GoCART Coalition
Type d'étude:
Numéro de l'étude:
Type de traitement à base de cellules souches:
CAR T
Maladies:
Lymphome non hodgkinien (LNH)
Titre court:
CARLAPSE
Objectif principal:
Primary objectives:
1. (Starting point: date of relapse/progression): To estimate the overall survival after a first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on survival.
Secondary objectives:
2. (Starting point: date of relapse/progression): To estimate the incidence of patients who receive salvage therapy after first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on the occurrence of salvage therapy.
3. (Starting point: date of first salvage therapy): To estimate the overall survival after first salvage treatment and to evaluate variables with an impact factor on survival, including the type of therapy.
4. (Starting point: date of first salvage therapy): To estimate the best overall response rate (ORR: CR, PR, Progression) using Lugano 2014 criteria.
5. (Starting point: date of first response to first line of salvage therapy): Duration of response (DOR) of patients who received first line salvage therapy.
6. (Starting point: date of first salvage therapy): To estimate the progression-free survival after first salvage treatment and to evaluate variables with an impact factor, including the type of therapy.
1. (Starting point: date of relapse/progression): To estimate the overall survival after a first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on survival.
Secondary objectives:
2. (Starting point: date of relapse/progression): To estimate the incidence of patients who receive salvage therapy after first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on the occurrence of salvage therapy.
3. (Starting point: date of first salvage therapy): To estimate the overall survival after first salvage treatment and to evaluate variables with an impact factor on survival, including the type of therapy.
4. (Starting point: date of first salvage therapy): To estimate the best overall response rate (ORR: CR, PR, Progression) using Lugano 2014 criteria.
5. (Starting point: date of first response to first line of salvage therapy): Duration of response (DOR) of patients who received first line salvage therapy.
6. (Starting point: date of first salvage therapy): To estimate the progression-free survival after first salvage treatment and to evaluate variables with an impact factor, including the type of therapy.
Principaux critères d'inclusion:
Adult patients at time for first CAR-T (age >18)
Year of CAR-T infusion 2018-2022
Diagnosis of DLBCL
CAR-T Kymriah or Yescarta
Experience of relapse (or continuous progression) after first CAR-T
Year of CAR-T infusion 2018-2022
Diagnosis of DLBCL
CAR-T Kymriah or Yescarta
Experience of relapse (or continuous progression) after first CAR-T
Pays:
Tous les pays membres de l'EBMT
Investigateur principal:
Alberto Mussetti
Coordinateur EBMT de l'étude:
Eva MICHEL
E-mail du coordinateur de l'étude:
eva.michel@ebmt.org
Unité d'étude EBMT:
Unité d'études de Paris
Raison du traitement des données personnelles:
Recherche et développement de procédures nouvelles et améliorées de transplantation, de thérapie cellulaire et d'immunosuppression.
Catégories de données personnelles collectées:
Date de Naissance / Année de Naissance, Genre
Données médicales déjà déclarées au registre EBMT
Questionnaire spécifique à l'étude (MED-C)
Destinataires pouvant accéder aux données:
Unité d'études de Paris
Sous-traitants tiers de données personnelles pour le compte de l'EBMT/Prestataire de services:
Oui
Privacy notices
Article 6 base légale pour le traitement des données personnelles:
Article 6.1 (a) - Consentement (Collecte)
Base de l'article 9 pour le traitement des données de catégorie spéciale:
Article 9(2) (a) - Consentement (Collecte)
Data Protection Impact Assessments
Droits accessibles aux personnes:
Accès
Portabilité des données
Rectification
Objection
Suppression
Une évaluation de l'impact (DPIA) sur la protection des données est-elle requise ?:
Analyse d'impact réalisée pour le registre EBMT (études WP & NIS)
Calendrier de conservation (si possible):
Au moins 5 ans après le rapport final ou la première publication des résultats de l'étude