GoCART Coalition
Study type:
Study number:
Type of Stem Cell Treatment:
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
CARLAPSE
Primary objective:
Primary objectives:
1. (Starting point: date of relapse/progression): To estimate the overall survival after a first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on survival.
Secondary objectives:
2. (Starting point: date of relapse/progression): To estimate the incidence of patients who receive salvage therapy after first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on the occurrence of salvage therapy.
3. (Starting point: date of first salvage therapy): To estimate the overall survival after first salvage treatment and to evaluate variables with an impact factor on survival, including the type of therapy.
4. (Starting point: date of first salvage therapy): To estimate the best overall response rate (ORR: CR, PR, Progression) using Lugano 2014 criteria.
5. (Starting point: date of first response to first line of salvage therapy): Duration of response (DOR) of patients who received first line salvage therapy.
6. (Starting point: date of first salvage therapy): To estimate the progression-free survival after first salvage treatment and to evaluate variables with an impact factor, including the type of therapy.
1. (Starting point: date of relapse/progression): To estimate the overall survival after a first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on survival.
Secondary objectives:
2. (Starting point: date of relapse/progression): To estimate the incidence of patients who receive salvage therapy after first relapse/progression post CAR-T for DLBCL and to evaluate which variables have an impact on the occurrence of salvage therapy.
3. (Starting point: date of first salvage therapy): To estimate the overall survival after first salvage treatment and to evaluate variables with an impact factor on survival, including the type of therapy.
4. (Starting point: date of first salvage therapy): To estimate the best overall response rate (ORR: CR, PR, Progression) using Lugano 2014 criteria.
5. (Starting point: date of first response to first line of salvage therapy): Duration of response (DOR) of patients who received first line salvage therapy.
6. (Starting point: date of first salvage therapy): To estimate the progression-free survival after first salvage treatment and to evaluate variables with an impact factor, including the type of therapy.
Key inclusion criteria:
Adult patients at time for first CAR-T (age >18)
Year of CAR-T infusion 2018-2022
Diagnosis of DLBCL
CAR-T Kymriah or Yescarta
Experience of relapse (or continuous progression) after first CAR-T
Year of CAR-T infusion 2018-2022
Diagnosis of DLBCL
CAR-T Kymriah or Yescarta
Experience of relapse (or continuous progression) after first CAR-T
Country:
All EBMT member countries
Principal investigator:
Alberto Mussetti
EBMT Study coordinator:
Eva MICHEL
Study coordinator email:
eva.michel@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
Study Specific Questionnaire (MED-C)
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