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

Terminated

• Conditions: Hematological Malignancies B
• Interventions: Other: additional biological samples

• Registration Number: NCT02844491
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-22
• Primary Completion: 2014-09-19
• Study Completion: 2014-09-19
• Study First Submitted: 2016-07-22
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-26
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	additional biological samples	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
Cohort B	additional biological samples	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

Primary Outcome Measures

Name	Time	Method
presence of Delta-CD20 T cell responses measured by ELISPOT assay	at inclusion

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France