Lymphoma Working Party (LWP)
Study type:
Study number:
84032222
Type of treatment:
Allogeneic
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
The choice of conditioning regimen in coutaneous T Cell Lymphoma
Primary objective:
Assess which conditioning regimen is associated with most optimal outcomes of
alloSCT in terms of Overall Survival, Progression Free survival, Transplant related
mortality and Graft versus Host Disease free Survival, in CTCL
Compare Myeloablative conditioning and Reduced intensity conditioning regimens
Compare TBI-containing vs. non-TBI conditioning regimens
Compare PTCy-based vs. non-PTCy GVHD prophylaxis outcomes
alloSCT in terms of Overall Survival, Progression Free survival, Transplant related
mortality and Graft versus Host Disease free Survival, in CTCL
Compare Myeloablative conditioning and Reduced intensity conditioning regimens
Compare TBI-containing vs. non-TBI conditioning regimens
Compare PTCy-based vs. non-PTCy GVHD prophylaxis outcomes
Key inclusion criteria:
• >=18 years old
• Diagnosis of CTCL/MF/SS treated with alloSCT
• T-cell replete alloSCT from a matched sibling donor, unrelated
donor, haploidentical donor or umbilical cord blood donor
• AlloSCT performed within the past 14 years (2008-2022),
categorized into 5-year intervals (2008-2013, 2014-2018, 2019-
2022)
• Diagnosis of CTCL/MF/SS treated with alloSCT
• T-cell replete alloSCT from a matched sibling donor, unrelated
donor, haploidentical donor or umbilical cord blood donor
• AlloSCT performed within the past 14 years (2008-2022),
categorized into 5-year intervals (2008-2013, 2014-2018, 2019-
2022)
Country:
All EBMT member countries
Principal investigator:
Dr. Federico MAZZON
EBMT Study coordinator:
Diane Marie BACABAC
Study coordinator email:
diane.bacabac@ebmt.org
EBMT Study Unit:
Paris Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Recipients who may access the data:
Paris 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)
Data Protection Impact Assessments
Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
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