Molecular Imaging of Zirconium-89-labeled Brentuximab as a Tool to Investigate brentuximab biodistribution in CD30-positive Lymphoma
- Conditions
- Hodgkin lymphoma10025319
- Registration Number
- NL-OMON51758
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
• 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 times ULN (unless due to
lymphoma involvement of the liver or a known history of Gilbert's syndrome as
defined by > 80% unconjugated bilirubin) and ALAT/ASAT <= 3 times ULN (unless
due to lymphoma involvement of the liver; in that case ALAT/ASAT may be
elevated up to 5 times ULN)
• Adequate renal function: GFR > 50 ml/min as estimated by the
Cockroft&Gault formula at rehydration:
CrCL = (140-age [in years] x weight [kg] (x 0.85 for females)
(0.815 x serum creatinine [µmol/L]) *
• Adequate bone marrow function: Absolute neutrophil count (ANC) >= 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• A feasible and optimized 89Zr-brentuximab imaging protocol in patients with<br /><br>CD30+ lymphomas<br /><br>• Safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of the<br /><br>tracer 89Zr-brentuximab<br /><br>• The relationship between 89Zr-brentuximab biodistribution (tumor uptake) and<br /><br>CD30 protein expression (IHC), soluble CD30 measurements (ELISA), as well as<br /><br>CD30 RNA expression (nanostring).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• The extent of heterogeneity in 89Zr-brentuximab uptake compared to<br /><br>18F-FDG-PET and the potential correlation with response to therapy (as<br /><br>determined via 18F-FDG PET/CT per the International Working Group criteria<br /><br>(1,2).<br /><br>• Drug delivery to tumor lesions through IHC (using anti MMAE mAbs) on biopsies<br /><br>taken during or directly after treatment with brentuximab vedotin and its<br /><br>relationship with 89Zr-brentuximab tracer uptake (in CTCL, MF patients only).</p><br>