Research for Resistance Factors in the Treatment of Lymphoid Hemopathy (REFRACT-LyMA)

June 11, 2026 updated by: Nantes University Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • La Roche-sur-Yon, France
        • CHD Vendée
        • Contact:
        • Principal Investigator:
          • Antoine Leveque
      • Nantes, France
        • CHU Nantes
        • Principal Investigator:
          • Benoit TESSOULIN, MD
        • Contact:
      • Poitiers, France
      • Saint-Nazaire, France
        • CH de Saint-Nazaire
        • Contact:
        • Principal Investigator:
          • Marion Loirat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed or relapsed B-NHL patients managed in the hematology departments of Nantes, La Roche-Sur-Yon, Saint-Nazaire and Poitiers.

Description

Inclusion Criteria:

  • Patient affected by B-NHL (at diagnosis or relapse).
  • Patient who has signed the consent form.
  • Patient affiliated with a social security system.

Exclusion Criteria:

  • Minor patients.
  • Adults under guardianship.
  • Protected persons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Preclinical model
Time Frame: 10 years
Development of preclinical models of ex vivo culture to analyze the response to treatment
10 years
Preclinical model
Time Frame: 10 years
Development of genetic modifications of primary B-NHL cells to evaluate resistance mechanisms
10 years
Data analysis
Time Frame: 10 years
Analysis of genomic data to identify resistance genes
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC14_0358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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