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Given the evolution of Covid 19, patient inclusions became very difficult or even non-existent in all participating centers over time
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The specific immune response to SARS-CoV-2 includes a humoral response - specific IgM appearing 5 days after the onset of symptoms while IgG appears after 14 days - and a T lymphocyte component, with specific activated CD8 and CD4 T lymphocytes.
Mortality from infection varies greatly depending on the age of the affected subjects and their comorbidities including a history of cancer. Among these cancers, a history of malignant hemopathy in the 5 years preceding the onset of Covid-19 increases the risk of death by a factor of 3. Among them, lymphoid hemopathies induce hypogammaglobulinemia and / or lymphopenia. These factors combined with chemotherapy and immunotherapy treatments promote the development of infections in affected individuals. Among these, are the anti-CD20 monoclonal antibodies, widely prescribed for treating B-cell non-Hodgkin lymphomas (B-NHL). They induce a deep and lasting B-cell lymphopenia, which can promote infections. They reduce the production of antibodies and the constitution of memory responses to a new pathogen or to a vaccination. In addition, B lymphocytes likely have a key immunomodulatory role in the control of viral infections.
A retrospective study in 89 patients with lymphoma and Covid-19 were conducted after the first phase of the epidemic in different centers in the Île-de-France and eastern France regions. With a 6-month follow-up, a pejorative prognostic impact of anti-CD20 monoclonal antibody treatment on Covid-19-related mortality were showed.
Vaccination of these at-risk patients is therefore essential. A growing concern is how patients with B-NHL who have been vaccinated with a SARS-CoV-2 mRNA vaccine are protected against infection, depending on whether or not they have received anti-CD20 monoclonal drugs and / or chemotherapy.
Knowing the medium-term immunological evolution after vaccination against SARS-CoV-2 in patients with B-cell NHL is necessary in order to be able to adapt the therapeutic and vaccine recommendations.
The main objective of this study is to determine how recent treatment (in the year before vaccination) with anti-CD20 monoclonal antibody modifies the immune response after vaccination against SARS-CoV-2 in adults with B-NHL compared to patients who have not recently been exposed to this immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Active Comparator | Patients with a history of B-NHL |
|
| Controls | Other | Spouses of cases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunological analyses | Other | Immunological analyses will be performed at inclusion in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of humoral (especially anti-SARS-CoV-2 antibody levels) and T cell memory responses in adult patients with B-NHL depending on whether or not they were exposed to anti-CD20 monoclonal antibody treatment in the year before vaccination. | at inclusion |
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Inclusion Criteria:
Adult aged at least 18 years old
Exclusion Criteria:
Patient less than 18 years old
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emile Muller Hospital, Hematology unit | Mulhouse | 68100 | France | |||
| Institut of Cancerology Strasbourg Europe (ICANS), Hematology deparment |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408181 | Background | Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6. | |
| 33073216 |
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There will be an arm foses and an arm for controls
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| Strasbourg |
| 67000 |
| France |
| Hospitals of Brabois, Hematology unit | Vandœuvre-lès-Nancy | 54500 | France |
| André Mignot -Versailles Hospital, Hemato-oncology unit | Le Chesnay | Île-de-France Region | 78150 | France |
| saint Louis Hospital, Hemato-oncology unit | Paris | Île-de-France Region | 75010 | France |
| Saint Antoine Hospital, Hematology unit | Paris | Île-de-France Region | 75012 | France |
| Pitié Salpêtrière Hospital, Hematology unit | Paris | Île-de-France Region | 75013 | France |
| Background |
| Lamure S, Dulery R, Di Blasi R, Chauchet A, Laureana C, Deau-Fischer B, Drenou B, Soussain C, Rossi C, Noel N, Choquet S, Bologna S, Joly B, Kohn M, Malak S, Fouquet G, Daguindau E, Bernard S, Thieblemont C, Cartron G, Lacombe K, Besson C. Determinants of outcome in Covid-19 hospitalized patients with lymphoma: A retrospective multicentric cohort study. EClinicalMedicine. 2020 Oct;27:100549. doi: 10.1016/j.eclinm.2020.100549. Epub 2020 Oct 13. |
| 39902042 | Result | Lamure S, Chavez HH, de Goer de Herve MG, Fornecker LM, Drenou B, Jacquet C, Merabet F, Kohn M, Quelin F, Jackson A, Choquet S, Dulery R, Taoufik Y, Besson C. Lymphoma patients treated with anti-CD20 and chemotherapy display disconnected T and B cell responses to COVID-19 vaccine. Front Immunol. 2025 Jan 20;15:1524813. doi: 10.3389/fimmu.2024.1524813. eCollection 2024. |