(Diffuse) Large B-cell Lymphoma
Conditions
Brief summary
to study the expression of PD-L1 in normal tissue and lymphoma lesions before CD19- directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT scan, To study whether the amount of 89Zr-atezolizumab uptake, measured by the intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to differentiate between lymphoma activity and treatment-related inflammatory reaction (histiocytic/sarcoidlike reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal
Detailed description
To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence, To correlate the pretreatment 89Zr-atezolizumab uptake to CAR T-cell therapy related grade 1-5 adverse events (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS))., To correlate tumor 89Zr-atezolizumab uptake with tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy, To compare the 89Zr-atezolizumab distribution in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as a bridging strategy prior to CAR T-cell infusion. If possible, these results will be compared to tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy of an irradiated lymphoma lesion, To determine the incidence of a treatment-related inflammatory signal on 18F-FDGPET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to study the expression of PD-L1 in normal tissue and lymphoma lesions before CD19- directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT scan, To study whether the amount of 89Zr-atezolizumab uptake, measured by the intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to differentiate between lymphoma activity and treatment-related inflammatory reaction (histiocytic/sarcoidlike reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal | — |
Secondary
| Measure | Time frame |
|---|---|
| To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence, To correlate the pretreatment 89Zr-atezolizumab uptake to CAR T-cell therapy related grade 1-5 adverse events (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS))., To correlate tumor 89Zr-atezolizumab uptake with tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy, To compare the 89Zr-atezolizumab distribution in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as a bridging strategy prior to CAR T-cell infusion. If possible, these results will be compared to tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy of an irradiated lymphoma lesion, To determine the incidence of a treatment-related inflammatory signal on 18F-FDGPET/CT scan (histiocytic/sarcoid-like reaction) | — |
Countries
Netherlands
Outcome results
None listed