Epitopes-LNH01: Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
Study Details
Study Description
Brief 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.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Other: additional biological samples
blood and tissue 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 |
Other: additional biological samples
blood and tissue samples
|
Outcome Measures
Primary Outcome Measures
- presence of Delta-CD20 T cell responses measured by ELISPOT assay [at inclusion]
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
-
First-line treatment with rituximab
-
For Cohort B :
-
Absence of prior treatment with an anti-CD20 antibody
-
Histologically or cytologically and immunophenotypical confirmed
Exclusion Criteria:
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Régional Universitaire de Besançon | Besançon | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- P/2012/157