immune surveillance, and tissue repair. Upon recruitment to tissues, monocytes differentiate into macrophages with diverse phenotypes and functions influenced by local microenvironmental cues. Macrophages, in turn, exhibit a spectrum of activation states ranging from pro-inflammatory (M1) to anti-inflammatory or pro-repair (M2), with implications for various physiological and pathological processes. Recent studies have implicated monocytes and macrophages in the pathogenesis of MPNs. Circulating monocytes in MPN patients display altered functional characteristics, including dysregulated cytokine production and enhanced fibrotic potential. Additionally, monocytosis, an elevated monocyte count, has been identified as an adverse prognostic factor in MPNs, particularly in PMF.

Based on these observations, investigator propose that monocytes and macrophages contribute to the phenotypic expression of MPNs and that distinct phenotypic and functional signatures of these cells may be associated with different MPN subtypes. By leveraging available techniques for genetic and functional analysis, study team aims to elucidate the role of monocytes and macrophages in MPN pathogenesis and identify potential biomarkers associated with disease phenotype and prognosis. Through comprehensive characterization of these immune cell populations, investigator seek to gain insights into the underlying mechanisms driving the heterogeneity of MPNs and identify novel therapeutic targets for precision medicine approaches.

Being tested
Monocytes signatures in myeloproliferative neoplasms at diagnosis
Medical subject headings
Myeloproliferative Disorders, Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monocytes signatures in myeloproliferative neoplasms at diagnosisDiagnostic test

    The monocytes signatures will be perform from a peripheral blood sample. The signature will be derived from (i) surface marker expression, (ii) cytokines profiles, (iii) genes expression.

Study groups in NCT06361641
Study groupRoleWhat they receive
Phemop CohortExperimentalNot described
Receives: Diagnostic Test: Monocytes signatures in myeloproliferative neoplasms at diagnosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis

    Assessment of the monocytic signature against the WHO diagnosis (AUC will be determined)

    Measured: Day 0

Secondary outcomes (7)
  1. Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene).

    The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis

    Measured: 24 months

  2. Identify correlation between the monocytic signature and the grade of fibrosis

    The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis The monocytic signature will be compared between the different stages of fibrosis (WHO definition for fibrosis grading)

    Measured: 24 months

  3. prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6

    Evaluate the prognostic value of the monocytic signature for treatment response

    The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 :

    • Complete response: normal blood counts
    • Partial response: platelets between 400 and 600 G/L
    • No response: absence of complete or partial response

    Measured: 12, 24 months

  4. Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022

    Evaluate the prognostic value of the monocyte signature for disease worsening The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis

    Disease worsening criteria according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022):

    • Worsening is defined by the presence of at least one of the following criteria: i) leukocytosis >12 G/L or presence of immature granulocytes >2% or erythroblasts >1%; (ii) anemia (hemoglobin <12 g/dL in a woman or <13 g/dL in man) not related to treatment toxicity; (iii) thrombocytopenia (platelet count <150G/L) not related to treatment toxicity; (iv) onset of splenomegaly or progression of pre-existing splenomegaly; (v) thrombocytosis despite cytoreductive therapy

    Measured: 24 months

  5. leukemia-free survival

    The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Outcome measure : leukemia-free survival and myelofibrosis-free survival Evaluate the prognostic value of the monocytic signature for hematological progression (acute myeloid leukemia or myelofibrosis)

    Measured: 24 months

  6. myelofibrosis-free survival

    The monocytic signature will be derived from surface marker expression, cytokines profile and genes expression using a principal component analysis Outcome measure : leukemia-free survival and myelofibrosis-free survival Evaluate the prognostic value of the monocytic signature for hematological progression (acute myeloid leukemia or myelofibrosis)

    Measured: 24 months

  7. Monocytes parameters for hematological progression

    Evaluate the prosnostic value of monocytes parameters for hematological progression Hematological free survival wil be evaluated by cox models

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study start29 May 2024
  3. Primary completion29 May 2027 (estimated)
  4. Study completion29 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361641
Sponsor's protocol ID
49RC23_0259
Other IDs
AO2721-44
Acronym
PHEMOP
Status last verified
Dec 2025
First submitted
12 Mar 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Monocytes signatures in myeloproliferative neoplasms at diagnosis in people with Myeloproliferative Neoplasm and Polycythemia Vera, run by University Hospital, Angers at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Agathe GOUBAND, PharmD (02 41 35 55 96 ext. 33, Agathe.Gouband@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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