Last reviewed · How we verify
NCT04641806: LYMPHO-Cov-2
Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma
trial in B-cell Lymphoma. Withdrawn.
1 November 2020
Quick facts
| Lead sponsor | Versailles Hospital |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 1 November 2020 |
| Primary completion | 1 November 2020 |
| Estimated completion | 1 November 2020 |
Conditions studied
- B-cell Lymphoma — all drugs for B-cell Lymphoma →
- Covid19 — all drugs for Covid19 →
Sponsor
Versailles Hospital
Who can join
18 and older, any sex, with B-cell Lymphoma or Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04641806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for B-cell Lymphoma
Currently open trials in the same condition.
- NCT07211048 — Anti CD19 Gene Therapy for B-cell Lymphoma · NA · recruiting
- NCT06758713 — Safety and Efficacy of Fourth-Generation CAR-T in the Treatment of Hematologic Malignancies · Phase 1 · recruiting
- NCT06820268 — A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies · Phase 1 · recruiting
- NCT06208735 — CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies · Phase 1 · recruiting
- NCT06744075 — Study of the Clearance of Minimal Residual Disease Measured at the End of First-line Treatment in Patients With Lymphoma · NA · active not recruiting
Other Versailles Hospital trials
Trials by the same sponsor.
- NCT07369245 — Techniques for Activating Consciousness (TAC) for Outpatients With Moderate to Severe Alcohol Addiction · NA · not yet recruiting
- NCT07383779 — Targeted Hypothermia Versus Targeted Normothermia After Convulsive Refractory Status Epilepticus · Phase 3 · not yet recruiting
- NCT06835491 — Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac · Phase 3 · recruiting
- NCT07476755 — Cross-cultural Adaptation and Validation of the French Version of the Social Media Disorder Scale for Parents in a Sampl · completed
- NCT06650813 — Adapting the FACETS Program to Sickle Cell Disease · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04641806 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Versailles Hospital
- Last refreshed: 19 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04641806.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing