Lymphoma Working Party (LWP)
Study type:
Study number:
84032251
Type of treatment:
Autologous
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Clinical Outcomes of MCL after auto-transplant
Primary objective:
Does long-term survival outcome of MCL patients post auto-SCT improved in the
current era compared to prior periods?
To assess characteristics and survival outcomes of patients diagnosed with
MCL and underwent auto-SCT in CR1 or PR1 in the current era (2021-2024)
to be compared to prior time periods
≤2012 – Pre-maintenance
2013–2016 – Maintenance era
≥2017 – Novel agent era
current era compared to prior periods?
To assess characteristics and survival outcomes of patients diagnosed with
MCL and underwent auto-SCT in CR1 or PR1 in the current era (2021-2024)
to be compared to prior time periods
≤2012 – Pre-maintenance
2013–2016 – Maintenance era
≥2017 – Novel agent era
Key inclusion criteria:
A. Age ≥ 18 years of age at transplant
B. Diagnosis: MCL
C. First auto-SCT in CR1 or PR1
D. Year of transplant between 2010 and 2024
B. Diagnosis: MCL
C. First auto-SCT in CR1 or PR1
D. Year of transplant between 2010 and 2024
Country:
All EBMT member countries
Principal investigator:
Iman Abou Dalle
EBMT Study coordinator:
Irma Khvedelidze
Study coordinator email:
irma.khvedelidze@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
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