REal World Data in LYmphoma and Survival in Adults

Recruiting

• Conditions: Diffuse Large B Lymphoma (DLBCL); Mantle Cell Lymphoma (MCL); Marginal Zone Lymphoma (MZL); T-cell Lymphoma (T-NHL); Burkitt Lymphoma (BL)); Follicular Lymphoma (FL); Hodgkin's Lymphoma (HL)

• Registration Number: NCT03869619
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study Start: 2018-11-14
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28
• Primary Completion: 2027-11-14
• Study Completion: 2027-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	5 years

Secondary Outcome Measures

Name	Time	Method
Frequency of Second cancers	9 years
Frequency of other chronic disease	9 years
Net Survival	9 years
Response rate	9 years
Duration of response	9 years
Number of patients included per month in total and according to subtype of lymphoma	5 years
Number of patients in each region in total and according to subtype of lymphoma	9 years
Progression-Free Survival (PFS)	9 years
Event-Free Survival (EFS)	9 years
Overall Survival (OS)	9 years
Duration of Survival after progression	9 years
Time to Next Anti-Lymphoma Treatment (TTNLT)	9 years
Number of exposure factors	Baseline
Number of comorbidities	Baseline
Frequency of Lymphoma transformations	9 years

Trial Locations

Locations (37)

Unité d'Hématologie Clinique, CH D'ARRAS; 🇫🇷 Arras, France

Service d'Hématologie, CHU Jean Minjoz; 🇫🇷 Besançon, France

Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Institut Bergonié; 🇫🇷 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

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