Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease Clinical Trial
— COVID19_LLC-MWOfficial title:
National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
| Verified date | May 2023 |
| Source | French Innovative Leukemia Organisation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | March 10, 2023 |
| Est. primary completion date | March 10, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Angers | Angers | |
| France | CHU Jean Minjoz - Hématologie | Besançon | |
| France | Hôpital Avicenne - Centre de Recherche Clinique | Bobigny | |
| France | CHU Estaing - Hématologie Clinique Adulte | Clermont-Ferrand | |
| France | Chu Creteil | Créteil | |
| France | CHU Grenoble - Hématologie | Grenoble | |
| France | Chd Vendee | La Roche-sur-Yon | |
| France | Centre Hospitalier du Mans | Le Mans | |
| France | Hôpital Saint Vicent de Paul | Lille | |
| France | Centre Léon Bérard - Hématologie | Lyon | |
| France | Institut Paoli Calmette | Marseille | |
| France | Hopital E.Muller | Mulhouse | |
| France | CHU DE NANTES - Hematologie clinique | Nantes | |
| France | Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent | Paris | |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire | Poitiers | |
| France | Hôpital Robert Debré - Hématologie Clinique | Reims | |
| France | Centre Henri Becquerel - Service Hématologie Clinique | Rouen | |
| France | Hôpital Hautepierre - Hématologie | Strasbourg | |
| France | IUCT ONCOPOLE - Hématologie | Toulouse | |
| France | Hôpital Bretonneau - Hématologie et Thérapie Cellulaire | Tours | |
| France | CHU Nancy Brabois | Vandœuvre-lès-Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| French Innovative Leukemia Organisation | Institut de cancérologie Strasbourg Europe |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prognostic factors for healing of COVID-19 infection | Hematological pathology Description | Day 0 | |
| Secondary | 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 | |
| Secondary | national epidemiological monitoring | Allow national epidemiological monitoring and regularly inform the hematology community. | through study completion, an average of 2 years |