Acute Lymphoid LeukemiaMILANCT05792007
Study of the Medullary Microenvironment in Acute Childhood Leukemia
A study testing Biological sampling in patients in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia in Children, run by University Hospital, Tours at 3 sites in France.
Trial summary
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and/or progress to death of the child. Read more about this study
- Who is it for?
- Ages 1 year to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Lymphoid Leukemia, Acute Myeloid Leukemia in Children
- What is being tested?
- Biological sampling in patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- 26 Oct 2023to 24 Oct 2028
- 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 1 year to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- for patients with AL:
- Child with acute lymphoblastic or myeloblastic leukemia at diagnosis
- Not having received prior hematological treatment
- Aged 1 to 15 years old
- Whose 2 parents, or the holder of parental authority, have signed a consent enlightened.
- Affiliated patient or beneficiary of a social security scheme.
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- Control group patients:
- Child undergoing orthopedic surgery exposing the bone marrow (osteotomy of the pelvis).
- Aged between 1 and 15 years old.
- Having no pathology of hematological origin.
- Not having received any treatment that could interfere with the functioning of the bone marrow.
- Whose 2 parents or the holder of parental authority have signed a consent enlightened.
- Affiliated patient or beneficiary of a social security scheme.
Who cannot join
- for patients with AL:
- Patient under 1 year old and over 15 years old.
- Contraindication to myelogram.
- Absence of signature of the informed consent by the 2 parents or the holder of parental authority.
- Patients with relapsed acute lymphoblastic or myeloblastic leukemia.
- Having received prior hematological treatments.
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- Parents with physical or mental condition not allowing to understand the informed consent.
- Control group patients
- Patient under 1 year old and over 15 years old.
- Having an underlying haematological pathology.
- Absence of signature of the informed consent by the 2 parents or the holder of parental authority.
- Having received prior hematological treatments.
- Parents with physical or mental condition not allowing to understand informed consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Not yet recruiting
Service d'hématologie biologique-CHRU TOURS
Tours, 37044
Olivier HERAULT, MD-PhD, +33(0)247474721, olivier.herault@univ-tours.fr
Olivier HERAULT, MD-PhD
- Recruiting
Service d'onco-hématologie pédiatrique -CHRU Tours
Tours, 37044
Julien LEJEUNE, MD-PhD, j.lejeune@chu-tours.fr
Julien LEJEUNE, MD-PhD
- Recruiting
Service de chirurgie orthopédique pédiatrique -CHRU TOURS
Tours, 37044
Thierry ODENT, MD-PhD, +33(0)247473822, t.odent@chu-tours.fr
Thierry ODENT, MD-PhD
About this study
Official title: Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.
Read the detailed description
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of AL's relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases. The study of the microenvironment appears in this context as a promising avenue. The bone marrow microenvironment is composed of an extracellular matrix and cells, in particular mesenchymal stromal stem cells (MSC's). In adult acute leukemia, it has been clearly demonstrated that these microenvironment cells are reprogrammed by leukemia cells to allow the development and proliferation of the latter. Links have also been demonstrated in acute leukemia between the cells of the microenvironment and resistance to chemotherapy. In a certain number of cases, the support of the microenvironment for the development of leukemia or resistance to chemotherapy involves modulation of the energy metabolism of leukemia cells. This notably involves interactions between leukemic cells and MSCs and re-programming of the energy metabolism of the latter. To date, there are only very few studies concerning the role of the microenvironment in acute childhood leukemia and none to date has specifically studied the energy metabolism (oxidative phosphorylation and glycolysis) of MSCs.
- Being tested
- Biological sampling in patients, Biological sampling in control patients
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampling in patientsProcedure or surgery
blood and bone marrow samples from patients with Acute Leulemia.
Biological sampling in control patientsProcedure or surgery
blood and bone marrow samples from children undergoing orthopedic surgery exposing the bone marrow.(osteotomy of the pelvis).
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute leukemias | Active comparator | Children with acute lymphoid leukemia B, acute lymphoid leukemia -T or acute myeloid leukemia Receives: Procedure: Biological sampling in patients |
| Control group | Other | Children without blood diseases Receives: Procedure: Biological sampling in control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Consumption Rate
Difference in oxidative phosphorylation measured by OCR (Oxygen Consumption Rate) in pmol/min/nd DNA between the mesenchymal stromal stem cells (MSCs) of children with Acute Leukemia and those of children without blood diseases.
Measured: At inclusion
Secondary outcomes (7)
Difference in Extra Cellular Acidification Rate
Difference in glycolysis, measured by the ECAR (Extra Cellular Acification Rate) in mpH/min/ng DNA between the MSCs of children with AL and those of children without hematological disease.
Measured: At inclusion
Difference in Reactive Oxygen Species
Difference in oxidative metabolism thanks to the measurement of reactive oxygen species (ROS), measured in MIF/isotype, between MSCs of children with AL and those of children without hematological disease
Measured: At inclusion
Difference in doubling time in culture
The difference in doubling time in culture (measured in days) between the MSCs of children with LA and those of children free of hemopathy. At each passage, the number of living and dead MSCs will be counted.
Measured: At inclusion
Difference in Immunophenotypic profile
The difference in immunophenotypic profile (cytometry, immunofluorescence) between MSCs of children with AL and those of children without hematological disease. Use of a panel of monoclonal antibodies directed against various membrane antigens (CD45, CD34, CD14, CD90, CD73, CD105).
Measured: At inclusion
Difference in mutational profiles between MSCs and leukemia cells
Difference in mutational profiles between MSCs and leukemia cells from children with AL. Comparison of mutations acquired by leukemic cells compared to stromal cells by an NGS-type high-throughput sequencing approach.
Measured: At inclusion
Differences in transcriptomic signatures between MSCs and MSC subpopulations
Differences in transcriptomic signatures between MSCs and MSC subpopulations of children with AL and those of children without hematological disease. The RNAs of the MSCs obtained after culture will be extracted then reverse-transcribed into cDNA. The quality control of the extracted RNAs will be carried out on a Bioanalyzer (Agilent). Transcriptome analysis of the MSC pool will be performed by RNA Seq/NGS. Transcriptomic identification of MSC subpopulations will be performed by single-cell RNAseq/NGS.
Measured: At inclusion
Differences in cytokine profiles within the bone marrow
Differences in cytokine profiles in the bone marrow and in the blood, measured in ng/mL, between children with AL and children without hematological disease.ELISA-like assay of IL-3, IL-6, IL-7, IL-8, IL-10, IL-15, TGF-bêta, IFN-gamma
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 posted30 Mar 2023
- Study start26 Oct 2023
- Primary completion25 Oct 2026 (estimated)
- Study completion24 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, interventional monocentric biological study in two parallel and controlled groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HERAULT, MD-PhD, Study director, University Hospital of TOURSJulien LEJEUNE, MD-PhD, Principal investigator, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792007
- Sponsor's protocol ID
- DR220254-MILA
- Other IDs
- 2022-A02570-43
- Acronym
- MILA
- Status last verified
- Nov 2025
- First submitted
- 8 Mar 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant
- ClinicalTrials.gov ID
- NCT05792007
- Acronym / sponsor ID
- MILA / DR220254-MILA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 24 Oct 2028 (estimated)
- First posted
- 30 Mar 2023 (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.
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.
Detailed description
Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of AL's relapse and/or progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases. The study of the microenvironment appears in this context as a promising avenue. The bone marrow microenvironment is composed of an extracellular matrix and cells, in particular mesenchymal stromal stem cells (MSC's). In adult acute leukemia, it has been clearly demonstrated that these microenvironment cells are reprogrammed by leukemia cells to allow the development and proliferation of the latter. Links have also been demonstrated in acute leukemia between the cells of the microenvironment and resistance to chemotherapy. In a certain number of cases, the support of the microenvironment for the development of leukemia or resistance to chemotherapy involves modulation of the energy metabolism of leukemia cells. This notably involves interactions between leukemic cells and MSCs and re-programming of the energy metabolism of the latter. To date, there are only very few studies concerning the role of the microenvironment in acute childhood leukemia and none to date has specifically studied the energy metabolism (oxidative phosphorylation and glycolysis) of MSCs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, interventional monocentric biological study in two parallel and controlled groups
| Arm | Type | Receives |
|---|---|---|
| Patients with acute leukemias | Active comparator | Procedure: Biological sampling in patientsChildren with acute lymphoid leukemia B, acute lymphoid leukemia -T or acute myeloid leukemia |
| Control group | Other | Procedure: Biological sampling in control patientsChildren without blood diseases |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- for patients with AL:
- Control group patients:
Key exclusion criteria (13 listed)
- for patients with AL:
- Control group patients
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 |
|---|---|---|
| Biological sampling in patientsblood and bone marrow samples from patients with Acute Leulemia. | Procedure or surgery | Patients with acute leukemias |
| Biological sampling in control patientsblood and bone marrow samples from children undergoing orthopedic surgery exposing the bone marrow.(osteotomy of the pelvis). | Procedure or surgery | Control group |
Primary outcome
Oxygen Consumption Rate
Time frame: At inclusion
Difference in oxidative phosphorylation measured by OCR (Oxygen Consumption Rate) in pmol/min/nd DNA between the mesenchymal stromal stem cells (MSCs) of children with Acute Leukemia and those of children without blood diseases.
7 secondary outcomes
Difference in Extra Cellular Acidification Rate
Time frame: At inclusion
Difference in Reactive Oxygen Species
Time frame: At inclusion
Difference in doubling time in culture
Time frame: At inclusion
Difference in Immunophenotypic profile
Time frame: At inclusion
Difference in mutational profiles between MSCs and leukemia cells
Time frame: At inclusion
Differences in transcriptomic signatures between MSCs and MSC subpopulations
Time frame: At inclusion
Differences in cytokine profiles within the bone marrow
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Olivier HERAULT, MD-PhD study director
University Hospital of TOURS
Julien LEJEUNE, MD-PhD principal investigator
University Hospital of TOURS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological sampling in patients in people with Acute Lymphoid Leukemia and Acute Myeloid Leukemia in Children, run by University Hospital, Tours at 3 sites 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 13 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Olivier HERAULT, MD-PhD (+33(0)234378902, olivier.herault@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Consumption Rate (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 24 Nov 2025.