An observational study in LYMPHOMA, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-13.
Sponsored by Hospices Civils de Lyon · Observational
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.
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®
5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 98 is below the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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patients with lymphoma or chronic lymphocytic leukemia
Exclusion Criteria:
30 patients with large B lymphoma cells at diagnosis and who will receive an immunochemotherapy treatment patients will have blood samplings
Biological: blood samplings
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
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
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
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
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
6 patients with LLC never treated and will receive a combination of rituximab, fludarabine, endoxan- patients will have blood samplings
Biological: blood samplings
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)
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.
Time frame: from D0 to 18 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: from D0 to 18 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon