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

NCT ID: NCT04391946

Last Updated: 2023-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-14

Study Completion Date

2023-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data registry

Collection of clinical data, treatment regimens and survival data

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role collaborator

French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc-Matthieu FORNECKER, Pr

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Chu Angers

Angers, , France

Site Status

CHU Jean Minjoz - Hématologie

Besançon, , France

Site Status

Hôpital Avicenne - Centre de Recherche Clinique

Bobigny, , France

Site Status

CHU Estaing - Hématologie Clinique Adulte

Clermont-Ferrand, , France

Site Status

Chu Creteil

Créteil, , France

Site Status

CHU Grenoble - Hématologie

Grenoble, , France

Site Status

Chd Vendee

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Hôpital Saint Vicent de Paul

Lille, , France

Site Status

Centre Léon Bérard - Hématologie

Lyon, , France

Site Status

Institut Paoli Calmette

Marseille, , France

Site Status

Hopital E.Muller

Mulhouse, , France

Site Status

CHU DE NANTES - Hematologie clinique

Nantes, , France

Site Status

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

Paris, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

Poitiers, , France

Site Status

Hôpital Robert Debré - Hématologie Clinique

Reims, , France

Site Status

Centre Henri Becquerel - Service Hématologie Clinique

Rouen, , France

Site Status

Hôpital Hautepierre - Hématologie

Strasbourg, , France

Site Status

IUCT ONCOPOLE - Hématologie

Toulouse, , France

Site Status

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

Tours, , France

Site Status

CHU Nancy Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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FILO-COVID19_LLC-MW

Identifier Type: -

Identifier Source: org_study_id

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