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NCT Number: NCT02520895

Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia

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.

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Key information

Conditions

Lymphoma Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

About this study

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®

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood samplings

Biological

patients will have blood samplings at different time : D0: day of inclusion = day of the first course of chemotherapy or the 1st day of the confirmation of the diagnosis (group 8) M3: 3 months (+/- 1 month) after the start of treatment (except for group 8) M6: 6 months (+/- 1 month) after the start of treatment or after the 1st day of the confirmation of the diagnosis (group 8) M12 : 12 months after the start of treatment (group 6 and 7) M18: 18 months (+/- 1 month) after the start of treatment or after the 1st day of the confirmation of the diagnosis (group 8) R: to relapse if it occurs before 18 months or at the time of first treatment if it occurs before 18 months (group 8)

Primary outcomes

  1. change in variations of the T and B cell repertoire in patients with lymphoid blood disease under treatment

    Time frame: from D0 to 18 months

    results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL®

    The 2 criteria for obtaining the data are the diversity and intensity of the immune repertoire:

    The intensity of the signal corresponds to the frequency of VJ rearrangements detected in the samples. It is expressed in Arbitrary Units.

    The diversity corresponds to the number of different VJ rearrangements detected compared to all theoretical VJ rearrangement. It is expressed in percentage.

Secondary outcomes

  1. performance of the mapping of the immune repertoire to predict treatment response

    Time frame: from D0 to 18 months

    The response to initial treatment will be confronted with the results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL®

    Response to treatment will be assessed by the local treating physician as complete response (CR), unconfirmed complete response (CRu), partial response (PR), stable disease, or progressive disease (PD) in accordance with the International Workshop Standardized Response Criteria for Non-Hodgkin Lymphoma and International Workshop Standardized Response Criteria for Chronic Lymphocytic Leukemia.

  2. performance of the mapping of the immune repertoire to predict progression free survival

    Time frame: from D0 to progression

    the progression free survival will be confronted with the results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL®

    For all groups except group 8 (LLC untreated): the progression free survival is defined as the number of months elapsed between the first day of treatment (D0) and progression For The group 8: the progression free survival is defined as the number of months elapsed between the first day of the consultation (D0) that led to the confirmation of diagnosis and the date of first treatment.

  3. performance of the mapping of the immune repertoire to predict the risk of infection

    Time frame: from D0 to 18 months

    the number of patients with infection will be confronted with the results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL® All presumed or confirmed infections such as isolated febrile events associated or not with an identifiable site of infection and/or germ clearly identified

  4. sensitivity of detection of the circulating clones

    Time frame: from D0 to 18 months

    results given by the technical Immun'IgH® Human and Human ImmunTraCkeR® and score NDL® will be compared with data obtained from conventional immunophenotypic and molecular data.

    The 3 conventional technics are : morphological examination, immunophenotyping, molecular biology by BIOMED2 primers

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH

Acronym: RIPAL

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2015
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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