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

Completed

• Conditions: Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease

• Registration Number: NCT04391946
• Lead Sponsor: French Innovative Leukemia Organisation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-14
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Primary Completion: 2022-03-10
• Study Completion: 2023-03-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic factors for healing of COVID-19 infection	Day 0	Hematological pathology Description

Secondary Outcome Measures

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

Trial Locations

Locations (22)

CHU Estaing - Hématologie Clinique Adulte; 🇫🇷 Clermont-Ferrand, France

Centre Henri Becquerel - Service Hématologie Clinique; 🇫🇷 Rouen, France

Chu Angers; 🇫🇷 Angers, France

CHU Jean Minjoz - Hématologie; 🇫🇷 Besançon, France

Chd Vendee; 🇫🇷 La Roche-sur-Yon, France

Hôpital Avicenne - Centre de Recherche Clinique; 🇫🇷 Bobigny, France

Chu Creteil; 🇫🇷 Créteil, France

CHU Grenoble - Hématologie; 🇫🇷 Grenoble, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France

Centre Léon Bérard - Hématologie; 🇫🇷 Lyon, France

Hôpital Saint Vicent de Paul; 🇫🇷 Lille, France

Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent; 🇫🇷 Paris, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Hopital E.Muller; 🇫🇷 Mulhouse, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

CHU DE NANTES - Hematologie clinique; 🇫🇷 Nantes, France

Hôpital Hautepierre - Hématologie; 🇫🇷 Strasbourg, France

Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire; 🇫🇷 Poitiers, France

Hôpital Robert Debré - Hématologie Clinique; 🇫🇷 Reims, France

CHU Nancy Brabois; 🇫🇷 Vandœuvre-lès-Nancy, France

IUCT ONCOPOLE - Hématologie; 🇫🇷 Toulouse, France

Hôpital Bretonneau - Hématologie et Thérapie Cellulaire; 🇫🇷 Tours, France