Chronic Malignancies Working Party (CMWP)
Study type:
Study number:
Type of treatment:
Allogeneic
Diseases:
Chronic Lymphocytic Leukaemia (CLL)
Short title:
Primary objective:
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 .
Key inclusion criteria:
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).
Country:
All EBMT member countries
Principal investigator:
Olivier Tournilhac, Michel van Gelder
EBMT Study coordinator:
Joe Tuffnell
Study coordinator email:
cmwp@ebmt.org
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No
Privacy notices
Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results