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

Overview

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.

Full Title of Study: “National Retrospective Monitoring of Patients With Acute Leukemia Infected by COronaVirus Disease 2019 (COVID-19)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 1, 2023

Clinical Trial Outcome Measures

Primary Measures

  • Clinical prognostic factors for infection with COVID-19
    • Time Frame: 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
    • Time Frame: Day 0
    • neutrophils and lymphocytes count at the time of SARS-COV2 infection
  • Medical care of Coronavirus infection
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French Innovative Leukemia Organisation
  • Collaborator
    • Acute Leukemia French Association
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre-Yves DUMAS, Dr, Principal Investigator, French Innovative Leukemia Organisation
  • Overall Contact(s)
    • Pierre-Yves DUMAS, Dr, 0557656514, pierre-yves.dumas@chu-bordeaux.fr

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