Lymphoma Working Party (LWP)
Study type:
Study number:
84032248
Type of treatment:
Autologous
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
Post auto-HCT relapsed MCL
Primary objective:
The main objective of this study is to assess the characteristics and outcomes
of patients with MCL relapsing after having received auto-SCT in CR or PR
with a delay between diagnosis and auto-HCT less than one year in the
current era that includes multiple novel agents and therapy modes, basically
exploring three time periods: 2011-2015; 2016-2019; 2020-2024, comparing
the characteristics of the disease, treatments utilized in addition to the
outcomes across these periods.
of patients with MCL relapsing after having received auto-SCT in CR or PR
with a delay between diagnosis and auto-HCT less than one year in the
current era that includes multiple novel agents and therapy modes, basically
exploring three time periods: 2011-2015; 2016-2019; 2020-2024, comparing
the characteristics of the disease, treatments utilized in addition to the
outcomes across these periods.
Key inclusion criteria:
- Age ≥ 18 years of age at transplant
- Diagnosis: MCL
- First auto-SCT in CR or PR with a delay between diagnosis and
autoHCT less than one year
- First relapse after first auto-SCT (tandem excluded) 2011-2024
- Diagnosis: MCL
- First auto-SCT in CR or PR with a delay between diagnosis and
autoHCT less than one year
- First relapse after first auto-SCT (tandem excluded) 2011-2024
Country:
All EBMT member countries
Principal investigator:
Dr. Nour MOUKALLED, Dr. Olivier HERMINE & Dr. Ali BAZARBACHI
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
Study Specific Questionnaire (MED-C)
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