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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04918940
Other study ID # CHB21.03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2021
Est. completion date June 27, 2022

Study information

Verified date December 2022
Source Centre Henri Becquerel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 27, 2022
Est. primary completion date June 27, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
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

Locations

Country Name City State
France Centre Henri Becquerel Rouen

Sponsors (1)

Lead Sponsor Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of COVID-19 vaccination immunity kinetics of anti-SARS-CoV-2 antibody titer 3 months
Primary Determination of COVID-19 vaccination immunity Rate of post-vaccination IFN gamma production 3 months
Secondary Relapse of lymphoma number of relapse of lymphoma one year
Secondary Infections to SARS-Cov-2 number of SARS-Cov-2 infection one year
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