Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B (Epitopes-LNH01)

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 Overview

• Status: Terminated
• Conditions: Hematological Malignancies B
• Intervention / Treatment: Other: additional biological samples

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• France
  • Besançon, France
    • Centre Hospitalier Régional Universitaire de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
presence of Delta-CD20 T cell responses measured by ELISPOT assay	at inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2013
• Primary Completion (Actual): September 19, 2014
• Study Completion (Actual): September 19, 2014

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: P/2012/157