MATURE B-CELL LYMPHOIDSREFRACT-LyMANCT07385612
Research for Resistance Factors in the Treatment of Lymphoid Hemopathy
An observational study of MATURE B-CELL LYMPHOIDS, run by Nantes University Hospital at 4 sites in France.
Trial summary
In order to promote translational research on the molecular pathways involved in resistance to treatments for mantle cell lymphoma (MCL), the clinical haematology department of the University Hospital Center (CHU) of Nantes has established, since 2016, the REFRACT-LyMa (Research on Factors of Resistance to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MATURE B-CELL LYMPHOIDS
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2026to 1 Jun 2036
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed or relapsed B-NHL patients managed in the hematology departments of Nantes, La Roche-Sur-Yon, Saint-Nazaire and Poitiers.
Who may be able to join
- Patient affected by B-NHL (at diagnosis or relapse).
- Patient who has signed the consent form.
- Patient affiliated with a social security system.
Who cannot join
- Minor patients.
- Adults under guardianship.
- Protected persons.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
CHD Vendée
La Roche-sur-Yon
Antoine Leveque, +33 2.51.44.61.73, Antoine.leveque@ght85.fr
Antoine Leveque
CHU Nantes
Nantes
Benoit TESSOULIN, MD, +33 2 40 08 32 71, benoit.tessoulin@chu-nantes.fr
Benoit TESSOULIN, MD
CHU de Poitiers
Poitiers
Stéphanie Guidez, +33 5.49.44.44.44, stephanie.guidez@chu-poitiers.fr
Stéphanie Guidez
CH de Saint-Nazaire
Saint-Nazaire
Marion Loirat, +33 2.72.27.80.38, m.loirat@ch-saintnazaire.fr
Marion Loirat
About this study
Official title: RESEARCH ON FACTORS OF RESISTANCE TO CHEMOTHERAPY AND INNOVATIVE THERAPIES IN MATURE B-CELL LYMPHOIDS
In order to promote translational research on the molecular pathways involved in resistance to treatments for mantle cell lymphoma (MCL), the clinical haematology department of the University Hospital Center (CHU) of Nantes has established, since 2016, the REFRACT-LyMa (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma) cohort-biocollection of blood and bone marrow samples from patients with MCL. Thanks to the close collaborations with team 11 of the Integrated Cancer Research and Immunology Center Nantes Angers (CRCI²NA), which specializes in studying the molecular pathways involved in resistance to treatments for hematological cancers, we wish to broaden the scope of research to other B-cell non-Hodgkin lymphomas (B-NHL). That is why today the REFRACT-LyMa cohort-biocollection aims to expand to malignant hematopathies involving mature B cells (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies).
Read the detailed description
A collection of tumor samples collected before the initiation of any new line of treatment as well as after any relapse/progression, is essential to identify the factors of response or resistance to a given therapy. To support the translational research projects on MCL in collaboration with team 11 of CRCI²NA, the clinical hematology department of the CHU of Nantes established, in 2016, the prospective multicentric (five centers: Nantes, La Roche-sur-Yon, Vannes, Saint-Nazaire and Poitiers) cohort-biocollection REFRACT-LyMA (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma), with the aim of constituting a cohort of patients integrating clinico-biological data linked to a biocollection of blood, bone marrow, lymphadenopathy, pleural fluid and ascites samples. Thanks to primary cells from patients derived from the biocollection, the REFRACT-LyMa cohort has highlighted molecular aberrations and genomic instability of tumor cells leading to the emergence of heterogeneous subclones at the base of the main mechanism of chemoresistance, which can be used as predictive factors of response/sensitivity to treatments in MCL. However, the therapies used in MCL are also applicable to other malignant hematopathies. That is why we wish to expand our cohort-biocollection to the Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies (REFRACT-LyMa). Although the patients with MCL already included in the cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma" will continue to be followed retrospectively and new MCL patients will be included prospectively, not all new patients with B-NHL will be automatically included in the new cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B Lymphoid Hemopathies". The choice will depend on the pathology subject to the ongoing translational research studies.
- Conditions
- MATURE B-CELL LYMPHOIDS
- Keywords
- B-cell non-Hodgkin lymphoma, treatments resistance, tumor microenvironment, biocollection
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed or relapsed NHL-B patients (based on ongoing translational research studies) | Clinical data collection and blood, bone marrow, lymphadenopathy as well as pleural fluid and ascites sampling at the time of inclusion (for diagnosis or relapse) and at each relapse/progression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the tumor
Characterization of the tumor and its microenvironment in B-NHL in order to develop preclinical models of ex vivo culture and genetic modifications of primary B-NHL cells.
Measured: 10 years
Secondary outcomes (3)
Preclinical model
Development of preclinical models of ex vivo culture to analyze the response to treatment
Measured: 10 years
Preclinical model
Development of genetic modifications of primary B-NHL cells to evaluate resistance mechanisms
Measured: 10 years
Data analysis
Analysis of genomic data to identify resistance genes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2036 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MATURE B-CELL LYMPHOIDSStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385612
- Sponsor's protocol ID
- RC14_0358
- Acronym
- REFRACT-LyMA
- Status last verified
- May 2026
- First submitted
- 21 Jan 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESEARCH ON FACTORS OF RESISTANCE TO CHEMOTHERAPY AND INNOVATIVE THERAPIES IN MATURE B-CELL LYMPHOIDS
- ClinicalTrials.gov ID
- NCT07385612
- Acronym / sponsor ID
- REFRACT-LyMA / RC14_0358
- Conditions
- MATURE B-CELL LYMPHOIDS
- Keywords
- B-cell non-Hodgkin lymphoma, treatments resistance, tumor microenvironment, biocollection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2036 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 4 Feb 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.
In order to promote translational research on the molecular pathways involved in resistance to treatments for mantle cell lymphoma (MCL), the clinical haematology department of the University Hospital Center (CHU) of Nantes has established, since 2016, the REFRACT-LyMa (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma) cohort-biocollection of blood and bone marrow samples from patients with MCL. Thanks to the close collaborations with team 11 of the Integrated Cancer Research and Immunology Center Nantes Angers (CRCI²NA), which specializes in studying the molecular pathways involved in resistance to treatments for hematological cancers, we wish to broaden the scope of research to other B-cell non-Hodgkin lymphomas (B-NHL). That is why today the REFRACT-LyMa cohort-biocollection aims to expand to malignant hematopathies involving mature B cells (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies).
Detailed description
A collection of tumor samples collected before the initiation of any new line of treatment as well as after any relapse/progression, is essential to identify the factors of response or resistance to a given therapy. To support the translational research projects on MCL in collaboration with team 11 of CRCI²NA, the clinical hematology department of the CHU of Nantes established, in 2016, the prospective multicentric (five centers: Nantes, La Roche-sur-Yon, Vannes, Saint-Nazaire and Poitiers) cohort-biocollection REFRACT-LyMA (Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma), with the aim of constituting a cohort of patients integrating clinico-biological data linked to a biocollection of blood, bone marrow, lymphadenopathy, pleural fluid and ascites samples. Thanks to primary cells from patients derived from the biocollection, the REFRACT-LyMa cohort has highlighted molecular aberrations and genomic instability of tumor cells leading to the emergence of heterogeneous subclones at the base of the main mechanism of chemoresistance, which can be used as predictive factors of response/sensitivity to treatments in MCL. However, the therapies used in MCL are also applicable to other malignant hematopathies. That is why we wish to expand our cohort-biocollection to the Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B-Cell Lymphoid Hemopathies (REFRACT-LyMa). Although the patients with MCL already included in the cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mantle Cell Lymphoma" will continue to be followed retrospectively and new MCL patients will be included prospectively, not all new patients with B-NHL will be automatically included in the new cohort "Research on Factors of Resistance to Chemotherapies and Innovative Therapies in Mature B Lymphoid Hemopathies". The choice will depend on the pathology subject to the ongoing translational research studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed or relapsed NHL-B patients (based on ongoing translational research studies) | – | –Clinical data collection and blood, bone marrow, lymphadenopathy as well as pleural fluid and ascites sampling at the time of inclusion (for diagnosis or relapse) and at each relapse/progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed or relapsed B-NHL patients managed in the hematology departments of Nantes, La Roche-Sur-Yon, Saint-Nazaire and Poitiers.
Key inclusion criteria (3 listed)
- Patient affected by B-NHL (at diagnosis or relapse).
- Patient who has signed the consent form.
- Patient affiliated with a social security system.
Key exclusion criteria (3 listed)
- Minor patients.
- Adults under guardianship.
- Protected persons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the tumor
Time frame: 10 years
Characterization of the tumor and its microenvironment in B-NHL in order to develop preclinical models of ex vivo culture and genetic modifications of primary B-NHL cells.
3 secondary outcomes
Preclinical model
Time frame: 10 years
Preclinical model
Time frame: 10 years
Data analysis
Time frame: 10 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 12 Jun 2026.
- Individual participant dataSharing planned: No
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MATURE B-CELL LYMPHOIDS, run by Nantes University Hospital at 4 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 3 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: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Benoit TESSOULIN, MD (+33 2 40 08 32 71, benoit.tessoulin@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the tumor (time frame: 10 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 12 Jun 2026.