Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia
RIPAL
2 other identifiers
observational
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedAugust 13, 2015
July 1, 2015
3.1 years
September 15, 2014
August 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
performance of the mapping of the immune repertoire to predict treatment response
from D0 to 18 months
performance of the mapping of the immune repertoire to predict progression free survival
from D0 to progression
performance of the mapping of the immune repertoire to predict the risk of infection
from D0 to 18 months
sensitivity of detection of the circulating clones
from D0 to 18 months
Study Arms (8)
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
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
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
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
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
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
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
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
Interventions
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)
Eligibility Criteria
patients with lymphoma or chronic lymphocytic leukemia
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilles SALLES, MD
Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
August 13, 2015
Study Start
September 1, 2010
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
August 13, 2015
Record last verified: 2015-07