LYMPHOMARIPALNCT02520895
Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia
An observational study of LYMPHOMA, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- LYMPHOMA
- What is being tested?
- blood samplings
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lymphoma or chronic lymphocytic leukemia
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: 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.
Read the 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®
- Conditions
- LYMPHOMA
- Being tested
- blood samplings
- Keywords
- Chronic Lymphocytic Leukemia, Non-Hodgkin lymphoma, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, MALT Lymphoma, T Cell Lymphoma, Immune Repertoire, Infection, relapse, survival, treatment response, VJ rearrangement
- Medical subject headings
- Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Marginal Zone, Lymphoma, T-Cell, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingsBiological
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: 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 Receives: Biological: blood samplings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from D0 to 18 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: from D0 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LYMPHOMAStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles SALLES, MD, Principal investigator, Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520895
- Sponsor's protocol ID
- 2009.548
- Other IDs
- 2010-A00591-38
- Acronym
- RIPAL
- Status last verified
- Jul 2015
- First submitted
- 15 Sep 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH
- ClinicalTrials.gov ID
- NCT02520895
- Acronym / sponsor ID
- RIPAL / 2009.548
- Conditions
- LYMPHOMA
- Keywords
- Chronic Lymphocytic Leukemia, Non-Hodgkin lymphoma, Follicular Lymphoma, Diffuse Large B Cell Lymphoma, MALT Lymphoma, T Cell Lymphoma, Immune Repertoire, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| large B lymphoma cells (group 1) | – | Biological: blood samplings30 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) | – | Biological: blood samplings30 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) | – | Biological: blood samplings20 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) | – | Biological: blood samplings20 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) | – | Biological: blood samplings10 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) | – | Biological: blood samplings6 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) | – | Biological: blood samplings6 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) | – | Biological: blood samplings6 patients with LLC stage A followed for a period of 18 months without treatment- patients will have blood samplings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lymphoma or chronic lymphocytic leukemia
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingspatients 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) | Biological | Lymphocytic Leukemia Chronic (LLC) (group 4), Lymphocytic Leukemia Chronic (LLC) (group 7), Lymphocytic Leukemia Chronic (LLC) (group 8), T-cell lymphoma (group 5), follicular lymphoma (group 6), indolent B-cell lymphomas (group 2), indolent B-cell lymphomas (group 3), large B lymphoma cells (group 1) |
Primary outcome
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.
4 secondary outcomes
performance of the mapping of the immune repertoire to predict treatment response
Time frame: from D0 to 18 months
performance of the mapping of the immune repertoire to predict progression free survival
Time frame: from D0 to progression
performance of the mapping of the immune repertoire to predict the risk of infection
Time frame: from D0 to 18 months
sensitivity of detection of the circulating clones
Time frame: from D0 to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles SALLES, MD principal investigator
Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LYMPHOMA, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.