Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom DiseaseCOVID19_LLC-MWNCT04391946
Observatory of Patients With Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenstrom Disease Infected With COVID-19
An observational study of Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease, run by French Innovative Leukemia Organisation at 22 sites in France.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease
- What is being tested?
- Data registry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 162 participants
- Where
- 22 sitesFrance
- Study dates
- 14 Mar 2020to 10 Mar 2023
- How long will I take part?
- 12 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 infected patients with chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenström disease
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- Patient opposition
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
France22 sites
Chu Angers
Angers, 49933
CHU Jean Minjoz - Hématologie
Besançon, 25000
Hôpital Avicenne - Centre de Recherche Clinique
Bobigny, 93009
CHU Estaing - Hématologie Clinique Adulte
Clermont-Ferrand, 63000
Chu Creteil
Créteil, 94000
CHU Grenoble - Hématologie
Grenoble, 388043
Chd Vendee
La Roche-sur-Yon, 85925
Centre Hospitalier du Mans
Le Mans, 72000
Hôpital Saint Vicent de Paul
Lille, 59000
Centre Léon Bérard - Hématologie
Lyon, 69373
Institut Paoli Calmette
Marseille, 130009
Hopital E.Muller
Mulhouse, 68100
CHU DE NANTES - Hematologie clinique
Nantes, 44093
Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent
Paris, 75651
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire
Poitiers, 86021
Hôpital Robert Debré - Hématologie Clinique
Reims, 51092
Centre Henri Becquerel - Service Hématologie Clinique
Rouen, 76038
Hôpital Hautepierre - Hématologie
Strasbourg, 67098
IUCT ONCOPOLE - Hématologie
Toulouse, 31059
Hôpital Bretonneau - Hématologie et Thérapie Cellulaire
Tours, 37044
CHU Nancy Brabois
Vandœuvre-lès-Nancy, 54500
About this study
Official title: National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
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.
- Being tested
- Data registry
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data registryBehavioural
Collection of clinical data, treatment regimens and survival data
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic factors for healing of COVID-19 infection
Hematological pathology Description
Measured: Day 0
Secondary outcomes (2)
Medical care of Coronavirus infection
Describe the management carried out concerning Coronavirus infection and its impact on the treatment of hemopathy.
Measured: within 12 months after diagnosis
national epidemiological monitoring
Allow national epidemiological monitoring and regularly inform the hematology community.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start14 Mar 2020
- Primary completion10 Mar 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de cancérologie Strasbourg Europe
- Responsible party
- Sponsor
- Investigators
- Luc-Matthieu FORNECKER, Pr, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391946
- Sponsor's protocol ID
- FILO-COVID19_LLC-MW
- Acronym
- COVID19_LLC-MW
- Status last verified
- May 2023
- First submitted
- 13 May 2020
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease
- ClinicalTrials.gov ID
- NCT04391946
- Acronym / sponsor ID
- COVID19_LLC-MW / FILO-COVID19_LLC-MW
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Institut de cancérologie Strasbourg Europe
- Study start
- 14 Mar 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 infected patients with chronic lymphocytic leukemia / lymphocytic lymphoma or Waldenström disease
Key inclusion criteria (18 listed)
- 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:
- Minor criteria
Key exclusion criteria (1 listed)
- Patient opposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data registryCollection of clinical data, treatment regimens and survival data | Behavioural | – |
Primary outcome
Prognostic factors for healing of COVID-19 infection
Time frame: Day 0
Hematological pathology Description
2 secondary outcomes
Medical care of Coronavirus infection
Time frame: within 12 months after diagnosis
national epidemiological monitoring
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc-Matthieu FORNECKER, Pr principal investigator
French Innovative Leukemia Organisation
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma or Waldenstrom Disease, run by French Innovative Leukemia Organisation at 22 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic factors for healing of COVID-19 infection (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.