GoCART Coalition
Study type:
Study number:
Type of Stem Cell Treatment:
CAR T
Diseases:
Acute Lymphatic Leukaemia (ALL)
Short title:
B-ALL
Primary objective:
Before CART
1. Primary Aim: To evaluate the impact of previous HCT and preceding therapy on the complete remission incidence (haematological and molecular) post CART19.
2. Secondary Aims:
2a. To assess the impact of preceding therapy on the tumour burden prior CART19 (tumour burden at time of infusion)
2b. To assess the impact of prior preceding therapy on the overall survival (OS), relapse incidence (RI), non-relapse mortality (NRM) and functional persistence of CART19 post CART19
After CART
3. Primary Aim: To evaluate the impact of consolidative allo-HCT on LFS post CR following a CART19
4. Secondary Aim: To assess the impact of consolidative allo-HCT on the OS, RI and NRM post CR post CART19
1. Primary Aim: To evaluate the impact of previous HCT and preceding therapy on the complete remission incidence (haematological and molecular) post CART19.
2. Secondary Aims:
2a. To assess the impact of preceding therapy on the tumour burden prior CART19 (tumour burden at time of infusion)
2b. To assess the impact of prior preceding therapy on the overall survival (OS), relapse incidence (RI), non-relapse mortality (NRM) and functional persistence of CART19 post CART19
After CART
3. Primary Aim: To evaluate the impact of consolidative allo-HCT on LFS post CR following a CART19
4. Secondary Aim: To assess the impact of consolidative allo-HCT on the OS, RI and NRM post CR post CART19
Key inclusion criteria:
Patients receiving a CART19 for a B-ALL
2CART received between 2015 and 2022 (according to the 1y follow-up embargo for publication).
Patients in hematological CR post CART19
2CART received between 2015 and 2022 (according to the 1y follow-up embargo for publication).
Patients in hematological CR post CART19
Country:
All EBMT member countries
Principal investigator:
ValentÃn ORTIZ-MALDONADO
EBMT Study coordinator:
Eva MICHEL
Study coordinator email:
eva.michel@ebmt.org
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?:
Not performed because Study began before implementation of GDPR
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results