Lymphoma, FollicularMOLyFNCT06608147
MOLyF : Bone Marrow and Follicular Lymphoma
A study testing Sampling in people with Lymphoma, Follicular, run by Rennes University Hospital at 1 site in France.
Trial summary
This is a prospective single-center study designed to assess potential differences in cell composition between bone marrows of patients with follicular lymphoma and those from control subjects. Follicular lymphoma is the most common indolent lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2024to 1 Oct 2034
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Major patient
- Patient hospitalized in the thoracic, cardiac and vascular surgery department for surgery involving a sternotomy
- Patient with free, informed, written consent
- Patient covered by a health insurance scheme
Who cannot join
- History of haematological malignancy or haemogram disturbance
- Immunomodulating treatment: immunosuppressants, corticoids, antineoplastics
- Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.)].
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes, 35009
Juliette Ferrant, MD, 0299282555 ext. +33, juliette.ferrant@chu-rennes.fr
Juliette Ferrant, MD
About this study
Official title: Bone Marrow and Follicular Lymphoma
This is a prospective single-center study designed to assess potential differences in cell composition between bone marrows of patients with follicular lymphoma and those from control subjects.
Follicular lymphoma is the most common indolent lymphoma. It is characterised by systematic relapses and bone marrow dissemination in 70% of patients at the time of diagnosis.
Read more
Although relapses are thought to be related to refractory tumour cells nested in a supportive microenvironment in the bone marrow, the mechanisms involved are poorly understood.
To study the specificities of the bone marrow of patients with follicular lymphoma, It is necessary to compare them with control samples.
This study takes advantage of surgeries involving sternotomies to recover lost bone marrow and establish a bone marrow bank of patients without hematological disease.
This bank will be used to set up control cohorts for other clinical trials involving patients with follicular lymphoma.
- Conditions
- Lymphoma, Follicular
- Being tested
- Sampling
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
sternal bone marrow aspiration
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow cytometric quantification of cell populations
Bone marrow cell populations of lymphoma-free patients (lymphoid cells, myeloid cells, stromal cells and adventitial cells) will be quantified using a flow cytometry panel and compared with those of Follicular Lymphoma patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start4 Dec 2024
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliette Ferrant, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608147
- Sponsor's protocol ID
- 35RC24_9716_MOLyF
- Acronym
- MOLyF
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2024
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow and Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT06608147
- Acronym / sponsor ID
- MOLyF / 35RC24_9716_MOLyF
- Conditions
- Lymphoma, Follicular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 23 Sep 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.
This is a prospective single-center study designed to assess potential differences in cell composition between bone marrows of patients with follicular lymphoma and those from control subjects.
Follicular lymphoma is the most common indolent lymphoma. It is characterised by systematic relapses and bone marrow dissemination in 70% of patients at the time of diagnosis.
Although relapses are thought to be related to refractory tumour cells nested in a supportive microenvironment in the bone marrow, the mechanisms involved are poorly understood.
To study the specificities of the bone marrow of patients with follicular lymphoma, It is necessary to compare them with control samples.
This study takes advantage of surgeries involving sternotomies to recover lost bone marrow and establish a bone marrow bank of patients without hematological disease.
This bank will be used to set up control cohorts for other clinical trials involving patients with follicular lymphoma.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient
- Patient hospitalized in the thoracic, cardiac and vascular surgery department for surgery involving a sternotomy
- Patient with free, informed, written consent
- Patient covered by a health insurance scheme
Key exclusion criteria (3 listed)
- History of haematological malignancy or haemogram disturbance
- Immunomodulating treatment: immunosuppressants, corticoids, antineoplastics
- Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.)].
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 |
|---|---|---|
| Samplingsternal bone marrow aspiration | Other | Experimental |
Primary outcome
Flow cytometric quantification of cell populations
Time frame: 1 day
Bone marrow cell populations of lymphoma-free patients (lymphoid cells, myeloid cells, stromal cells and adventitial cells) will be quantified using a flow cytometry panel and compared with those of Follicular Lymphoma patients.
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 10 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphoma, Follicular
Active, not recruitingObservational study
Deucravacitinib for Patients With Moderate/Severe Psoriasis: A Real-Life Experience in Italy
Psoriasis
Not yet recruitingPhase 2
Randomized Phase 2 Study Of Epcoritamab Vs Watch And Wait InPatients With Previously Untreated Low Tumor Burden FollicularLymphoma
Randomized, Phase 2
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
RecruitingPhase 1
A Study of ARC-02 in B-cell NHL
B-cell Non Hodgkin Lymphoma
RecruitingPhase 4
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Preeclampsia, Preeclampsia Postpartum
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.
Juliette Ferrant, MD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling in people with Lymphoma, Follicular, run by Rennes University Hospital 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 4 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 10 Dec 2024. 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 Juliette Ferrant, MD (0299282555 ext. +33, juliette.ferrant@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow cytometric quantification of cell populations (time frame: 1 day). 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 10 Dec 2024.