Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19 (COVID19_LLC-MW)

National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012.

Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection.

To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
• Intervention / Treatment: Behavioral: Data registry

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

• Study Contact: Name: Raoul HERBRECHT, Pr; Phone Number: 33 3 88 68 76 73 73; Email: r.herbrecht@icans.eu
• Study Contact Backup: Name: Valérie ROUILLE; Phone Number: +33 4 67 33 26 45; Email: v-rouille@chu-montpellier.fr

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers
  • Besançon, France, 25000
    • CHU Jean Minjoz - Hématologie
  • Bobigny, France, 93009
    • Hôpital Avicenne - Centre de Recherche Clinique
  • Clermont-Ferrand, France, 63000
    • CHU Estaing - Hématologie Clinique Adulte
  • Créteil, France, 94000
    • CHU Créteil
  • Grenoble, France, 388043
    • CHU Grenoble - Hématologie
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • Le Mans, France, 72000
    • Centre Hospitalier Du Mans
  • Lille, France, 59000
    • Hôpital Saint Vicent de Paul
  • Lyon, France, 69373
    • Centre Léon Bérard - Hématologie
  • Marseille, France, 130009
    • Institut Paoli Calmette
  • Mulhouse, France, 68100
    • Hopital E.Muller
  • Nantes, France, 44093
    • CHU De Nantes - Hématologie Clinique
  • Paris, France, 75651
    • Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud
  • Poitiers, France, 86021
    • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire
  • Reims, France, 51092
    • Hôpital Robert Debré - Hématologie Clinique
  • Rouen, France, 76038
    • Centre Henri Becquerel - Service Hématologie Clinique
  • Strasbourg, France, 67098
    • Hôpital Hautepierre - Hématologie
  • Toulouse, France, 31059
    • IUCT ONCOPOLE - Hématologie
  • Tours, France, 37044
    • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire
  • Vandœuvre-lès-Nancy, France, 54500
    • CHU Nancy Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 infected patients with chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenström disease

Description

Inclusion Criteria:

• Diagnosis of chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenstrom disease according to the criteria of the WHO 2016 with a proven or probable infection by COVID-19 according to the following criteria:
• Proven infection: PCR positive regardless of the radio-clinical picture (Other tests made available later and having good diagnostic performance will be accepted)
• Probable infection: the diagnosis of probable infection is retained in case of negative PCR or not made if presence of at least 2 major criteria or of a major criterion associated with at least 2 minor criteria among the following, in the absence other documented cause.

• Major criteria:

  • Fever
  • Loss of smell / taste
  • At least one respiratory sign among cough, dyspnea, chest pain
  • Radiological signs suggestive of the scanner (areas or diffuse appearance of frosted glass, condensations including pseudonodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on an X-ray of the thorax ( interstitial, alveolo-interstitial or alveolar syndrome, unilateral or bilateral)
  • Notion of storytelling with a person whose SARS-CoV-2 infection has been formally documented

• Minor criteria

  • Aches
  • Sore throat
  • Rhinorrhea
  • Headache
  • Diarrhea
  • Abdominal pain
  • Frank asthenia
  • Conjunctivitis

Exclusion Criteria:

• Patient opposition

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic factors for healing of COVID-19 infection	Hematological pathology Description	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical care of Coronavirus infection	Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.	within 12 months after diagnosis
national epidemiological monitoring	Allow national epidemiological monitoring and regularly inform the hematology community.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: French Innovative Leukemia Organisation
• Collaborators: Institut de cancérologie Strasbourg Europe
• Investigators: Principal Investigator: Luc-Matthieu FORNECKER, Pr, French Innovative Leukemia Organisation

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2020
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Leukemia, B-Cell; Cartilage Diseases; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Osteochondritis
• Other Study ID Numbers: FILO-COVID19_LLC-MW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No