R1979-ONC-2090 Outcomes in Patients with Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated with Systemic Therapy from Real-World Experience
Objectif(s) de la recherche et intérêt pour la santé publique
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
This project aims to describe real-world outcomes in patients with diffuse large B-cell lymphoma who initiate currently available systematic therapies and have been relapsed and/or refractory to at least 2 qualifying lines of therapy. Outcomes of patients in the real-world will be compared to those of patients in a global, Phase 2 single arm open label trial (R1979-ONC-1625; EudraCT Number 2017-002139-41, NCT03888105) currently ongoing. This project will contextualize the results of this single-arm trial using real-world controls. As such, the research aims to assist in bringing a new, effective treatment onto market for a patient population that currently lacks sufficient treatment options.
Données utilisées
Catégories de données utilisées
Source de données utilisées
Variables sensibles utilisées
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Représentant du responsable de traitement 1
Responsable(s) de mise en oeuvre non cités comme responsable de traitement
Responsable de mise en oeuvre non cité comme responsable de traitement 1
Responsable de mise en oeuvre non cité comme responsable de traitement 2
Calendrier du projet
Base légale pour accéder aux données
Durée de conservation aux fins du projet (en années)
25
Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
Regeneron has implemented the European Commission’s Standard Contractual Clauses which require all parties to protect personal data in accordance with European Union data protection laws.
Droits des personnes
Under the terms of Articles 15-20 of the GDPR, patients whose data is used during the study may at any time contact a study site via mail, email, phone call, or any other reasonable means (e.g. during a routine visit to clinic) to exercise the following rights: data subject information, access and portability, rectification and deletion, and objection and limitation of processing. As a research exemption to individual patient consent is being followed on the basis of the significant scientific interest of this study (GDPR Article 9.2(j)), study sites will be provided a patient information notice to distribute that describes all information that patients may need about the Study, including information on how their personal data, particularly health data, will be used or transmitted to third parties during the Study and after completion, and contact details for the site, so that they can exercise the their rights under Articles 15-20 of the GDPR.