Skip to main content
OpenTrials
Completed

NCT Number: NCT04918940

Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Determination of COVID-19 vacciantion efficacy

Biological

Samples will be taken after each vaccine injection to perform Sars-Cov-2 serology and Elispot interferon gamma and 3 months after the first vaccine injection

Primary outcomes

  1. Determination of COVID-19 vaccination immunity

    Time frame: 3 months

    kinetics of anti-SARS-CoV-2 antibody titer

  2. Determination of COVID-19 vaccination immunity

    Time frame: 3 months

    Rate of post-vaccination IFN gamma production

Secondary outcomes

  1. Relapse of lymphoma

    Time frame: one year

    number of relapse of lymphoma

  2. Infections to SARS-Cov-2

    Time frame: one year

    number of SARS-Cov-2 infection

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: VAXIMAB

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2021
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.