Clinical trial NCT04452604: Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Official title: National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloblastic Leukemia
Acute Lymphoblastic Leukemia
SARS-CoV-2
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Acute Leukemia French Association
name: Group for Research in Adult Acute Lymphoblastic Leukemia
First posted: 2020-06-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 infected patients with AML or ALL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical prognostic factors for infection with COVID-19
timeFrame: Day 0
measure: Biological prognostic factors for infection with COVID-19
timeFrame: Day 0
measure: Medical care of Coronavirus infection
timeFrame: within 12 months after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Angers
country: France
facility: CHU ANGERS - Maladies du sang
city: Avignon
country: France
facility: Ch Avignon
city: Bayonne
country: France
facility: CH de la Côte Basque - Hématologie
city: Caen
country: France
facility: CHU Caen - IHBN - Hématologie Clinique
city: Corbeil-essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Grenoble
country: France
facility: CHU de Grenoble - Hopital Michallon
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: Hôpital Saint Vicent de Paul
city: Limoges
country: France
facility: Chu Limoges
city: Marseille
country: France
facility: Institut Paoli-Calmettes - Hématologie 2
city: Montpellier
country: France
facility: HOPITAL SAINT ELOI - Hematologie
city: Mulhouse
country: France
facility: HOPITAL E. MULLER - Hématologie
city: Nantes
country: France
facility: CHU HOTEL DIEU - Hématologie Clinique
city: Nîmes
country: France
facility: CHU Caremeau
city: Perpignan
country: France
facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique
city: Pessac
country: France
facility: Bordeaux Pessac
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: CHU Reims - Hôpital Robert Debré - Hématologie Clinique
city: Rennes
country: France
facility: CHU Pontchaillou - Hématologie
city: Saint-pierre
country: France
facility: Chu de La Reunion - Site Sud
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Brabois
city: Versailles
country: France
facility: Centre Hospitalier de Versailles
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Pierre-Yves DUMAS, Dr
role: PRINCIPAL_INVESTIGATOR
References: