Follicular Lymphoma (FL) Clinical Trial
— REALYSAOfficial title:
REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS
REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data. REALYSA is a platform perfectly set up to - Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)… - Document treatment effectiveness in real life and observance - Address socio-economical questions
| Status | Recruiting |
| Enrollment | 6000 |
| Est. completion date | November 14, 2027 |
| Est. primary completion date | November 14, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Signature of the consent form for participation in the REALYSA cohort - Aged over 18 at the time of inclusion - Diagnosed with lymphoma in the last 6 months (180 days) - Lymphoma subtype belonging to at least one of the 7 histological subtypes: diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, T-cell lymphoma, Hodgkin's lymphoma, Burkitt lymphoma Exclusion Criteria: - Anti-lymphoma treatment already received (except pre-phase: typically corticosteroids, vincristine, cyclophosphamide, etoposide, alone or in combination) - Documented HIV infection - Any other lymphoma subtype not included in the list in Appendix 1. Of note, are excluded: - Chronic lymphocytic leukemia/small lymphocytic lymphoma - Hairy cell leukemia and variant - Lymphoplasmacytic lymphoma - Waldenström macroglobulinemia - Primary DLBCL of the central nervous system (CNS) - T-cell large granular lymphocytic leukemia - Chronic lymphoproliferative disorder of NK cells - Mycosis fungoides - Sézary syndrome - Primary cutaneous T cell lymphomas (mainly diagnosed and treated by dermatologists) - Post-transplant lymphoproliferative disorders (PTLD) |
| Country | Name | City | State |
|---|---|---|---|
| France | Unité d'Hématologie Clinique, CH D'ARRAS | Arras | |
| France | Service d'Hématologie, CHU Jean Minjoz | Besançon | |
| France | Institut Bergonié | Bordeaux | |
| France | Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine | Bordeaux | |
| France | Centre Hospitalier Pierre Oudot | Bourgoin-Jallieu | |
| France | Service d'Hématologie, Institut d'Hématologie de Basse Normandie | Caen | |
| France | METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset, | Chambéry | |
| France | Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand | Clermont-Ferrand | |
| France | Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor | Créteil | |
| France | CHU Francois MITTERRAND | Dijon | |
| France | Service Hématologie, Centre Hospitalier de Dunkerque | Dunkerque | |
| France | Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard, | Grenoble | |
| France | CHD Vendée | La Roche-sur-Yon | |
| France | Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon | La Tronche | |
| France | Clinique Victor Hugo | Le Mans | |
| France | Centre hospitalier Libourne | Libourne | |
| France | Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille | Lille | |
| France | Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL | Lille | |
| France | Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN, | Limoges | |
| France | Département d'Hématologie et Oncologie, Centre Léon Bérard | Lyon | |
| France | Département d'Hématologie Clinique, Hôpital Saint-Eloi, | Montpellier | |
| France | Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER, | Mulhouse | |
| France | Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes | Nantes | |
| France | Centre Hospitalier de Niort | Niort | |
| France | Service Hématologie, Hôpital St Louis | Paris | |
| France | CHU Haut-Lévêque | Pessac | |
| France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
| France | Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers | Poitiers | |
| France | Hématologie Clinique, CHU PONTCHAILLOU | Rennes | |
| France | Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo | Roubaix | |
| France | Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL | Rouen | |
| France | Service Hématologie, CH YVES LE FOLL | Saint-Brieuc | |
| France | Service Hématologie, Institut Curie - Hôpital René HUGUENIN | Saint-Cloud | |
| France | Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | |
| France | Hôpitaux Universitaires de Strasbourg | Strasbourg | |
| France | Institut Universitaire du Cancer | Toulouse | |
| France | Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon | The Lymphoma Academic Research Organisation |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Representativeness of the included population | Study population must show a good representativeness of the source population regarding demographic or diseases characteristics, to be able to generalize our results. Indeed, the representativeness of the study population can only be evaluated in areas covered by population-based cancer registries (PBCR) by comparing cases included in the REALYSA project to incident lymphoma cases registered in the general population (PBCR of the FRANCIM network). | 5 years | |
| Other | Representativeness of the included population | Study population must show a good representativeness of the source population regarding demographic or diseases characteristics, to be able to generalize our results. Indeed, the representativeness of the study population can only be evaluated in areas covered by population-based cancer registries (PBCR) by comparing cases included in the REALYSA project to incident lymphoma cases registered in the general population (PBCR of the FRANCIM network). | 9 years | |
| Primary | Progression-Free Survival (PFS) | 5 years | ||
| Secondary | Number of patients included per month in total and according to subtype of lymphoma | 5 years | ||
| Secondary | Number of patients in each region in total and according to subtype of lymphoma | 9 years | ||
| Secondary | Progression-Free Survival (PFS) | 9 years | ||
| Secondary | Event-Free Survival (EFS) | 5 years | ||
| Secondary | Event-Free Survival (EFS) | 9 years | ||
| Secondary | Overall Survival (OS) | 5 years | ||
| Secondary | Overall Survival (OS) | 9 years | ||
| Secondary | Net Survival | 5 years | ||
| Secondary | Net Survival | 9 years | ||
| Secondary | Response rate | 5 years | ||
| Secondary | Response rate | 9 years | ||
| Secondary | Duration of response | 5 years | ||
| Secondary | Duration of response | 9 years | ||
| Secondary | Time to Next Anti-Lymphoma Treatment (TTNLT) | 5 years | ||
| Secondary | Time to Next Anti-Lymphoma Treatment (TTNLT) | 9 years | ||
| Secondary | Duration of Survival after progression | 5 years | ||
| Secondary | Duration of Survival after progression | 9 years | ||
| Secondary | Frequency of Lymphoma transformations | 5 years | ||
| Secondary | Frequency of Lymphoma transformations | 9 years | ||
| Secondary | Frequency of Second cancers | 5 years | ||
| Secondary | Frequency of Second cancers | 9 years | ||
| Secondary | Frequency of other chronic disease | 5 years | ||
| Secondary | Frequency of other chronic disease | 9 years | ||
| Secondary | Number of exposure factors | Baseline | ||
| Secondary | Number of comorbidities | Baseline |
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