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Not yet recruiting NCT07385612

Research for Resistance Factors in the Treatment of Lymphoid Hemopathy

Observational MATURE B-CELL LYMPHOIDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: MATURE B-CELL LYMPHOIDS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

RESEARCH ON FACTORS OF RESISTANCE TO CHEMOTHERAPY AND INNOVATIVE THERAPIES IN MATURE B-CELL LYMPHOIDS

Overview

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.

Primary outcome measures

  • Characterization of the tumor [Time frame: 10 years]
Secondary outcome measures (3)
  • Preclinical model [Time frame: 10 years]
  • Preclinical model [Time frame: 10 years]
  • Data analysis [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • CHD Vendée — La Roche-sur-Yon
  • CHU Nantes — Nantes
  • CHU de Poitiers — Poitiers
  • CH de Saint-Nazaire — Saint-Nazaire

Identifiers

NCT: NCT07385612 · RC14_0358

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗