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

Completed

• Conditions: SARS-CoV-2; Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia

• Registration Number: NCT04452604
• Lead Sponsor: French Innovative Leukemia Organisation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Study Start: 2020-09-11
• Primary Completion: 2021-06-30
• Study Completion: 2021-07-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical prognostic factors for infection with COVID-19	Day 0	Factors associated with overall survival will be analyzed : center, sex, leukemia subtype, previous treatment by corticosteroids, and comorbidities (respiratory, renal, cardiac, weight, diabetes)
Biological prognostic factors for infection with COVID-19	Day 0	neutrophils and lymphocytes count at the time of SARS-COV2 infection
Medical care of Coronavirus infection	within 12 months after diagnosis	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

Trial Locations

Locations (27)

Chu Limoges; 🇫🇷 Limoges, France

Bordeaux Pessac; 🇫🇷 Pessac, France

Institut de Cancérologie Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

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

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

Chu de La Reunion - Site Sud; 🇫🇷 Saint-pierre, France

Chu Amiens; 🇫🇷 Amiens, France

CHU Caen - IHBN - Hématologie Clinique; 🇫🇷 Caen, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes, France

CHU de Grenoble - Hopital Michallon; 🇫🇷 Grenoble, France

Hôpital Saint Vicent de Paul; 🇫🇷 Lille, France

CHU HOTEL DIEU - Hématologie Clinique; 🇫🇷 Nantes, France

CHU Caremeau; 🇫🇷 Nîmes, France

CHU ANGERS - Maladies du sang; 🇫🇷 Angers, France

CH de la Côte Basque - Hématologie; 🇫🇷 Bayonne, France

Centre Hospitalier de Dunkerque; 🇫🇷 Dunkerque, France

HOPITAL SAINT ELOI - Hematologie; 🇫🇷 Montpellier, France

HOPITAL E. MULLER - Hématologie; 🇫🇷 Mulhouse, France

CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique; 🇫🇷 Perpignan, France

Centre Hospitalier du Mans; 🇫🇷 Le Mans, France

CHU Pontchaillou - Hématologie; 🇫🇷 Rennes, France

Institut Paoli-Calmettes - Hématologie 2; 🇫🇷 Marseille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, 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

Ch Avignon; 🇫🇷 Avignon, France