Follicular Lymphoma, Mantle Cell Lymphoma
Conditions
Keywords
Sars-Cov-2 immunization, Vaccination, Rituximab, Obinutuzumab, Maintenance
Brief summary
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.
Interventions
BIOLOGICALDetermination 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
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of COVID-19 vaccination immunity | 3 months | kinetics of anti-SARS-CoV-2 antibody titer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse of lymphoma | one year | number of relapse of lymphoma |
| Infections to SARS-Cov-2 | one year | number of SARS-Cov-2 infection |
Countries
France
Outcome results
None listed