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

NCT07852494 | Not Yet Recruiting

• 1 other identifier: 26-PP-11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Myelomonocytic Leukemia

Keywords

CMML; bone marrow macrophages; single-cell RNA sequencing; spectral flow cytometry

Outcome Measures

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.

  at inclusion

Secondary Outcomes (1)

• Functional and immunomodulatory profile of bone marrow macrophages

  at inclusion

Study Arms (2)

CMML patients

EXPERIMENTAL

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

Control group: Age-matched controls undergoing total hip arthroplasty

ACTIVE COMPARATOR

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

Bone marrow and blood samples PROCEDURE

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.

CMML patients

Bone marrow sample PROCEDURE

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.

Control group: Age-matched controls undergoing total hip arthroplasty

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Age ≥ 55 years
• Scheduled surgery for total hip replacement
• No history of haematological malignancy or autoimmune disease
• Signed informed consent
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• INSERM U1065 - Centre Méditerranéen de Médecine Moléculaire (C3M): collaborator

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Valerie Foussat

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel, non-randomized cohorts are enrolled: participants with confirmed CMML and age-matched controls undergoing elective total hip arthroplasty. No therapeutic intervention is assigned; study procedures consist of biological sample collection followed by ex vivo analyses.

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

FR (1)