Leukemia, Lymphoblastic, Acute, PediatricREALL CD9NCT06649253
Childhood B-acute Lymphoblastic Leukaemia and Role of CD9 Gene Regulation in Relapse
A study testing Sampling bone tissue and blood in people with Leukemia, Lymphoblastic, Acute, Pediatric, run by Rennes University Hospital at 3 sites in France.
Trial summary
B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing. CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Leukemia, Lymphoblastic, Acute, Pediatric
- What is being tested?
- Sampling bone tissue and blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Mar 2025to Apr 2035
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Under 18 years
- With established diagnosis of B-ALL
- Initial diagnosis made in the investigating centre
- Having received oral and written information about the protocol, or oral only if the patient is unable to read.
- Having signed a consent form if the patient is capable of giving informed written consent.
- Whose legal guardians have received oral and written information about the protocol, and have signed a free, informed and written consent.
- Beneficiary of a social security scheme
Who cannot join
- Isolated extramedullary involvement at inclusion
- Patient of childbearing age without effective contraception.
- Adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
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
- Recruiting
CHU Angers
Angers
Isabelle PELLIER, pr, 241353637 ext. +33, ispellier@chu-angers.fr
Isabelle PELLIER, Pr
- Recruiting
CHU Brest
Brest
Liana CARAUSU, Pr, 298223333 ext. +33, liana.carausu@chu-brest.fr
Liana CARAUSU, pr
- Recruiting
CHU Rennes
Rennes
Virginie GANDEMER, Pr, 29928254321 ext. +33, virginie.gandemer@chu-rennes.fr
Virginie GANDEMER, Pr
About this study
Official title: REALL CD9 : Molecular Mechanisms Involved in Relapses of Childhood B-acute Lymphoblastic Leukaemia, Role of Non-coding RNA in CD9 Gene Regulation
B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing. CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. The aim of this project is to understand how CD9 regulation can be a marker of potential relapses, using bone and blood sampling of newly diagnosed patients at 3 crucial moments of therapy.
Read the detailed description
B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing despite major therapeutic advances. A research team of the Development and Genetic Institute in Rennes has identified that the expression of CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells, enabling them to persist in niches such as the testis. CD9-associated relapses often arise from these niches. Understanding the regulation of CD9 expression is therefore essential.
The hypothesis on which this project is based is that CD9 expression could be orchestrated by ncRNAs. Due to the complexity of deciphering circRNA-miRNA-mRNA networks, an exploration of patient blasts is envisaged in order to delineate a specific non-coding RNA network regulating CD9 expression from bone marrow and blood samples of paediatric-aged patients with B-ALL. If this hypothesis is confirmed, the ncRNAs identified could constitute new specific diagnostic and prognostic markers, or even therapeutic targets.
To confirm this hypothesis, bone and blood sampling of newly diagnosed patients will be collected at the diagnosis, after first phase of treatment and at the relapse, if it occurs.
- Being tested
- Sampling bone tissue and blood
- Keywords
- CD9, miRNA, gene regulation
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling bone tissue and bloodOther
Extra tube collection of bone and blood will be collected during routine care sampling interventions at the diagnosis, after the first phase of treatment and after relapse, if it occurs.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | All included patients. Bone and blood sampling Receives: Other: Sampling bone tissue and blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non coding RNA network in CD9 regulation
description of the network of lncRNAs (circRNAs/miRNAs) involved in the regulation of CD9 present on the surface of blasts at the time of diagnosis of B-ALL (nature of the lncRNAs, level of expression, etc.)
Measured: 5 years
Secondary outcomes (2)
Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up
Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a follow-up marker in CD9+ pediatric B-ALL.
Measured: 5 years
Non coding RNA network in CD9 regulation as a predictive factor of relapse
Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a predictive marker of relapse in CD9+ pediatric B-ALL.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start22 Mar 2025
- Primary completionApr 2035 (estimated)
- Study completionApr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphoblastic, Acute, PediatricStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie COUSIN, Study chair, University of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649253
- Sponsor's protocol ID
- 35RC23_8885_REALLCD9
- Acronym
- REALL CD9
- Status last verified
- Dec 2025
- First submitted
- 15 Oct 2024
- Last updated
- 2 Jan 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 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REALL CD9 : Molecular Mechanisms Involved in Relapses of Childhood B-acute Lymphoblastic Leukaemia, Role of Non-coding RNA in CD9 Gene Regulation
- ClinicalTrials.gov ID
- NCT06649253
- Acronym / sponsor ID
- REALL CD9 / 35RC23_8885_REALLCD9
- Keywords
- CD9, miRNA, gene regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- Apr 2035 (estimated)
- First posted
- 18 Oct 2024 (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.
B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing. CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. The aim of this project is to understand how CD9 regulation can be a marker of potential relapses, using bone and blood sampling of newly diagnosed patients at 3 crucial moments of therapy.
Detailed description
B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing despite major therapeutic advances. A research team of the Development and Genetic Institute in Rennes has identified that the expression of CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells, enabling them to persist in niches such as the testis. CD9-associated relapses often arise from these niches. Understanding the regulation of CD9 expression is therefore essential.
The hypothesis on which this project is based is that CD9 expression could be orchestrated by ncRNAs. Due to the complexity of deciphering circRNA-miRNA-mRNA networks, an exploration of patient blasts is envisaged in order to delineate a specific non-coding RNA network regulating CD9 expression from bone marrow and blood samples of paediatric-aged patients with B-ALL. If this hypothesis is confirmed, the ncRNAs identified could constitute new specific diagnostic and prognostic markers, or even therapeutic targets.
To confirm this hypothesis, bone and blood sampling of newly diagnosed patients will be collected at the diagnosis, after first phase of treatment and at the relapse, if it occurs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Sampling bone tissue and bloodAll included patients. Bone and blood sampling |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Under 18 years
- With established diagnosis of B-ALL
- Initial diagnosis made in the investigating centre
- Having received oral and written information about the protocol, or oral only if the patient is unable to read.
- Having signed a consent form if the patient is capable of giving informed written consent.
Key exclusion criteria (3 listed)
- Isolated extramedullary involvement at inclusion
- Patient of childbearing age without effective contraception.
- Adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.
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 |
|---|---|---|
| Sampling bone tissue and bloodExtra tube collection of bone and blood will be collected during routine care sampling interventions at the diagnosis, after the first phase of treatment and after relapse, if it occurs. | Other | Patients |
Primary outcome
Non coding RNA network in CD9 regulation
Time frame: 5 years
description of the network of lncRNAs (circRNAs/miRNAs) involved in the regulation of CD9 present on the surface of blasts at the time of diagnosis of B-ALL (nature of the lncRNAs, level of expression, etc.)
2 secondary outcomes
Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up
Time frame: 5 years
Non coding RNA network in CD9 regulation as a predictive factor of relapse
Time frame: 5 years
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 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Elie COUSIN study chair
University of Rennes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling bone tissue and blood in people with Leukemia, Lymphoblastic, Acute, Pediatric, run by Rennes University Hospital 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 7 inclusion and 3 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 2 Jan 2026. 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 Elie COUSIN, Md (299284321 ext. +33, elie.cousin@univ-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non coding RNA network in CD9 regulation (time frame: 5 years). 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 2 Jan 2026.