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

Mantle Cell Lymphoma Clinical Trial

— VAXIMAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918940
• Other study ID #: CHB21.03
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

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