French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings
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1 other identifier
observational
1,000
1 country
57
Brief Summary
Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation. We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Longer than P75 for all trials
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 21, 2022
CompletedStudy Start
First participant enrolled
November 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
ExpectedDecember 3, 2025
November 1, 2025
2.4 years
October 17, 2022
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Representativity of CLL therapies and sequences across
Number of patients who received a particular type of therapy (chemo-immunotherapy, kinase inhibitors targeting the B-cell receptor signaling, B-cell lymphoma 2 inhibitor) at baseline and in relapse and in which sequence
7-year period of time
Secondary Outcomes (2)
Overall survival
7 years
Long-term toxicity
7 years
Interventions
Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation will be identified in MCM (multidisciplinary collegial meeting). Patients will be treated and managed according to the decision of their physicians and the related MDM. No treatment plan is recommended in the setting of this non-interventional study.
Eligibility Criteria
Patient with CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation will be identified in MCM (multidisciplinary collegial meeting).
You may qualify if:
- Age ≥ 18-year old
- CLL or SLL requiring a therapeutic strategy according to iwCLL criteria or investigator evaluation
- Patient requiring therapy for immune events (autoimmune Thrombocytopenia and autoimmune hemolytic anemia) are eligible
- Patients who have been informed verbally and in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control
- All consecutive patients for whom a discussion in the setting of local or regional multidisciplinary collegial meeting (in french : réunion de concertation pluridisciplinaire / RCP) has retained the need for starting a therapeutic strategy (curative or palliative)
- Patients with untreated or previously treated CLL/SLL are both eligible
- Patients enrolled in a clinical trial can be included in this non-interventional cohort study
- Patients requiring therapy for CLL/SLL-associated immune events only are also eligible
You may not qualify if:
- Patients with no need of therapy
- Patients with asymptomatic Binet A CLL
- Patient requiring immunoglobulin substitution (with no need of a more specific therapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- French Innovative Leukemia Organisationlead
- AbbViecollaborator
- AstraZenecacollaborator
- BeiGenecollaborator
- Janssen-Cilag Ltd.collaborator
Study Sites (57)
AMIENS - CH Amiens Picardie Site Sud
Amiens, 80054, France
Angers Chu
Angers, 49933, France
ANNECY - CH Annecy Genevois
Annecy, 74374, France
ARGENTEUIL - Centre hospitalier Victor Dupouy
Argenteuil, France
AVIGNON - Centre Hospitalier
Avignon, 84000, France
BESANCON - Hôpital Jean Minjoz
Besançon, 25000, France
BEZIERS - Centre Hospitalier - Hématologie
Béziers, 34500, France
BLOIS CH
Blois, 41000, France
APHP - Hôpital Avicenne
Bobigny, France
APHP - Hôpital Jean Verdier
Bondy, 93140, France
BOURGOUIN-JALLIEU - CH Pierre Oudot
Bourgoin, 38300, France
BREST - Hôpital Morvan - Hématologie Clinique
Brest, 29609, France
CAEN - IHBN - Hématologie Clinique
Caen, 14033, France
CERGY PONTOISE - CH René Dubos
Cergy-Pontoise, France
CHAMBERY - CH Métropole Savoie
Chambéry, 73000, France
Clermont-Ferrand - Chu Estaing
Clermont-Ferrand, 63000, France
Corbeil-Essonnes - Chsf
Corbeil-Essonnes, France
Dijon Chu
Dijon, 21000, France
GRENOBLE GHM - Institut Daniel Hollard
Grenoble, 38028, France
Grenoble - CHUGA - Hématologie Clinique
Grenoble, 38043, France
La Roche Sur Yon - Chd Vendee
La Roche-sur-Yon, 85925, France
Le Mans CH
Le Mans, France
LENS - GHT Artois
Lens, 62300, France
LIBOURNE - Hôpital Robert Boulin
Libourne, 33505, France
LILLE GHICL - Hôpital Saint Vincent de Paul
Lille, 59000, France
LILLE CHU - Hôpital Claude Huriez
Lille, 59037, France
LIMOGES - CHU Dupuytren 1
Limoges, 87042, France
LYON-Centre Léon Bérard
Lyon, 69008, France
METZ-THIONVILLE CHR- Hôpital de Mercy
Metz, France
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique
Montpellier, 34295, France
MORLAIX - CH des pays de Morlaix
Morlaix, 29672, France
Mulhouse - Ghrmsa
Mulhouse, 68100, France
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique
Nantes, 44093, France
NIMES - CHU Caremeau
Nîmes, 30029, France
ORLEANS - CHR - Hématologie
Orléans, 44100, France
APHP - HOPITAL COCHIN - Hématologie
Paris, 75014, France
APHP - Hôpital Pitié Salpêtrière - Hématologie
Paris, 75651, France
PERPIGNAN - CH St Jean - Hématologie Clinique
Perpignan, 66000, France
Bordeaux Pessac
Pessac, 33604, France
Perigueux - Ch
Périgueux, 24000, France
LYON HCL - CH Lyon Sud
Pierre-Bénite, 69036, France
QUIMPER - CH de Cornouaille
Quimper, 29000, France
Reims Chu
Reims, 51092, France
RENNES - CHU Pontchaillou - Hématologie Clinique
Rennes, 35033, France
RENNES - Hôpital Pontchaillou - Hématologie
Rennes, 35033, France
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique
Rouen, 76038, France
SAINT-BRIEUC - Hôpila Yves Le Foll
Saint-Brieuc, 22027, France
La Reunion - Gh Site Sud
Saint-Pierre, France
ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France
Strasbourg - Icans
Strasbourg, 67033, France
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse, 31059, France
TOURS - Hôpital Bretonneau
Tours, 37000, France
Troyes Ch
Troyes, France
NANCY - CHU Brabois
Vandœuvre-lès-Nancy, 54500, France
Vannes - Chba
Vannes, France
VERSAILLES - Hôpital André Mignot
Versailles, France
Villejuif Igr
Villejuif, France
Study Officials
- PRINCIPAL INVESTIGATOR
Romain GUIEZE
French Innovative Leukemia Organisation
- STUDY CHAIR
Xavier TROUSSARD
French Innovative Leukemia Organisation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 21, 2022
Study Start
November 11, 2022
Primary Completion
April 18, 2025
Study Completion (Estimated)
December 1, 2032
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share