Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia

LYMPHOMA Clinical Trial

— RIPAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520895
• Other study ID #: 2009.548
• Secondary ID: 2010-A00591-38
• Status: Completed
• Phase: N/A
• First received: September 15, 2014
• Last updated: August 7, 2015
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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®

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

Intervention

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)

Locations

Country	Name	City	State
France	Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No