Observational study of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma in France
French Observational Study of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in Real-World Settings
This study is looking to gather information on how patients with chronic lymphocytic leukemia or small lymphocytic lymphoma in France are being treated and managed, especially with new therapies and tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Innovative Leukemia Organisation Academic / other |
| Drugs / interventions | immunotherapy, rituximab, ibrutinib, cyclophosphamide, fludarabine |
| Locations | 57 sites (Amiens and 56 other locations) |
| Trial ID | NCT05590702 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on patients diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in France. It will assess the management and treatment strategies employed for these patients, particularly in light of recent advancements in targeted therapies and genetic evaluations. The study will include patients aged 18 and older who require a therapeutic strategy, whether they are newly diagnosed or previously treated. Data will be collected from multiple centers across France to provide a comprehensive overview of current practices and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with CLL or SLL who require a therapeutic strategy.
Not a fit: Patients who do not have CLL or SLL or those who are not requiring therapy for their condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of CLL and SLL management, leading to improved treatment strategies and patient outcomes.
How similar studies have performed: Other studies have successfully utilized observational approaches to gather data on CLL and SLL, indicating that this methodology is both valid and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with no need of therapy * Patients with asymptomatic Binet A CLL * Patient with Richter's syndrome at inclusion * Patient requiring immunoglobulin substitution (with no need of a more specific therapy)
Where this trial is running
Amiens and 56 other locations
- AMIENS - CH Amiens Picardie Site Sud — Amiens, France (Not_yet_recruiting)
- Angers Chu — Angers, France (Recruiting)
- ANNECY - CH Annecy Genevois — Annecy, France (Recruiting)
- ARGENTEUIL - Centre hospitalier Victor Dupouy — Argenteuil, France (Recruiting)
- AVIGNON - Centre Hospitalier — Avignon, France (Not_yet_recruiting)
- BESANCON - Hôpital Jean Minjoz — Besançon, France (Not_yet_recruiting)
- Blois Ch — Blois, France (Not_yet_recruiting)
- APHP - Hôpital Avicenne — Bobigny, France (Not_yet_recruiting)
- APHP - Hôpital Jean Verdier — Bondy, France (Not_yet_recruiting)
- BOURGOUIN-JALLIEU - CH Pierre Oudot — Bourgoin-Jallieu, France (Not_yet_recruiting)
- BREST - Hôpital Morvan - Hématologie Clinique — Brest, France (Not_yet_recruiting)
- BEZIERS - Centre Hospitalier - Hématologie — Béziers, France (Not_yet_recruiting)
- CAEN - IHBN - Hématologie Clinique — Caen, France (Recruiting)
- CERGY PONTOISE - CH René Dubos — Cergy-Pontoise, France (Not_yet_recruiting)
- CHAMBERY - CH Métropole Savoie — Chambéry, France (Recruiting)
- Clermont-Ferrand - Chu Estaing — Clermont-Ferrand, France (Recruiting)
- Corbeil-Essonnes - Chsf — Corbeil-Essonnes, France (Not_yet_recruiting)
- Dijon Chu — Dijon, France (Not_yet_recruiting)
- GRENOBLE GHM - Institut Daniel Hollard — Grenoble, France (Not_yet_recruiting)
- Grenoble - CHUGA - Hématologie Clinique — Grenoble, France (Not_yet_recruiting)
- La Roche Sur Yon - Chd Vendee — La Roche-sur-Yon, France (Recruiting)
- Le Mans CH — Le Mans, France (Not_yet_recruiting)
- LENS - GHT Artois — Lens, France (Not_yet_recruiting)
- LIBOURNE - Hôpital Robert Boulin — Libourne, France (Not_yet_recruiting)
- LILLE GHICL - Hôpital Saint Vincent de Paul — Lille, France (Not_yet_recruiting)
- LILLE CHU - Hôpital Claude Huriez — Lille, France (Recruiting)
- LIMOGES - CHU Dupuytren 1 — Limoges, France (Not_yet_recruiting)
- LYON-Centre Léon Bérard — Lyon, France (Not_yet_recruiting)
- METZ-THIONVILLE CHR- Hôpital de Mercy — Metz, France (Not_yet_recruiting)
- MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique — Montpellier, France (Not_yet_recruiting)
- MORLAIX - CH des pays de Morlaix — Morlaix, France (Recruiting)
- Mulhouse - Ghrmsa — Mulhouse, France (Not_yet_recruiting)
- NANTES - Hôpital Hôtel Dieu - Hématologie Clinique — Nantes, France (Recruiting)
- NIMES - CHU Caremeau — Nîmes, France (Not_yet_recruiting)
- ORLEANS - CHR - Hématologie — Orléans, France (Recruiting)
- APHP - HOPITAL COCHIN - Hématologie — Paris, France (Not_yet_recruiting)
- APHP - Hôpital Pitié Salpêtrière - Hématologie — Paris, France (Not_yet_recruiting)
- PERPIGNAN - CH St Jean - Hématologie Clinique — Perpignan, France (Not_yet_recruiting)
- Bordeaux Pessac — Pessac, France (Recruiting)
- LYON HCL - CH Lyon Sud — Pierre-Bénite, France (Recruiting)
- Perigueux - Ch — Périgueux, France (Recruiting)
- QUIMPER - CH de Cornouaille — Quimper, France (Not_yet_recruiting)
- Reims Chu — Reims, France (Not_yet_recruiting)
- RENNES - CHU Pontchaillou - Hématologie Clinique — Rennes, France (Not_yet_recruiting)
- RENNES - Hôpital Pontchaillou - Hématologie — Rennes, France (Not_yet_recruiting)
- ROUEN - Centre Henri Becquerel - Service Hématologie Clinique — Rouen, France (Recruiting)
- SAINT-BRIEUC - Hôpila Yves Le Foll — Saint-Brieuc, France (Not_yet_recruiting)
- La Reunion - Gh Site Sud — Saint-pierre, France (Recruiting)
- ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth — Saint-Priest-en-Jarez, France (Recruiting)
- Strasbourg - Icans — Strasbourg, France (Not_yet_recruiting)
+7 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Romain GUIEZE — French Innovative Leukemia Organisation
- Study coordinator: Valérie ROUILLE
- Email: v.rouille@filo-leucemie.org
- Phone: 04 67 33 26 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.