Non-hodgkin Lymphoma,B CellLYMPHO-CoVacNCT05050461
Immune Response After SARS-CoV-2 (COVID-19) Vaccination in a Context of Non-Hodgkin Lymphoma
A study testing Immunological analyses in people with Non-hodgkin Lymphoma,B Cell and Vaccination Failure, run by Versailles Hospital at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-hodgkin Lymphoma,B Cell, Vaccination Failure
- What is being tested?
- Immunological analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesFrance
- Study dates
- 15 Nov 2021to 15 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult aged at least 18 years old
- Having received (at least) two injections of anti-SARS-CoV-2 messenger RNA vaccine (Pfizer and / or Moderna)
- Affiliated to social security
- consenting to the study
- Concerning cases only: Be or have been affected by B-NHL in remission, active surveillance or during first-line or second-line treatment, regardless of this treatment
Who cannot join
- Patient less than 18 years old
- Patient with protective measure (curatorship, guardianship, safeguard of justice, deprived of liberty, in an emergency situation)
- Patient unable to express their consent
- Pregnant or breastfeeding woman
- Patient refusing to participate
- Concerning cases: Patient whose life expectancy related to B-NHL is less than 6 months, History of allogeneic hematopoietic stem cell transplantation, Patient with CART cells treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
André Mignot -Versailles Hospital, Hemato-oncology unit
Le Chesnay, Île-de-France Region, 78150
Emile Muller Hospital, Hematology unit
Mulhouse, 68100
saint Louis Hospital, Hemato-oncology unit
Paris, Île-de-France Region, 75010
Saint Antoine Hospital, Hematology unit
Paris, Île-de-France Region, 75012
Pitié Salpêtrière Hospital, Hematology unit
Paris, Île-de-France Region, 75013
Institut of Cancerology Strasbourg Europe (ICANS), Hematology deparment
Strasbourg, 67000
Hospitals of Brabois, Hematology unit
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma
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.
Read more
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.
- Conditions
- Non-hodgkin Lymphoma,B Cell, Vaccination Failure
- Being tested
- Immunological analyses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunological analysesOther
Immunological analyses will be performed at inclusion in both arms
| Study group | Role | What they receive |
|---|---|---|
| Cases | Active comparator | Patients with a history of B-NHL Receives: Other: Immunological analyses |
| Controls | Other | Spouses of cases Receives: Other: Immunological analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start15 Nov 2021
- Primary completion28 Feb 2023
- Study completion15 Nov 2023
Why it stopped: Given the evolution of Covid 19, patient inclusions became very difficult or even non-existent in all participating centers over time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-hodgkin Lymphoma,B CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be an arm foses and an arm for controls
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline BESSON, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050461
- Sponsor's protocol ID
- P21/08 - LYMPHO-CoVac
- Acronym
- LYMPHO-CoVac
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33408181Lamure 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.
PubMed 33073216Lamure 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.
PubMed 39902042
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response After SARS-CoV-2 Vaccination in a Context of Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05050461
- Acronym / sponsor ID
- LYMPHO-CoVac / P21/08 - LYMPHO-CoVac
- Conditions
- Non-hodgkin Lymphoma,B Cell, Vaccination Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Given the evolution of Covid 19, patient inclusions became very difficult or even non-existent in all participating centers over time
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be an arm foses and an arm for controls
| Arm | Type | Receives |
|---|---|---|
| Cases | Active comparator | Other: Immunological analysesPatients with a history of B-NHL |
| Controls | Other | Other: Immunological analysesSpouses of cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult aged at least 18 years old
Key exclusion criteria (6 listed)
- Patient less than 18 years old
- Patient with protective measure (curatorship, guardianship, safeguard of justice, deprived of liberty, in an emergency situation)
- Patient unable to express their consent
- Pregnant or breastfeeding woman
- Patient refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunological analysesImmunological analyses will be performed at inclusion in both arms | Other | Cases, Controls |
Primary outcome
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.
Time frame: at inclusion
Results and safety
The study was stopped early (reason given: Given the evolution of Covid 19, patient inclusions became very difficult or even non-existent in all participating centers over time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 33408181Dan 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.
- Background: PubMed 33073216Lamure 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.
- Results publication: PubMed 39902042Lamure 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.
Related trials for Non-hodgkin Lymphoma,B Cell
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
RecruitingPhase 3
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
B-Cell Acute Lymphoblastic Leukaemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunological analyses in people with Non-hodgkin Lymphoma,B Cell and Vaccination Failure, run by Versailles Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Given the evolution of Covid 19, patient inclusions became very difficult or even non-existent in all participating centers over time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05050461, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.