Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19

Acute Lymphoblastic Leukemia Clinical Trial

— COVLA  

Official title:

National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452604
• Other study ID #: COVLA
• Status: Completed
• Start date: September 11, 2020
• Est. completion date: July 7, 2021

Study information

• Verified date: July 2022
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-19 epidemic (Coronavirus Disease 2019) currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). Epidemiologically, acute myeloblastic leukemias (AML) are the most common of acute leukemias. The incidence of acute lymphoblastic leukemia (ALL) is 900 new cases in France in 2018, of which 57% in humans. The treatments administered to AML and ALL patients induce variable immunosuppression: neutropenia, neuropathy, deficits in humoral or cellular immunity or combinations of these deficits. Patients with AML or ALL therefore represent a population at high risk of developing a serious form in the event of infection with SARS-CoV-2. To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in the population of patients with acute leukemia. The main objective of the study is to determine the clinical and biological prognostic factors during SARS-CoV-2 infection in patients with acute leukemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 7, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of acute leukemia according to WHO criteria 2016 = 5 years
• Diagnosis of a proven or probable SARS-CoV-2 infection according to the following

criteria:

1. Proven infection: positive Polymerase Chain Reaction (PCR) regardless of the radio-clinical picture (other tests made available later and having good diagnostic performance will be accepted)

2. Probable infection: negative PCR but association of

1. Evocative clinical signs, of recent installation: fever, respiratory signs (cough, dyspnea, chest pain), body aches, sore throat, rhinorrhea, headache, diarrhea / abdominal pain, frank asthenia, loss of taste / smell, conjunctivitis, type of frostbite AND

2. evocative radiological signs, on CT: diffuse or diffuse aspect of frosted glass, condensations including pseudo-nodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on chest radiography: interstitial, alveolo-interstitial or alveolar syndrome, single or bilateral AND

3. absence of differential diagnosis

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloblastic Leukemia
• Leukemia
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• SARS-CoV-2

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	CHU ANGERS - Maladies du sang	Angers
France	Ch Avignon	Avignon
France	CH de la Côte Basque - Hématologie	Bayonne
France	CHU Caen - IHBN - Hématologie Clinique	Caen
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes
France	Centre Hospitalier de Dunkerque	Dunkerque
France	CHU de Grenoble - Hopital Michallon	Grenoble
France	Centre Hospitalier du Mans	Le Mans
France	Hôpital Saint Vicent de Paul	Lille
France	Chu Limoges	Limoges
France	Institut Paoli-Calmettes - Hématologie 2	Marseille
France	HOPITAL SAINT ELOI - Hematologie	Montpellier
France	HOPITAL E. MULLER - Hématologie	Mulhouse
France	CHU HOTEL DIEU - Hématologie Clinique	Nantes
France	CHU Caremeau	Nîmes
France	CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique	Perpignan
France	Bordeaux Pessac	Pessac
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	CHU Reims - Hôpital Robert Debré - Hématologie Clinique	Reims
France	CHU Pontchaillou - Hématologie	Rennes
France	Chu de La Reunion - Site Sud	Saint-pierre
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez
France	Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie	Toulouse
France	CHU de Brabois	Vandœuvre-lès-Nancy
France	Centre Hospitalier de Versailles	Versailles
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Acute Leukemia French Association, Group for Research in Adult Acute Lymphoblastic Leukemia

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical prognostic factors for infection with COVID-19	Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)	Day 0
Primary	Biological prognostic factors for infection with COVID-19	neutrophils and lymphocytes count at the time of SARS-COV2 infection	Day 0
Primary	Medical care of Coronavirus infection	Describe the management carried out concerning coronavirus infection and its impact of the treatment of acute leukemia (non-invasive ventilation, orotracheal intubation, vasopressor requiring, treatments used, cause of death	within 12 months after diagnosis