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Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma (LYMPHO-Cov-2)

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ClinicalTrials.gov Identifier: NCT04641806
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Caroline BESSON, Versailles Hospital

Tracking Information
First Submitted Date November 20, 2020
First Posted Date November 24, 2020
Last Update Posted Date November 24, 2020
Estimated Study Start Date December 15, 2020
Estimated Primary Completion Date April 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2020)
  • Immunological response to SARS Cov2 [ Time Frame: 6 months to one year ater Covid-19 ]
    Quantification of IgG anti-SARS-Cov-2 by ELISA.
  • Clinical evolution after Covid-19 diagnosis [ Time Frame: 6 months after Covid-19 ]
    length(s) of stay(s) for Covid-19 in hospitalization and intensive care
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma
Official Title Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma
Brief Summary

France was gradually affected by SARS-Cov-2 from January 2020; it evolved in an epidemic mode in March and April 20. During the 1st phase of the epidemic, more than 250 000 cases of Covid-19 have been confirmed in France resulting in the death of more than 30,000 patients. Mortality from infection varies greatly depending on the age of the affected individuals and their comorbidities including a history of cancer. We conducted a retrospective study in 89 patients with lymphoma and Covid-19 during the first phase of the epidemic and showed a 30-day mortality of 29%. Mortality was higher in patients over 70 years of age and in a situation of relapsed or refractory disease. Lymphoma-induced hypogammaglobulinemia and / or lymphopenia as well as chemotherapy and immunotherapy treatments are known to promote the development of infections in affected individuals. Among these, anti-CD20 monoclonal antibodies, widely prescribed to treat B-cell non-Hodgkin lymphomas (B-NHL) induce a rapid depletion of over 95% of mature CD20 + B cells. This can alter the production of antibodies, and the constitution of memory responses to a new pathogen. Also, B lymphocytes have a key immunomodulatory role in the control of viral infections.

The specific immune response to SARS-CoV -2 and its evolution remain under characterization. Regardless of their neutralizing capacity, specific IgM appear 5 days after the onset of symptoms while IgG appear after 14 days. The immune response to SARS-CoV-2 also includes a T lymphocyte component, with an increase, among circulating lymphocytes, of activated CD8 and CD4 T lymphocytes. Data are still lacking on the specific response of CD4 and CD8 T lymphocytes against SARS-CoV-2, but these responses probably play a crucial role in virus clearance as well as in the immunopathology associated with SARS-CoV-2. Therapeutic depletion of B lymphocytes before acute infection may alter the generation of primary and functional responses. Therefore, a growing concern is whether patients with B-NHL who have acquired an infection with SARS-CoV-2 are protected against re-infection in the same way when they have or have not received anti-CD20 monoclonal antibodies.

Analyzing the clinical and immunological evolution of Covid-19 in patients with B-NHL is useful to adapt the treatment recommendations in their regard according to the risk of severe form of Covid-19 . This is a multicenter, prospective study to determine whether treatment with monoclonal anti-CD20 antibodies in patients with B-cell NHL modifies the clinical and immunological course of Covid-19.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples from cases and controls
Sampling Method Non-Probability Sample
Study Population Patient recruitment will be done from the hematology units of the 10 centers. The recruitment of controls will be done from the spouses of the patients. A number of 100 case patients and 20 controls is to be recruited during the 4-month inclusion period.
Condition
  • B-cell Lymphoma
  • Covid19
Intervention Not Provided
Study Groups/Cohorts
  • Lymphoma cases
    Adults aged at least 18 years, with a Covid-19 confirmed by PCR, diagnosed between February and May 2020. Past history of B-cell NHL in remission, active surveillance or during first-line or second-line treatment Affiliated with a social security, consenting to the study
  • Controls

    Adults aged at least 18 years, with a Covid-19 confirmed by PCR, diagnosed between February and May 2020. No past history of lymphoma .

    Affiliated with a social security, consenting to the study

Publications * Lamure S, Duléry R, Di Blasi R, Chauchet A, Laureana C, Deau-Fischer B, Drenou B, Soussain C, Rossi C, Noël N, Choquet S, Bologna S, Joly B, Kohn M, Malak S, Fouquet G, Daguindau E, Bernard S, Thiéblemont 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 22, 2020)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 16, 2021
Estimated Primary Completion Date April 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adults aged at least 18 years
  • Covid-19 confirmed by PCR
  • between February and May 2020
  • affiliated with a social security
  • consenting to the study

Case specific inclusion criteria :

  • being or having been affected by B-NHL
  • being currently in remission, active surveillance or during first-line or second-line treatment

Exclusion Criteria:

  • Subjects less than 18 years old
  • Subject with protective measure (curatorship, guardianship, safeguard of justice) -Subjects unable to give consent
  • Pregnant or breastfeeding women
  • Subject refusing to participate
  • Case-specific non-inclusion criteria :
  • Patient with a life expectancy linked to NHLof less than 6 months or with a History of hematopoietic allogeneic stem cell transplant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04641806
Other Study ID Numbers P20/21_LYMPHO-Cov-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Caroline BESSON, Versailles Hospital
Study Sponsor Versailles Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Versailles Hospital
Verification Date November 2020