Lymphoma Working Party (LWP)
Study type:
Study number:
84032226
Type of treatment:
Autologous
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
CAR T vs. Autologous HSCT for LBCL in CR
Primary objective:
To evaluate progression-free survival at one year in LBCL patients in CR treated
with CAR T-cell therapy compared to auto-HSCT.
with CAR T-cell therapy compared to auto-HSCT.
Key inclusion criteria:
Age: 18-80 years
Diagnosis: all subtypes of large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL), NOS
B-cell lymphoma, unclassifiable, diffuse large B-cell and classical
Hodgkin (Gray zone lymphoma)
B-cell lymphoma, unclassifiable, diffuse large B-cell lymphoma and
Burkitt lymphoma (Intermediate DLBCL/BL)
Primary mediastinal large B-cell lymphoma (PMBCL)
T-cell/histiocyte rich large B cell lymphoma
EBV positive DLBCL, NOS
ALK positive large B-cell lymphoma - - - -
High grade B-cell lymphoma NOS
DLBCL associated with chronic inflammation
Primary cutaneous DLBCL, leg type
Germinal center B-cell type (GCB) DLBCL
HHV8 positive DLBCL, NOS
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Activated B-cell type (ABC or non-GCB) DLBCL
Received commercial anti-CD19 CAR T-cell therapy (axi-cel, liso
cel, or tisa-cel) or auto-HSCT between January 1, 2019, and
December 31, 2022
Patient in complete remission at the time of CAR T-cell therapy or
auto-HSCT
Diagnosis: all subtypes of large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL), NOS
B-cell lymphoma, unclassifiable, diffuse large B-cell and classical
Hodgkin (Gray zone lymphoma)
B-cell lymphoma, unclassifiable, diffuse large B-cell lymphoma and
Burkitt lymphoma (Intermediate DLBCL/BL)
Primary mediastinal large B-cell lymphoma (PMBCL)
T-cell/histiocyte rich large B cell lymphoma
EBV positive DLBCL, NOS
ALK positive large B-cell lymphoma - - - -
High grade B-cell lymphoma NOS
DLBCL associated with chronic inflammation
Primary cutaneous DLBCL, leg type
Germinal center B-cell type (GCB) DLBCL
HHV8 positive DLBCL, NOS
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Activated B-cell type (ABC or non-GCB) DLBCL
Received commercial anti-CD19 CAR T-cell therapy (axi-cel, liso
cel, or tisa-cel) or auto-HSCT between January 1, 2019, and
December 31, 2022
Patient in complete remission at the time of CAR T-cell therapy or
auto-HSCT
Country:
All EBMT member countries
Principal investigator:
Dr. Remy DULERY
EBMT Study coordinator:
Diane Marie BACABAC
Study coordinator email:
diane.bacabac@ebmt.org
EBMT Study Unit:
Paris Study Unit
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
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