NCT04918940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

June 4, 2021

Last Update Submit

December 22, 2022

Conditions

Follicular LymphomaMantle Cell Lymphoma

Keywords

Sars-Cov-2 immunizationVaccinationRituximabObinutuzumabMaintenance

Outcome Measures

Primary Outcomes (2)

  • Determination of COVID-19 vaccination immunity

    kinetics of anti-SARS-CoV-2 antibody titer

    3 months

  • Determination of COVID-19 vaccination immunity

    Rate of post-vaccination IFN gamma production

    3 months

Secondary Outcomes (2)

  • Relapse of lymphoma

    one year

  • Infections to SARS-Cov-2

    one year

Study Arms (1)

Post-vaccination immunity

EXPERIMENTAL

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

Biological: Determination of COVID-19 vacciantion efficacy

Interventions

Determination of COVID-19 vacciantion efficacyBIOLOGICAL

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

Post-vaccination immunity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Fabrice Jardin, MD, PhD

    Centre Henri Becquerel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 9, 2021

Study Start

May 21, 2021

Primary Completion

June 27, 2022

Study Completion

June 27, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)