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
- 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 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
Show all 21Show fewer
- 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.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Functional Characterization of Bone Marrow Macrophages in Chronic Myelomonocytic Leukemia (CMML): Comparative Study With Age-Matched Healthy Controls
- ClinicalTrials.gov ID
- NCT07852494
- Acronym / sponsor ID
- MAC-AGE / 26-PP-11
- Conditions
- Chronic Myelomonocytic Leukemia
- Keywords
- CMML, bone marrow macrophages, single-cell RNA sequencing, spectral flow cytometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Collaborators
- INSERM U1065 - Centre Méditerranéen de Médecine Moléculaire (C3M)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CMML patients | Experimental | Procedure: Bone marrow and blood samples2 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 | Active comparator | Procedure: Bone marrow sample2 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow and blood samples2 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 or surgery | CMML patients |
| Bone marrow sample2 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 or surgery | Control group: Age-matched controls undergoing total hip arthroplasty |
Primary outcome
Phenotypic and transcriptional differences in bone marrow macrophages between CMML patients and age-matched controls
Time frame: at inclusion
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.
1 secondary outcome
Functional and immunomodulatory profile of bone marrow macrophages
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Myelomonocytic Leukemia
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia
Atypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia
RecruitingPhase 1
Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers
AML, Multiple Myeloma
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 21 inclusion and 0 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: opening soon, as of the sponsor's last update on 1 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 1 site 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 Valerie Foussat (+33 (0)4 92 03 63 77, foussat.v@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypic and transcriptional differences in bone marrow macrophages between CMML patients and age-matched controls (time frame: at inclusion). 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 1 Oct 2026.