Clinical trial NCT02520895: Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia
Official title: Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: LYMPHOMA
Keywords: Chronic Lymphocytic Leukemia
Non-Hodgkin lymphoma
Follicular Lymphoma
Diffuse Large B Cell Lymphoma
MALT Lymphoma
T Cell Lymphoma
Immune Repertoire
Infection
relapse
survival
treatment response
VJ rearrangement
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with lymphoma or chronic lymphocytic leukemia

Brief summary: RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.

Detailed description: Constitution of a prospective cohort of 128 patients with 8 different groups of patients. This protocol is designed to evaluate a new tool for detecting the diversity of the repertoire T and B in patients with hematological disease. This in vitro diagnostic device is consisting of molecular biology kits Human ImmunTraCkeR® and Human Immun'IgH® and the analysis tool NDL®

Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* Subjects with a diagnosis of large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, MALT, marginal zone, Waldenstrom's disease, chronic lymphocytic leukemia, T-cell lymphoma, anaplastic, cytotoxic or peripheral unspecified angioimmunoblastic.
* Have signed an informed consent for participation in the study and preservation of blood samples for biomedical research.
* Accept to appear in consultation biological samples at the sampling points corresponding to its group.
* The benefits of social security.

Exclusion Criteria:

* Subjects with a diagnosis of Hodgkin disease
* Subjects with a diagnosis of T-prolymphocytic leukemia
* Subjects with a diagnosis of Burkitt's lymphoma
* Subjects with a diagnosis of lymphoblastic lymphoma
* Subjects who had prior-treatment for hematological disease
* Patients under judicial safeguards

Primary outcomes:
measure: change in variations of the T and B cell repertoire in patients with lymphoid blood disease under treatment
timeFrame: from D0 to 18 months
Secondary outcomes:
measure: performance of the mapping of the immune repertoire to predict treatment response
timeFrame: from D0 to 18 months
measure: performance of the mapping of the immune repertoire to predict progression free survival
timeFrame: from D0 to progression
measure: performance of the mapping of the immune repertoire to predict the risk of infection
timeFrame: from D0 to 18 months
measure: sensitivity of detection of the circulating clones
timeFrame: from D0 to 18 months
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud
Study officials:
affiliation: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, France
name: Gilles SALLES, MD
role: PRINCIPAL_INVESTIGATOR
References: