Lymphoma Working Party (LWP)
Study type:
Study number:
Type of Stem Cell Treatment:
Allogeneic
Autologous
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Primary objective:
1. Trends in HSCT in relapsed / refractory DLBCL over time
a. Number of HSCT reported to the EBMT Database / Year (5 year-intervals)
b. HSCT activity / country
c. Type of HSCT (auto-HSCT vs alloSCT)
d. Tandem HSCT
i. Auto-HSCT / Auto-HSCT
ii. Auto-HSCT / RIC-Allo-HSCT
e. Stem cell source (BM vs PB vs BM + PB
f. Type of donors (HLA id sib donors / MUD / mmURD / Haplo donors)
g. Type of preparatory regimen prior to auto-HSCT
i. TBI-containing regimens
ii. Chemotherapy containing regimens (BEAM / BEAC / CBV / TEAM / Others)
h. Intensity of the conditioning regimen prior to alloSCT (RIC vs MAC as defined by EBMT)
i. Disease status at HSCT (as defined by EBMT)
2. Long term outcomes after SCT for RR DLBCL over time
a. NRM
b. Incidence of relapse
c. OS
d. PFS
e. Secondary malignancies
a. Number of HSCT reported to the EBMT Database / Year (5 year-intervals)
b. HSCT activity / country
c. Type of HSCT (auto-HSCT vs alloSCT)
d. Tandem HSCT
i. Auto-HSCT / Auto-HSCT
ii. Auto-HSCT / RIC-Allo-HSCT
e. Stem cell source (BM vs PB vs BM + PB
f. Type of donors (HLA id sib donors / MUD / mmURD / Haplo donors)
g. Type of preparatory regimen prior to auto-HSCT
i. TBI-containing regimens
ii. Chemotherapy containing regimens (BEAM / BEAC / CBV / TEAM / Others)
h. Intensity of the conditioning regimen prior to alloSCT (RIC vs MAC as defined by EBMT)
i. Disease status at HSCT (as defined by EBMT)
2. Long term outcomes after SCT for RR DLBCL over time
a. NRM
b. Incidence of relapse
c. OS
d. PFS
e. Secondary malignancies
Key inclusion criteria:
1. Adult patients (age >= 18 years at the time of SCT)
2. Diagnosis of DLBCL
3. Relapsed / refractory disease at SCT (primary induction failure/primary refractory; relapse; untreated relapse or progression; progression/progressive disease; chemorefractory relapse or progression)
4. SCT between January 1989 to December 2019 (first auto-HCT, first alloSCT, first alloSCT after auto-HCT)
2. Diagnosis of DLBCL
3. Relapsed / refractory disease at SCT (primary induction failure/primary refractory; relapse; untreated relapse or progression; progression/progressive disease; chemorefractory relapse or progression)
4. SCT between January 1989 to December 2019 (first auto-HCT, first alloSCT, first alloSCT after auto-HCT)
Country:
All EBMT member countries
Principal investigator:
Norbert Schmitz, Anna Sureda
EBMT Study coordinator:
Hervé Finel
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:
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Paris Study 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?:
Not performed because Study began before implementation of GDPR
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results