Chronic Malignancies Working Party (CMWP)
Type d'étude:
Numéro de l'étude:
Type de traitement:
Allogeneic
Maladies:
Chronic Lymphocytic Leukaemia (CLL)
Titre court:
Objectif principal:
AlloSCT after Multiple Pathway Inhibitors:
We hypothesize that many nowadays transplanted patients for CLL have been pretreated with at least two pathway inhibitors (PI). The aim of this study is to describe the outcome of alloSCT of these patients in terms of PFS, OS, cumulative incidence of relapse (CIR) and NRM.
AlloSCT after stopping Ibrutinib for intolerance or relapse:
The aim of this study is to describe the outcome of alloSCT in CLL patients that were transplanted after Ibrutinib cessation in terms of PFS, OS, CIR and NRM.
Venetoclax before and after alloSCT for CLL:
Venetoclax is currently more and more widely used for relapsed CLL. Data on the use of Venetoclax before alloSCT or after alloSCT in the event of relapse or persistence of a detectable residual disease are lacking. The aim of this study is to describe the outcome of alloSCT in CLL patients that were transplanted after venetoclax use and/or treated with venetoclax after alloSCT in terms of PFS, OS, CIR and NRM and the response rate, PFS and OS in case venetoclax was given after alloSCT .
We hypothesize that many nowadays transplanted patients for CLL have been pretreated with at least two pathway inhibitors (PI). The aim of this study is to describe the outcome of alloSCT of these patients in terms of PFS, OS, cumulative incidence of relapse (CIR) and NRM.
AlloSCT after stopping Ibrutinib for intolerance or relapse:
The aim of this study is to describe the outcome of alloSCT in CLL patients that were transplanted after Ibrutinib cessation in terms of PFS, OS, CIR and NRM.
Venetoclax before and after alloSCT for CLL:
Venetoclax is currently more and more widely used for relapsed CLL. Data on the use of Venetoclax before alloSCT or after alloSCT in the event of relapse or persistence of a detectable residual disease are lacking. The aim of this study is to describe the outcome of alloSCT in CLL patients that were transplanted after venetoclax use and/or treated with venetoclax after alloSCT in terms of PFS, OS, CIR and NRM and the response rate, PFS and OS in case venetoclax was given after alloSCT .
Principaux critères d'inclusion:
o Patients diagnosed with Chronic Lymphocytic Leukemia.
o Received Allogeneic HSCT between 2015 and 2020.
o No Richter’s transformation before first allogeneic HSCT.
o No previous autologous HSCT before first allogeneic HSCT
o Adults (≥18 years).
o Received Allogeneic HSCT between 2015 and 2020.
o No Richter’s transformation before first allogeneic HSCT.
o No previous autologous HSCT before first allogeneic HSCT
o Adults (≥18 years).
Pays:
Tous les pays membres de l'EBMT
Investigateur principal:
Olivier Tournilhac, Michel van Gelder
Coordinateur EBMT de l'étude:
Joe Tuffnell
E-mail du coordinateur de l'étude:
cmwp@ebmt.org
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 Leiden
Unité statistique
Sous-traitants tiers de données personnelles pour le compte de l'EBMT/Prestataire de services:
Non
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)
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