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

NCT ID: NCT04452604

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-11

Study Completion Date

2021-07-07

Brief Summary

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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

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Conditions

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Acute Myeloblastic Leukemia Acute Lymphoblastic Leukemia SARS-CoV-2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acute Leukemia French Association

OTHER

Sponsor Role collaborator

Group for Research in Adult Acute Lymphoblastic Leukemia

OTHER

Sponsor Role collaborator

French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Yves DUMAS, Dr

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Chu Amiens

Amiens, , France

Site Status

CHU ANGERS - Maladies du sang

Angers, , France

Site Status

Ch Avignon

Avignon, , France

Site Status

CH de la Côte Basque - Hématologie

Bayonne, , France

Site Status

CHU Caen - IHBN - Hématologie Clinique

Caen, , France

Site Status

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Centre Hospitalier de Dunkerque

Dunkirk, , France

Site Status

CHU de Grenoble - Hopital Michallon

Grenoble, , France

Site Status

Centre Hospitalier du Mans

Le Mans, , France

Site Status

Hôpital Saint Vicent de Paul

Lille, , France

Site Status

Chu Limoges

Limoges, , France

Site Status

Institut Paoli-Calmettes - Hématologie 2

Marseille, , France

Site Status

HOPITAL SAINT ELOI - Hematologie

Montpellier, , France

Site Status

HOPITAL E. MULLER - Hématologie

Mulhouse, , France

Site Status

CHU HOTEL DIEU - Hématologie Clinique

Nantes, , France

Site Status

CHU Caremeau

Nîmes, , France

Site Status

CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

Perpignan, , France

Site Status

Bordeaux Pessac

Pessac, , France

Site Status

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

CHU Reims - Hôpital Robert Debré - Hématologie Clinique

Reims, , France

Site Status

CHU Pontchaillou - Hématologie

Rennes, , France

Site Status

Chu de La Reunion - Site Sud

Saint-Pierre, , France

Site Status

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Institut Universitaire du Cancer de Toulouse Oncopole - Service d'Hématologie

Toulouse, , France

Site Status

CHU de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Centre Hospitalier de Versailles

Versailles, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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COVLA

Identifier Type: -

Identifier Source: org_study_id

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