Hodgkin lymphoma
Conditions
Interventions
nvt
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • All patients with histologically proven CD30-positive (i.e. > 1% cells) lymphomas who will be treated with brentuximab vedotin, including: o Hodgkin lymphoma o T-cell lymphoma o Cutaneous T-cell lymphoma o DLBCL • Age >=18 • Signed written informed consent form (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures • Measurable disease: on CT scan at least 1 lesion/node with a long axis of > 1.5 cm and at least one positive lesion on 18F-FDG PET scan * • WHO performance status 0-2 (see appendix A) * • Adequate hepatic function: total bilirubin = 1.5 x 109/L and platelet count >=100 x 109/L, unless caused by diffuse bone marrow infiltration by lymphoma • Hemoglobin must be >= 8 g/dL (5.0 mmol/L), transfusion is allowed * • Life expectancy of >3 months with treatment * • Negative pregnancy test at study entry, if applicable
Exclusion criteria
Exclusion criteria: • Prior allergic reaction or known hypersensitivity to immunoglobulins, recombinant proteins, murine proteins, or to any excipient contained in the dug formulation of brentuximab vedotin • Peripheral sensory or motor neuropathy grade >= 2 * • Patients with a serious psychiatric disorder that could, in the investigator's opinion, potentially *interfere with the completion of treatment according to protocol * • Patients who have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule • Claustrophobia to the extent that PET-CT is impossible • Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • A feasible and optimized 89Zr-brentuximab imaging protocol in patients with CD30+ lymphomas • Safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of the tracer 89Zr-brentuximab • The relationship between 89Zr-brentuximab biodistribution (tumor uptake) and CD30 protein expression (IHC), soluble CD30 measurements (ELISA), as well as CD30 RNA expression (nanostring). | — |
Secondary
| Measure | Time frame |
|---|---|
| • The extent of heterogeneity in 89Zr-brentuximab uptake compared to 18F-FDG-PET and the potential correlation with response to therapy (as determined via 18F-FDG PET/CT per the International Working Group criteria (1,2). • Drug delivery to tumor lesions through IHC (using anti MMAE mAbs) on biopsies taken during or directly after treatment with brentuximab vedotin and its relationship with 89Zr-brentuximab tracer uptake (in CTCL, MF patients only). | — |
Countries
Netherlands
Outcome results
None listed