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Not yet recruitingNCT07852494MAC-AGEUpdated Oct 1, 2026

Phenotypic and Functional Characterization of Bone Marrow Macrophages in Chronic Myelomonocytic Leukemia

An interventional study of Bone marrow and blood samples and Bone marrow sample in Chronic Myelomonocytic Leukemia, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 1 site in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science

Updated Oct 1, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
01

Study summary

MAC-AGE is a single-center study designed to characterize bone marrow macrophages in patients with chronic myelomonocytic leukemia (CMML) and to compare them with macrophages from age-matched controls undergoing elective total hip arthroplasty. Phenotypic, transcriptional and functional analyses will be performed using spectral/multiparametric flow cytometry, single-cell RNA sequencing and ex vivo functional assays. The study aims to identify CMML-associated macrophage alterations and potential therapeutic targets within the bone marrow immune microenvironment.

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Conditions studied

  • Chronic Myelomonocytic Leukemia

Keywords

  • CMML
  • bone marrow macrophages
  • single-cell RNA sequencing
  • spectral flow cytometry
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In context

Leukemia, Myelomonocytic, Chronic

329 studies on the registry are indexed under Leukemia, Myelomonocytic, Chronic; 67 are open to participants now.

This study's planned enrollment of 120 is above the median of 42 across 297 interventional studies indexed under Leukemia, Myelomonocytic, Chronic.

Browse Leukemia, Myelomonocytic, Chronic studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria - Group Patients with CML

  • Age ≥ 55 years
  • Confirmed diagnosis of chronic myelomonocytic leukaemia (CML) according to WHO criteria (2022 edition)
  • Patient registered with or covered by a social security scheme
  • Bone marrow sample can be obtained during a scheduled consultation
  • Signed informed consent Exclusion criteria - Group 1
  • Active infection or acute inflammatory condition
  • Treatment with chemotherapy or immunosuppressants within the 4 weeks prior to the procedure
  • Medical contraindication to bone marrow aspiration
  • Person under guardianship, curatorship or legal protection
  • Secondary CMML

Inclusion criteria - Group Age-matched healthy controls

  • Age ≥ 55 years
  • Scheduled surgery for total hip replacement
  • No history of haematological malignancy or autoimmune disease
  • Signed informed consent
  • Patient registered with or covered by a social security scheme Exclusion criteria - Group 2
  • Active or uncontrolled chronic inflammatory condition
  • Autoimmune disease
  • Presence of a known haematological disorder, persistent monocytosis or an unexplained haematological abnormality
  • Chronic immunomodulatory or anti-inflammatory treatment
  • History of immunosuppression or chronic inflammatory disease
  • Persons under guardianship, curatorship or judicial protection
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    CMML patients

    2 mL of additional bone marrow are collected during a planned standard-of-care sternal or iliac aspiration, together with 40 mL of additional peripheral blood during routine blood sampling.

    Procedure: Bone marrow and blood samples

  • Active comparator
    Control group: Age-matched controls undergoing total hip arthroplasty

    2 mL of bone marrow are collected from the proximal femoral metaphysis during elective total hip arthroplasty after femoral neck osteotomy, without any additional invasive procedure

    Procedure: Bone marrow sample

Interventions

  • ProcedureBone marrow and blood samples

    2 mL of additional bone marrow are collected during a planned standard-of-care sternal or iliac aspiration, together with 40 mL of additional peripheral blood during routine blood sampling.

  • ProcedureBone marrow sample

    2 mL of additional bone marrow are collected during a planned standard-of-care sternal or iliac aspiration, together with 40 mL of additional peripheral blood during routine blood sampling.

06

What researchers measure

Primary outcomes

  1. Phenotypic and transcriptional differences in bone marrow macrophages between CMML patients and age-matched controls

    Bone marrow macrophages will be characterized by spectral/multiparametric flow cytometry, including CD80, CD86, HLA-DR, CD163, CD206, CD209, CD200R, SIRPα and MARCO, and by targeted RT-qPCR and/or exploratory single-cell RNA sequencing. Differential macrophage populations and gene-expression programs will be compared between the two groups.

    Time frame: at inclusion

Secondary outcomes

  1. Functional and immunomodulatory profile of bone marrow macrophages

    Ex vivo cytokine secretion (including TNF-α, IL-10, CCL2 and TGF-β), phagocytosis of apoptotic or leukemic targets, modulation of naïve CD4+ T-cell polarization (Th1 versus Th2), and response to experimental pharmacological modulators targeting non-canonical caspase-8 and cathepsin B will be assessed and compared between groups

    Time frame: at inclusion

07

Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
    • Thomas Cluzeau, MD PhD · Contact · +33 (0)492039025
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07852494
Lead sponsor
Centre Hospitalier Universitaire de Nice
Collaborators
INSERM U1065 - Centre Méditerranéen de Médecine Moléculaire (C3M)
Responsible party
Sponsor
First posted
Oct 1, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2029 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Oct 1, 2026

Study contacts

Valerie Foussat
Contact
foussat.v@chu-nice.fr
+33 (0)4 92 03 63 77

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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