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Spots Global Cancer Trial Database for Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma

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Trial Identification

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

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

Study ID: NCT04918940

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Henri Becquerel, Rouen, , France

Contact Details

Name: Fabrice Jardin, MD, PhD

Affiliation: Centre Henri Becquerel

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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