NCT02844491终止不适用
Study of T Specific Immune Response Against Delta-CD20 Peptide in Hematological Malignancies B
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- presence of Delta-CD20 T cell responses measured by ELISPOT assay
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
presence of Delta-CD20 T cell responses measured by ELISPOT assay
时间窗: at inclusion
次要结局
未报告次要终点
研究者
研究点 (1)
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