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

NCT04391946 | Completed

• 1 other identifier: FILO-COVID19_LLC-MW
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease

Outcome Measures

Primary Outcomes (1)

• Prognostic factors for healing of COVID-19 infection

  Hematological pathology Description

  Day 0

Secondary Outcomes (2)

• Medical care of Coronavirus infection

  within 12 months after diagnosis

• national epidemiological monitoring

  through study completion, an average of 2 years

Interventions

Data registry BEHAVIORAL

Collection of clinical data, treatment regimens and survival data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient opposition

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• Institut de cancérologie Strasbourg Europe: collaborator

Study Sites (22)

Chu Angers

Angers, 49933, France

Location

CHU Jean Minjoz - Hématologie

Besançon, 25000, France

Location

Hôpital Avicenne - Centre de Recherche Clinique

Bobigny, 93009, France

Location

CHU Estaing - Hématologie Clinique Adulte

Clermont-Ferrand, 63000, France

Location

Chu Creteil

Créteil, 94000, France

Location

CHU Grenoble - Hématologie

Grenoble, 388043, France

Location

Chd Vendee

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier du Mans

Le Mans, 72000, France

Location

Hôpital Saint Vicent de Paul

Lille, 59000, France

Location

Centre Léon Bérard - Hématologie

Lyon, 69373, France

Location

Institut Paoli Calmette

Marseille, 130009, France

Location

Hopital E.Muller

Mulhouse, 68100, France

Location

CHU DE NANTES - Hematologie clinique

Nantes, 44093, France

Location

Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

Poitiers, 86021, France

Location

Hôpital Robert Debré - Hématologie Clinique

Reims, 51092, France

Location

Centre Henri Becquerel - Service Hématologie Clinique

Rouen, 76038, France

Location

Hôpital Hautepierre - Hématologie

Strasbourg, 67098, France

Location

IUCT ONCOPOLE - Hématologie

Toulouse, 31059, France

Location

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

Tours, 37044, France

Location

CHU Nancy Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Routinely Collected Health Data

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Surveys; Health Services Research; Health Planning; Health Care Economics and Organizations; Health Care Quality, Access, and Evaluation

Study Officials

• Luc-Matthieu FORNECKER, Pr

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: March 14, 2020
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)