ClinicalTrials.gg
RecruitingNCT03280888Updated Jun 16, 2026

Relevance of Peripheral Cells in the Pathophysiology of Chronic Myelomonocytic Leukemia (CMML)

An observational study in Chronic Myelomonocytic Leukemia, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

From the registry’s dates

  • Started Nov 2014; still recruiting 12 years later.

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 46 studies in Leukemia, Myelomonocytic, Chronic with a site in France — 7 open to participants now, 11 under way, 1 of them phase 3. Leukemia, Myelomonocytic, Chronic · France.

Started
2014
with 1 other
Observational
5 of 46
3 open now
Primary completion
2027-11
later than 4 of 10 live
Registered
22nd of 46
by date
Lead sponsor
2 of 46
Centre Hospitalier Universitaire de Nice

Among the 46 studies in Leukemia, Myelomonocytic, Chronic with a site in France, this one is one of 2 that started in 2014, is one of 5 observational ones, reaches primary completion later than 4 of the 10 other live ones, and was the 22nd registered.

Leukemia, Myelomonocytic, Chronic

540 studies on the registry are indexed under Leukemia, Myelomonocytic, Chronic; 69 are open to participants now.

Browse Leukemia, Myelomonocytic, Chronic studies →

Open to participants now

7 of the 46 studies in Leukemia, Myelomonocytic, Chronic with a site in France are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 63 Leukemia, Myelomonocytic, Chronic studies recruiting now, 47 (75%) set no upper age limit and 7 (11%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

Chronic Myelomonocytic Leukemia (CMML) is the most frequent of myelodysplastic/myeloproliferative syndromes, as defined by the WHO classification of myeloid malignancies. The median age at diagnosis is around 70 years with a strong male predominance. CMML is a clonal disease of the bone marrow hematopoietic stem cell mainly characterized by persistent monocytosis (>1x109/L) and the presence of immature dysplastic granulocytes in the peripheral blood of CMML patients. Allogeneic stem cell transplantation (ASCT) remains the only curative option in CMML. However, CMML patients are rarely eligible for this kind of therapy, mainly due to their advanced age. The gold standard treatment of CMML thus remains hydroxyurea, which is usually initiated when the disease becomes proliferative, and demethylating agents, which could be efficient in the most aggressive forms of CMML. Nevertheless, the pathogenesis of CMML remains poorly understood and new therapies are urgently needed for patients in treatment failure.

In recent years, a large numbers of gene mutations have been discovered in CMML, none of which are specific of this entity, as they can be encountered with different frequencies in other myeloid neoplasms. These mutated genes encode signaling molecules (NRAS, KRAS, CBL, JAK2, FLT3 and several members of the Notch pathway), epigenetic regulators (TET2, ASXL1, EZH2, IDH1, IDH2,.) and splicing factors (SF3B1, SRSF2, ZRSF2). Mutations in the transcription regulators RUNX1, NPM1 and TP53 have also been reported in CMML. However, the role of these mutations in leukemogenesis is still unclear. CMML is also characterized by defects in monocyte to macrophage differentiation. These defects in monocyte differentiation can be attributed to the presence of immature dysplastic granulocytes that secrete high levels of alpha-defensins HNP1-3 that antagonize the purinergic receptor P2RY6 in CMML patients. These CD14-/CD15+/CD24+ immature granulocytes that belong to the same clone than the leukemic monocytes seem to have immunosuppressive properties ressembling those of the myeloid-derived suppressor cells (MDCS) described in solid tumours. Whether these immature granulocytes contribute to autoimmune manifestations or immunoescape and progression of CMML is a conendrum and remains to be determined.

In this context, the proposed project aims at identifying news insights into the pathophysiology of CMML through a better definition of the phenotype and function of monocytes and immature granulocytes that characterize this pathology.

03

Conditions studied

  • Chronic Myelomonocytic Leukemia
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with chronic myelomonocytic leukemia

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Inclusion criteria

  • Patients newly diagnosed or undergoing treatment in the Clinical Hematology department of the participating establishments

Exclusion criteria

Exclusion Criteria:

  • NA
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Characterization of molecular mechanisms

    Characterization of the molecular mechanisms involved in the lack of differentiation of monocytes originating from patients with CML.

    Time frame: at 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2014 (actual). Primary completion is estimated for Nov 2027, 156 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2017
First posted
Sep 13, 2017
StartActual
Nov 5, 2014
Primary completionEst.
Nov 5, 2027
CompletionEst.
Nov 5, 2028
Last update
Jun 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03280888
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Nov 5, 2014
Primary completion
Nov 5, 2027 (estimated)
Completion
Nov 5, 2028 (estimated)
Last update
Jun 16, 2026

Study contacts

Laurence Legros, PH
Contact
legros.l@chu-nice.fr
+33 (0)4 92 03 58 41

Oversight

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

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