GoCART Coalition
Study type:
Study number:
Type of treatment:
CAR T
Diseases:
Non-Hodgkin’s Lymphoma (NHL)
Short title:
BCDI
Primary objective:
1. To compare Overall Survival (OS) after CD19 CAR T therapy in patients pre-treated with BCDI to OS in patients naïve to BCDI
2. To compare Progression-free Survival (PFS), Relapse Incidence (RI) and Non-Relapse Mortality (NRM) after CD19 CAR T therapy in patients pre-treated with BCDI** to patients naïve to BCDI
3. To compare incidence of Partial and/or Complete Remission (Overall response rate and complete response rate) after CD19 CAR T therapy in patients pre-treated with BCDI** to patients naïve to BCDI
4. To identify risk factors of outcomes after CD19 CAR T therapy in patients pre-treated with BCDI**
5. To assess and compare the incidence and severity of Cytokine-Release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) after CD19 CAR T therapy in patients pre-treated with BCDI** and patients naïve to BCDI
2. To compare Progression-free Survival (PFS), Relapse Incidence (RI) and Non-Relapse Mortality (NRM) after CD19 CAR T therapy in patients pre-treated with BCDI** to patients naïve to BCDI
3. To compare incidence of Partial and/or Complete Remission (Overall response rate and complete response rate) after CD19 CAR T therapy in patients pre-treated with BCDI** to patients naïve to BCDI
4. To identify risk factors of outcomes after CD19 CAR T therapy in patients pre-treated with BCDI**
5. To assess and compare the incidence and severity of Cytokine-Release syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) after CD19 CAR T therapy in patients pre-treated with BCDI** and patients naïve to BCDI
Key inclusion criteria:
- Patients aged 18 years or above at time of CAR-T cell infusion
- Diagnosis of DLBCL, HGBCL, PMBCL, T-cell/histiocyte rich LBCL
- First chronological CART infusion before July 2023
- Diagnosis of DLBCL, HGBCL, PMBCL, T-cell/histiocyte rich LBCL
- First chronological CART infusion before July 2023
Country:
All EBMT member countries
Principal investigator:
Jan Schroeder
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 applicable to surveys
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results