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Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19 (COVID19_LLC-MW)

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ClinicalTrials.gov Identifier: NCT04391946
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Institut de cancérologie Strasbourg Europe
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

Brief Summary:

The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012.

Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection.

To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.


Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease Behavioral: Data registry

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Years
Official Title: National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
Actual Study Start Date : March 14, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : December 31, 2022



Intervention Details:
  • Behavioral: Data registry
    Collection of clinical data, treatment regimens and survival data


Primary Outcome Measures :
  1. Prognostic factors for healing of COVID-19 infection [ Time Frame: Day 0 ]
    Hematological pathology Description


Secondary Outcome Measures :
  1. Medical care of Coronavirus infection [ Time Frame: within 12 months after diagnosis ]
    Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.

  2. national epidemiological monitoring [ Time Frame: through study completion, an average of 2 years ]
    Allow national epidemiological monitoring and regularly inform the hematology community.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID-19 infected patients with chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenström disease
Criteria

Inclusion Criteria:

  • Diagnosis of chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenstrom disease according to the criteria of the WHO 2016 with a proven or probable infection by COVID-19 according to the following criteria:
  • Proven infection: PCR positive regardless of the radio-clinical picture (Other tests made available later and having good diagnostic performance will be accepted)
  • Probable infection: the diagnosis of probable infection is retained in case of negative PCR or not made if presence of at least 2 major criteria or of a major criterion associated with at least 2 minor criteria among the following, in the absence other documented cause.
  • Major criteria:

    • Fever
    • Loss of smell / taste
    • At least one respiratory sign among cough, dyspnea, chest pain
    • Radiological signs suggestive of the scanner (areas or diffuse appearance of frosted glass, condensations including pseudonodular condensations, association of frosted glass and condensation within the same lesion, nodules and micronodules, thickening of the interlobular septa) or on an X-ray of the thorax ( interstitial, alveolo-interstitial or alveolar syndrome, unilateral or bilateral)
    • Notion of storytelling with a person whose SARS-CoV-2 infection has been formally documented
  • Minor criteria

    • Aches
    • Sore throat
    • Rhinorrhea
    • Headache
    • Diarrhea
    • Abdominal pain
    • Frank asthenia
    • Conjunctivitis

Exclusion Criteria:

  • Patient opposition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391946


Contacts
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Contact: Raoul HERBRECHT, Pr 3 88 68 76 73 73 ext 33 r.herbrecht@icans.eu
Contact: Valérie ROUILLE 4 67 33 26 45 ext +33 v-rouille@chu-montpellier.fr

Locations
Show Show 22 study locations
Sponsors and Collaborators
French Innovative Leukemia Organisation
Institut de cancérologie Strasbourg Europe
Investigators
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Principal Investigator: Luc-Matthieu FORNECKER, Pr French Innovative Leukemia Organisation
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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT04391946    
Other Study ID Numbers: FILO-COVID19_LLC-MW
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Osteochondritis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bone Diseases
Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases