Lymphoma Working Party (LWP)
Study type:
Study number:
2021-R-06
Type of Stem Cell Treatment:
Allogeneic
CAR T
Diseases:
Chronic Myeloid Lymphoma (CML)
Short title:
ZUMA allo MCL
Primary objective:
The primary objective is to compare the overall survival of patients with relapsed or refractory MCL
who have undergone CAR T cell therapy in the prospective ZUMA-2 study with MCL patients who
received an alloSCT from a matched related or unrelated donor and were registered to the EBMT
database
who have undergone CAR T cell therapy in the prospective ZUMA-2 study with MCL patients who
received an alloSCT from a matched related or unrelated donor and were registered to the EBMT
database
Key inclusion criteria:
Patients with relapsed or refractory mantle cell lymphoma who have
undergone allogeneic stem cell transplantation from a matched related or
unrelated donor will be included in the study to compare their outcomes
with MCL patients treated in the prospective ZUMA-2 study. A group of
patients matched for baseline covariates who underwent allogeneic stem
cell transplantation (alloSCT) from a matched related or unrelated donor will
be identified and compared to patients with MCL treated in the ZUMA-2
study.
undergone allogeneic stem cell transplantation from a matched related or
unrelated donor will be included in the study to compare their outcomes
with MCL patients treated in the prospective ZUMA-2 study. A group of
patients matched for baseline covariates who underwent allogeneic stem
cell transplantation (alloSCT) from a matched related or unrelated donor will
be identified and compared to patients with MCL treated in the ZUMA-2
study.
Country:
All EBMT member countries
Principal investigator:
Prof. Dr. Sascha Dietrich, Dr. Nora Liebers
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
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?:
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