DLBCL, CAR T-cell therapy Agressive lymphoma, CAR T-cell therapy
Conditions
Interventions
Biopsies and blood samples of 24 patients
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, Aggressive B-cell lymphoma, T-cell/histiocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, EBV+ DLBCL, transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma). Eligible for CAR T-cell therapy according to criteria set by the Dutch National Tumour Board. Radiotherapy as bridging therapy administered as a multiple of 4 Gy, 2-5 x 4 Gy. Patients able to provide sufficient tumour biopsy material, following standard safety and accessibility criteria. Measurable disease, as defined by Lugano criteria Signed informed consent. Age =18 at the time of signing informed consent. Ability to comply with the protocol.
Exclusion criteria
Exclusion criteria: Patients who are not bridged with radiotherapy Patients for whom a biopsy cannot be safely performed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint: Immunological changes in tumour biopsies and their microenvironment before and after radiotherapy, including changes in antigen presentation, immune checkpoint expression, adhesion and co-stimulatory proteins, and immune cell infiltration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints: Blood dynamics of lymphocytes and their subtypes before, during, and after radiotherapy.Plasma dynamics of pro-inflammatory cytokines before, during, and after radiotherapy. | — |
Countries
Netherlands
Contacts
Public ContactA.G.H. Niezink
Universitair Medisch Centrum Groningen
Outcome results
None listed