Lymphoma Working Party (LWP)
Study type:
Study number:
84032241
Type of treatment:
Allogeneic
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
AlloHCT in R/R MCL
Primary objective:
The primary objective is to identify clinical and biological parameters associated with
reduced non-relapse mortality (NRM) and improved post-alloHCT outcomes in
patients with r/r MCL. This analysis aims to identify prognostic factors that may justify
earlier alloHCT consideration in selected patients, rather than limiting its use to a
last-line salvage approach after the failure of major therapeutic alternatives.
To achieve this, the analysis will focus on the following variables and their impact on
post-transplant outcomes (OS, PFS, IR, NRM):
- patient-related factors (age, prior treatments, remission status before
alloHCT)
- Disease biology and risk parameters (high-risk morphology, MIPI score)
- Transplant-specific variables (conditioning regimen, donor type, GVHD
prophylaxis)
Secondary objectives include the evaluation of post-transplant complications
including GVHD and risk of secondary malignancies.
reduced non-relapse mortality (NRM) and improved post-alloHCT outcomes in
patients with r/r MCL. This analysis aims to identify prognostic factors that may justify
earlier alloHCT consideration in selected patients, rather than limiting its use to a
last-line salvage approach after the failure of major therapeutic alternatives.
To achieve this, the analysis will focus on the following variables and their impact on
post-transplant outcomes (OS, PFS, IR, NRM):
- patient-related factors (age, prior treatments, remission status before
alloHCT)
- Disease biology and risk parameters (high-risk morphology, MIPI score)
- Transplant-specific variables (conditioning regimen, donor type, GVHD
prophylaxis)
Secondary objectives include the evaluation of post-transplant complications
including GVHD and risk of secondary malignancies.
Key inclusion criteria:
Patients with relapsed or refractory mantle cell lymphoma who have undergone
allogeneic stem cell transplantation will be included in the study.
Eligibility criteria:
a) Diagnosis of r/r mantle cell lymphoma
b) Age>= 18 years
c) 1st Allograft between Jan/2010 to Dec/2020
d) Prior anthracycline- or bendamustine containing treatment
e) Prior autograft allowed
allogeneic stem cell transplantation will be included in the study.
Eligibility criteria:
a) Diagnosis of r/r mantle cell lymphoma
b) Age>= 18 years
c) 1st Allograft between Jan/2010 to Dec/2020
d) Prior anthracycline- or bendamustine containing treatment
e) Prior autograft allowed
Country:
All EBMT member countries
Principal investigator:
Dr. Nora LIEBERS & Dr. Sascha DIETRICH
EBMT Study coordinator:
Diane Marie BACABAC
Study coordinator email:
diane.bacabac@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