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

Hematological Malignancies B Clinical Trial

— Epitopes-LNH01  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02844491
• Other study ID #: P/2012/157
• Status: Terminated
• Start date: January 22, 2013
• Est. completion date: September 19, 2014

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 19, 2014
• Est. primary completion date: September 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies B
• Neoplasms

Intervention

Other:
• additional biological samples
blood and tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of Delta-CD20 T cell responses measured by ELISPOT assay		at inclusion