Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia (RIPAL)

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

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.

Study Overview

• Status: Completed
• Conditions: LYMPHOMA
• Intervention / Treatment: Biological: blood samplings

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®

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with lymphoma or chronic lymphocytic leukemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
large B lymphoma cells (group 1); 30 patients with large B lymphoma cells at diagnosis and who will receive an immunochemotherapy treatment patients will have blood samplings	Biological: blood samplings; 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)
indolent B-cell lymphomas (group 2); 30 patients with indolent B-cell lymphomas without invasion excess blood lymphoma 1 giga / L at diagnosis and who will receive an immunochemotherapy treatment- patients will have blood samplings	Biological: blood samplings; 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)
indolent B-cell lymphomas (group 3); 20 Patients with indolent B-cell lymphomas with lymphocytosis (> 1 Giga / L) at diagnosis and who will receive an immunochemotherapy treatment- patients will have blood samplings	Biological: blood samplings; 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)
Lymphocytic Leukemia Chronic (LLC) (group 4); 20 patients with LLC never treated before and will receive an immunochemotherapy treatment (fludarabine +/- endoxan +/- rituximab or alemtuzumab)- patients will have blood samplings	Biological: blood samplings; 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)
T-cell lymphoma (group 5); 10 Patients with T-cell lymphoma in 1st line therapy and will receive a combination of chemotherapy- patients will have blood samplings	Biological: blood samplings; 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)
follicular lymphoma (group 6); 6 patients with follicular lymphoma in first line or relapsed and will receive a single immunotherapy treatment (rituximab)- patients will have blood samplings	Biological: blood samplings; 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)
Lymphocytic Leukemia Chronic (LLC) (group 7); 6 patients with LLC never treated and will receive a combination of rituximab, fludarabine, endoxan- patients will have blood samplings	Biological: blood samplings; 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)
Lymphocytic Leukemia Chronic (LLC) (group 8); 6 patients with LLC stage A followed for a period of 18 months without treatment- patients will have blood samplings	Biological: blood samplings; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in variations of the T and B cell repertoire in patients with lymphoid blood disease under treatment	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.	from D0 to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
performance of the mapping of the immune repertoire to predict treatment response	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.	from D0 to 18 months
performance of the mapping of the immune repertoire to predict progression free survival	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.	from D0 to progression
performance of the mapping of the immune repertoire to predict the risk of infection	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	from D0 to 18 months
sensitivity of detection of the circulating clones	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	from D0 to 18 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gilles SALLES, MD, Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, France

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: September 15, 2014
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Infection; relapse; survival; Follicular Lymphoma; Chronic Lymphocytic Leukemia; Non-Hodgkin lymphoma; Diffuse Large B Cell Lymphoma; T Cell Lymphoma; MALT Lymphoma; treatment response; Immune Repertoire; VJ rearrangement
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: 2009.548; 2010-A00591-38 (Other Identifier: ANSM)