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

Primary Purpose

Follicular Lymphoma, Mantle Cell Lymphoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Determination of COVID-19 vacciantion efficacy
Sponsored by
Centre Henri Becquerel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Follicular Lymphoma focused on measuring Sars-Cov-2 immunization, Vaccination, Rituximab, Obinutuzumab, Maintenance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post-vaccination immunity

Arm Description

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

Outcomes

Primary Outcome Measures

Determination of COVID-19 vaccination immunity
kinetics of anti-SARS-CoV-2 antibody titer
Determination of COVID-19 vaccination immunity
Rate of post-vaccination IFN gamma production

Secondary Outcome Measures

Relapse of lymphoma
number of relapse of lymphoma
Infections to SARS-Cov-2
number of SARS-Cov-2 infection

Full Information

First Posted
June 4, 2021
Last Updated
December 22, 2022
Sponsor
Centre Henri Becquerel
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1. Study Identification

Unique Protocol Identification Number
NCT04918940
Brief Title
Efficacy of COVID-19 Vaccination in Patientstreated With Anti-CD20 for Follicular Lymphoma or Mantle Cell Lymphoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
June 27, 2022 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Lymphoma, Mantle Cell Lymphoma
Keywords
Sars-Cov-2 immunization, Vaccination, Rituximab, Obinutuzumab, Maintenance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post-vaccination immunity
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Determination of COVID-19 vacciantion efficacy
Intervention Description
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
Primary Outcome Measure Information:
Title
Determination of COVID-19 vaccination immunity
Description
kinetics of anti-SARS-CoV-2 antibody titer
Time Frame
3 months
Title
Determination of COVID-19 vaccination immunity
Description
Rate of post-vaccination IFN gamma production
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relapse of lymphoma
Description
number of relapse of lymphoma
Time Frame
one year
Title
Infections to SARS-Cov-2
Description
number of SARS-Cov-2 infection
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Jardin, MD, PhD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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