Hematological Malignancies BEpitopes-LNH01NCT02844491
Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
An observational study of Hematological Malignancies B, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematological Malignancies B
- What is being tested?
- additional biological samples
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2013to 19 Sep 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients studied will be carrying a malignant lymphoproliferative B high grade or low grade treated with an anti-CD20 antibody (cohort A) or hematological whatever type not treated with an anti-CD20 antibody ( cohort B).
Who may be able to join
- For all patient :
- •Written informed consent
- For Cohort A :
- Patient with hematological malignancy of high grade phenotype B (non Hodgkin's lymphoma diffuse large cell) or low grade (mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma or Waldenstrom disease), regardless the initial extension stage.
- Histologically or cytologically and immunophenotypical confirmed
- Patient candidate to a second-line or more therapy
Show all 10Show fewer
- First-line treatment with rituximab
- For Cohort B :
- Absence of prior treatment with an anti-CD20 antibody
- Histologically or cytologically and immunophenotypical confirmed
Who cannot join
- For all patients :
- Patient with any medical or psychiatric condition or disease,
- Patient under guardianship, curatorship or under the protection of justice and pregnant women
- For Cohort A :
- Patient with chronic lymphocytic leukemia
- Patient with indolent lymphoma relapsed more than 1 year after treatment with Rituximab
- Patient allogeneic hematopoietic cells
- Patient with linked lymphoproliferative syndrome with congenital immunosuppression (eg SCID, XLP ...) or acquired (post-transplant lymphoma)
Trial locations and contacts
1 site in 1 country.
About this study
Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform.
The investigators group would now determine if it's possible, in patients with lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20 peptides.
If this memory response exists, it will confirm the interest of this antigen as a target for tumor immunotherapy.
- Conditions
- Hematological Malignancies B
- Being tested
- additional biological samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional biological samplesOther
blood and tissue samples
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | In Cohort A, patients will be included either in the group "sustainable response"or in the "short / refractory response" group.
- "sustainable response" group : patient with NHL diffuse large B cells, and persistent complete response for at least 6 months after first-line treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease in complete response or partial stable response for at least 1 year after first line treatment with Rituximab
"short / refractory response" group : patient with NHL diffuse large B cells, refractory or relapsed in less than 6 months after at least one line of treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease refractory or relapsed / progression within less than 1 year after at least one line of treatment with Rituximab Receives: Other: additional biological samples | |
| Cohort B | For Cohort B patients will be included either in the group "B hematologic therapeutic abstention" or in the group "any blood disease not treated with anti-CD20 antibodies."
"B hematologic therapeutic abstention" group : patient with hematological malignancy whatever the initial expansion stage
"any blood disease not treated with anti-CD20 antibodies" group : patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstorm disease without treatment criteria at diagnosis and with stable disease for at least 6 months Receives: Other: additional biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of Delta-CD20 T cell responses measured by ELISPOT assay
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start22 Jan 2013
- Primary completion19 Sep 2014
- Study completion19 Sep 2014
Why it stopped: Difficulty of recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematological Malignancies BStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844491
- Sponsor's protocol ID
- P/2012/157
- Acronym
- Epitopes-LNH01
- Status last verified
- Jan 2021
- First submitted
- 22 Jul 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Vauchy C, Gamonet C, Ferrand C, Daguindau E, Galaine J, Beziaud L, Chauchet A, Henry Dunand CJ, Deschamps M, Rohrlich PS, Borg C, Adotevi O, Godet Y. CD20 alternative splicing isoform generates immunogenic CD4 helper T epitopes. Int J Cancer. 2015 Jul 1;137(1):116-26. doi: 10.1002/ijc.29366. Epub 2014 Dec 12.
PubMed 25449106
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
- ClinicalTrials.gov ID
- NCT02844491
- Acronym / sponsor ID
- Epitopes-LNH01 / P/2012/157
- Conditions
- Hematological Malignancies B
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty of recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 22 Jan 2013 (actual)
- Primary completion
- 19 Sep 2014 (actual)
- Study completion
- 19 Sep 2014 (actual)
- First posted
- 26 Jul 2016 (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.
Cancer-specific splice variants gain significant interest as they generate neo-antigens, that could be targeted by immune cells. CD20, a membrane antigen broadly expressed in mature B cell lymphomas, is subject to an alternative splicing named Delta-CD20 leading to loss of membrane expression of the spliced isoform.
The investigators group would now determine if it's possible, in patients with lymphoproliferative B, to detect the presence of a specific memory response to delta-CD20 peptides.
If this memory response exists, it will confirm the interest of this antigen as a target for tumor immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: additional biological samplesIn Cohort A, patients will be included either in the group "sustainable response"or in the "short / refractory response" group. - "sustainable response" group : patient with NHL diffuse large B cells, and persistent complete response for at least 6 months after first-line treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease in complete response or partial stable response for at least 1 year after first line treatment with Rituximab "short / refractory response" group : patient with NHL diffuse large B cells, refractory or relapsed in less than 6 months after at least one line of treatment with Rituximab OR patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstrom's disease refractory or relapsed / progression within less than 1 year after at least one line of treatment with Rituximab |
| Cohort B | – | Other: additional biological samplesFor Cohort B patients will be included either in the group "B hematologic therapeutic abstention" or in the group "any blood disease not treated with anti-CD20 antibodies." "B hematologic therapeutic abstention" group : patient with hematological malignancy whatever the initial expansion stage "any blood disease not treated with anti-CD20 antibodies" group : patient with follicular NHL, mantle NHL, NHL marginal zone or Waldenstorm disease without treatment criteria at diagnosis and with stable disease for at least 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients studied will be carrying a malignant lymphoproliferative B high grade or low grade treated with an anti-CD20 antibody (cohort A) or hematological whatever type not treated with an anti-CD20 antibody ( cohort B).
Key inclusion criteria (10 listed)
- For all patient :
- •Written informed consent
- For Cohort A :
- For Cohort B :
Key exclusion criteria (8 listed)
- For all patients :
- For Cohort A :
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 |
|---|---|---|
| additional biological samplesblood and tissue samples | Other | Cohort A, Cohort B |
Primary outcome
presence of Delta-CD20 T cell responses measured by ELISPOT assay
Time frame: at inclusion
Results and safety
The study was stopped early (reason given: Difficulty of recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 25449106Vauchy C, Gamonet C, Ferrand C, Daguindau E, Galaine J, Beziaud L, Chauchet A, Henry Dunand CJ, Deschamps M, Rohrlich PS, Borg C, Adotevi O, Godet Y. CD20 alternative splicing isoform generates immunogenic CD4 helper T epitopes. Int J Cancer. 2015 Jul 1;137(1):116-26. doi: 10.1002/ijc.29366. Epub 2014 Dec 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hematological Malignancies B, run by Centre Hospitalier Universitaire de Besancon 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 10 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Feb 2021. 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 was stopped early (reason given: Difficulty of recruiting). Results are not available in the source record.
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?
presence of Delta-CD20 T cell responses measured by ELISPOT assay (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02844491, which also lists 1 linked publication.
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 2 Feb 2021.