Clinical trial NCT02844491: Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
Official title: Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hematological Malignancies B
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

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.


Eligibility 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)

Primary outcomes:
measure: presence of Delta-CD20 T cell responses measured by ELISPOT assay
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire de Besançon
Study officials:
References:
citation: 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.