Chronic Myelomonocytic LeukemiaMAC-AGENCT07852494
Phenotypic and Functional Characterization of Bone Marrow Macrophages in Chronic Myelomonocytic Leukemia
A study testing Bone marrow and blood samples and Bone marrow sample in people with Chronic Myelomonocytic Leukemia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Chronic Myelomonocytic Leukemia
- What is being tested?
- Bone marrow and blood samples and Bone marrow sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 1 Jan 2030
- Phase
- Interventional
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phenotypic and Functional Characterization of Bone Marrow Macrophages in Chronic Myelomonocytic Leukemia (CMML): Comparative Study With Age-Matched Healthy Controls
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
- Being tested
- Bone marrow and blood samples, Bone marrow sample
- Keywords
- CMML, bone marrow macrophages, single-cell RNA sequencing, spectral flow cytometry
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow and blood samplesProcedure or surgery
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.
Bone marrow sampleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Bone marrow sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1065 - Centre Méditerranéen de Médecine Moléculaire (C3M)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852494
- Sponsor's protocol ID
- 26-PP-11
- Acronym
- MAC-AGE
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided