Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05590702 En recrutement IDF

Titre

French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings (FOLLOW)

Type

Observational [Patient Registry]

Pathologie

Leucémie lymphoïde
Leucémie chronique lymphocytaire à cellules B

Phase

Promoteur

French Innovative Leukemia Organisation (Voir sur ClinicalTrials)

Date de début

novembre 2022

Date de fin

décembre 2032

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. In Europe, CLL has been identified as the second most frequent hematological malignancies after multiple myeloma (Eurocare 5 study) and its standardized incidence in the world has been estimated to be 4/100000 person-years for men and 2.1/100000 person-years for women. In France, 4674 new cases have been observed in 2018 (FRANCIM). A proportion of patients can initially be monitored only while others with symptomatic disease at diagnosis or during follow-up require therapies. 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. Conventional chemo-immunotherapy (CIT) has been the long-standing option for CLL patient without TP53 disruption and different regimens have emerged depending on patient comorbidities (fludarabine-cyclophosphamide-rituximab, FCR; bendamustin-rituximab, BR; GA101-chloraminophene, G-CLB). These regimens fail to be effective in patients with TP53 disruption and alternative strategies are proposed for them. The CLL therapeutic panel is now enriched by oral kinase inhibitors targeting the B-cell receptor signaling. The Bruton's tyrosine kinase inhibitors (BTKi) have been shown to provide prolonged response, even in cases where CIT usually failed, such as patients harboring TP53 disruption. In relapsed/refractory patients, median PFS with the BTKi ibrutinib is 44 months. In the frontline setting, ibrutinib has recently been shown to result in superior PFS and less infectious complications than standard CIT regimens. The advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added another option for the treatment of CLL patients. BCL2 is an antiapoptotic molecule governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2 with venetoclax as monotherapy led to 79% response rate in the relapse/refractory setting. Combining venetoclax to rituximab demonstrated better PFS than bendamustine-rituximab in relapsed/refractory patients. However, these treatment approaches also come with new challenges that are difficult to-address in phase 3 clinical trials and that deserve larger scale studies and longer follow-up. The emergence of drug resistance, the changes of safety profiles to deal with in routine practice and the observance of these orally administered drugs are emerging as new concerns. How these compounds change the incidence of typical CLL complication such as Richter transformation, immune cytopenias and infections remains to be determined. A growing body of concerns is also raising regarding the unlimited administration of some of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use of these drugs is unknown. The advent of the BCL2 (B-cell lymphoma 2) inhibitor venetoclax has recently added another option for the treatment of CLL patients 11,12. BCL2 is an antiapoptotic molecule governing mitochondrial apoptosis and is strongly expressed in CLL cells. Inhibiting BCL2 with venetoclax as monotherapy led to 79% response rate in the relapse/refractory setting. Combining venetoclax to rituximab demonstrated better PFS than bendamustine-rituximab in relapsed/refractory patients12. However, these treatment approaches also come with new challenges that are difficult to-address in phase 3 clinical trials and that deserve larger scale studies and longer follow-up. The emergence of drug resistance, the changes of safety profiles to deal with in routine practice and the observance of these orally administered drugs are emerging as new concerns. How these compounds change the incidence of typical CLL complication such as Richter transformation, immune cytopenias and infections remains to be determined. A growing body of concerns is also raising regarding the unlimited administration of some of this the compounds (costs, resistance, tolerance). Finally, the optimal order of use of these drugs is unknown. Primary objective : Setting a prospective cohort of real-world CLL/SLL patients with symptomatic disease in order to evaluate medical practices and their change and representativity over time. Secondary objectives : Overall survival and long-term toxicity, Response and PFS at each line of therapy, Impact of therapeutic trajectories on patient outcome, Representativity of the studied population Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL NOVO	VAIDA	En recrutement IDF	04/07/2024 11:04:58	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne	Vincent LEVY, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
AP-HP - Hôpital Cochin	Lise WILLEMS, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
AP-HP - Hôpital Jean Verdier	Laurent GILARDIN	Recrutement non commencé		Contact (sur clinicalTrials)
CH DE VERSAILLES SITE ANDRE MIGNOT	Fatiha MERABET, Dr	En recrutement IDF		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AMIENS - CH Amiens Picardie Site Sud - 80054 - Amiens - France	Pierre MOREL	Recrutement non commencé		Contact (sur clinicalTrials)
Angers Chu - 49933 - Angers - France	Aline CLAVERT, MD	En recrutement		Contact (sur clinicalTrials)
ANNECY - CH Annecy Genevois - 74374 - Annecy - France	Stéphanie TARDY, MD	En recrutement		Contact (sur clinicalTrials)
APHP - Hôpital Pitié Salpêtrière - Hématologie - 75651 - Paris - France	Damien ROOS-WEIL, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
AVIGNON - Centre Hospitalier - 84000 - Avignon - France	Safia CHEBREK, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
BESANCON - Hôpital Jean Minjoz - 25000 - Besançon - France	Annie BRION, MD	Recrutement non commencé		Contact (sur clinicalTrials)
BEZIERS - Centre Hospitalier - Hématologie - 34500 - Béziers - France	Alain SAAD, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
BLOIS CH - 41000 - Blois - France	Abderrazak EL YAMANI, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Bordeaux Pessac - 33604 - Pessac - France	Marie-Sarah DILHUYDY, MD	En recrutement		Contact (sur clinicalTrials)
BOURGOUIN-JALLIEU - CH Pierre Oudot - 38300 - Bourgoin-Jallieu - France	Florence LACHENAL	Recrutement non commencé		Contact (sur clinicalTrials)
BREST - Hôpital Morvan - Hématologie Clinique - 29609 - Brest - France	Cristina BAGACEAN, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
CAEN - IHBN - Hématologie Clinique - 14033 - Caen - France	Baptiste MOISDON DELAPIERRE, Dr	En recrutement		Contact (sur clinicalTrials)
CHAMBERY - CH Métropole Savoie - 73000 - Chambéry - France	Pierre FAURIE	En recrutement		Contact (sur clinicalTrials)
Clermont-Ferrand - Chu Estaing - 63000 - Clermont-Ferrand - France	Romain Guieze, MD	En recrutement		Contact (sur clinicalTrials)
Corbeil-Essonnes - Chsf - Corbeil-Essonnes - France	Laurence SIMON, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
Dijon Chu - 21000 - Dijon - France	Philippine ROBERT	Recrutement non commencé		Contact (sur clinicalTrials)
Grenoble - CHUGA - Hématologie Clinique - 38043 - Grenoble - France	Sylvain CARRAS, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
GRENOBLE GHM - Institut Daniel Hollard - 38028 - Grenoble - France	Caroline ALGRIN, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
La Reunion - Gh Site Sud - Saint-pierre - France	Hugo LEGENDRE	En recrutement		Contact (sur clinicalTrials)
La Roche Sur Yon - Chd Vendee - 85925 - La Roche-sur-Yon - France	Komivi Agbetsivi, MD	En recrutement		Contact (sur clinicalTrials)
Le Mans CH - Le Mans - France	Kamel Laribi, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
LENS - GHT Artois - 62300 - Lens - France	Daniela ROBU	Recrutement non commencé		Contact (sur clinicalTrials)
LIBOURNE - Hôpital Robert Boulin - 33505 - Libourne - France	Diane LARA	Recrutement non commencé		Contact (sur clinicalTrials)
LILLE CHU - Hôpital Claude Huriez - 59037 - Lille - France	Morgane NUDEL	En recrutement		Contact (sur clinicalTrials)
LILLE GHICL - Hôpital Saint Vincent de Paul - 59000 - Lille - France	Bénédicte HIVERT, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
LIMOGES - CHU Dupuytren 1 - 87042 - Limoges - France	Nataliya DMYTRUC	Recrutement non commencé		Contact (sur clinicalTrials)
LYON HCL - CH Lyon Sud - 69036 - Pierre-Bénite - France	Emmanuelle FERRAND, MD	En recrutement		Contact (sur clinicalTrials)
LYON-Centre Léon Bérard - 69008 - Lyon - France	Anne-Sophie MICHALLET, MD	Recrutement non commencé		Contact (sur clinicalTrials)
METZ-THIONVILLE CHR- Hôpital de Mercy - Metz - France	Philippe CARRASSOU, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique - 34295 - Montpellier - France	Charles HERBAUX, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
MORLAIX - CH des pays de Morlaix - 29672 - Morlaix - France	Vincent REBIERE	En recrutement		Contact (sur clinicalTrials)
Mulhouse - Ghrmsa - 68100 - Mulhouse - France	Bernard DRENOU, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
NANCY - CHU Brabois - 54500 - Vandœuvre-lès-Nancy - France	Pierre FEUGIER, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
NANTES - Hôpital Hôtel Dieu - Hématologie Clinique - 44093 - Nantes - France	Anne LOK, Dr	En recrutement		Contact (sur clinicalTrials)
NIMES - CHU Caremeau - 30029 - Nîmes - France	Agathe RASCALOU-WAULTIER, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
ORLEANS - CHR - Hématologie - 44100 - Orléans - France	Omar BENBRAHIM, Dr	En recrutement		Contact (sur clinicalTrials)
Perigueux - Ch - 24000 - Périgueux - France	Claire CALMETTES	En recrutement		Contact (sur clinicalTrials)
PERPIGNAN - CH St Jean - Hématologie Clinique - 66000 - Perpignan - France	Laurence SANHES, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
QUIMPER - CH de Cornouaille - 29000 - Quimper - France	Kristell MAHE	Recrutement non commencé		Contact (sur clinicalTrials)
Reims Chu - 51092 - Reims - France	Anne QUINQUENEL, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
RENNES - CHU Pontchaillou - Hématologie Clinique - 35033 - Rennes - France	Sophie DE GUIBERT, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
RENNES - Hôpital Pontchaillou - Hématologie - 35033 - Rennes - France	Marc BERNARD, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
ROUEN - Centre Henri Becquerel - Service Hématologie Clinique - 76038 - Rouen - France	Stéphane LEPRETRE, Pr	En recrutement		Contact (sur clinicalTrials)
SAINT-BRIEUC - Hôpila Yves Le Foll - 22027 - Saint-Brieuc - France	Thomas NIVET	Recrutement non commencé		Contact (sur clinicalTrials)
ST ETIENNE - CHU et Institut De Cancérologie Lucien Neuwirth - Saint-Priest-en-Jarez - France	FRessia HONEYMAN	En recrutement		Contact (sur clinicalTrials)
Strasbourg - Icans - 67033 - Strasbourg - France	Luc FORNECKER, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Toulouse - IUCT Oncopole - Service d'Hématologie - 31059 - Toulouse - France	Loïc YSEBAERT, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
TOURS - Hôpital Bretonneau - 37000 - Tours - France	Caroline DARTIGEAS, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Troyes Ch - Troyes - France	Nadia ALI AMMAR, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
Vannes - Chba - Vannes - France	Antoine BONNET, Dr	Recrutement non commencé		Contact (sur clinicalTrials)
Villejuif Igr - Villejuif - France	David GHEZ, Dr	Recrutement non commencé		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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)

NCT05590702 - French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings (FOLLOW)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

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