跳至主要内容
临床试验/NCT04918940
NCT04918940已完成不适用

Post-vaccination Immunization Against SARS-CoV-2 in Patients Undergoing Maintenance With Anti-CD20 Antibodies for Follicular Lymphoma (FL) or Mantle Cell

Centre Henri Becquerel1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Determination of COVID-19 vaccination immunity

研究概览

简要总结

The anti-CD20 monoclonal antibodies, rituximab (R) and obinutuzumab (G), are used as standard maintenance therapy every 2 months for 2 to 3 years in patients with follicular lymphoma (FL) or mantle cell lymphoma (MCL).

This treatment is associated with profound and prolonged B lymphopenia, hypogammaglobulinemia and increased infections. Severe forms of COVID-19 on Rituximab with prolonged carriage of the virus have been reported due to significant impairment of humoral immunity in this context of maintenance therapy.

Therefore, during the COVID-19 epidemic, clinicians are faced with the question of whether to discontinue maintenance therapy or continue treatment. However, the half-life of rituximab is 29 days and lymphopenia continues for up to 9-12 months after stopping injections. Therefore, it is not clear that discontinuation of maintenance therapy will alter the risk of severe SARS-CoV-2.

However, post-vaccination immunization against SARS-CoV-2 by an mRNA vaccine is not known in this context of prolonged treatment with rituximab or obinutuzumab. It is however well established that post-vaccination responses against diphtheria, tetanus, pneumococcus, HBV, or influenza in particular are altered after anti-CD20 antibodies. If the humoral response is crucial in the post-vaccination response, it is also suggested that the preservation of innate immunity and the CD8 response, unaltered by anti-CD20, could also play an important role in the post-vaccination response and virus clearance.

The aim of our study is to evaluate the humoral and post-vaccination T-cell response based on serological data and T-cell production of interferon gamma in response to SARS-CoV-2 specific antigens (Elispot interferon gamma) in this group of patients treated for lymphoma with a long-term anti-CD20 antibody.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age superior to 18 years old
  • Patient undergoing maintenance treatment for Mantle Cell Lymphoma or Follicular Lymphoma treated with rituximab or obinutuzumab in complete remission or stable disease between injection #1 and injection #13 or 19 (end of second year or third year)
  • Inform consent signed

排除标准

  • Documented history of SARS-Cov-2 infection less than 3 months old
  • Progressive lymphoma
  • Contraindication SARS-Cov-2 vaccination (allergy)
  • Refusal of SARS-CoV-2 vaccination
  • Patient who has been off rituximab or obinutuzumab therapy for more than 6 months
  • Patient not covered by health system
  • Pregnant or nursing woman

结局指标

主要结局

Determination of COVID-19 vaccination immunity

时间窗: 3 months

kinetics of anti-SARS-CoV-2 antibody titer

次要结局

  • Infections to SARS-Cov-2(one year)
  • Relapse of lymphoma(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验