Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B

NCT02844491 | Terminated

• 1 other identifier: P/2012/157
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancies B

Outcome Measures

Primary Outcomes (1)

• presence of Delta-CD20 T cell responses measured by ELISPOT assay

  at inclusion

Study Arms (2)

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

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

Interventions

additional biological samples OTHER

blood and tissue samples

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

Related Publications (1)

• 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.

  PMID: 25449106 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood samples will be realized at inclusion and Peripheral Blood Mononuclear Cells (PBMC) will be collected. * Tumor tissues will be collected if available.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 26, 2016
• Study Start: January 22, 2013
• Primary Completion: September 19, 2014
• Study Completion: September 19, 2014
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

FR (1)