Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma
NCT ID: NCT04918940
Last Updated: 2022-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-21
2022-06-27
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Post-vaccination immunity
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
Determination of COVID-19 vacciantion efficacy
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
Interventions
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Determination of COVID-19 vacciantion efficacy
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Fabrice Jardin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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Other Identifiers
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CHB21.03
Identifier Type: -
Identifier Source: org_study_id