This study has been transitioned to CTIS with ID 2024-511151-18-00 check the CTIS register for the current data. • Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• 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 outcome
• 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).
Background summary
In this imaging study the biodistribution of brentuximab will be investigated
by using Zirconium-89 (89Zr)-labeled brentuximab. 89Zr-brentuximab imaging will
help to assess tumor uptake and pharmacokinetic and -dynamic properties of
brentuximab in patients who are intended to be treated with brentuximab
vedotin, either in one of the registered indications (HL, CTCL and sALCL) or as
part of the HOVON 136 trial for patients with DLBCL. We hypothesize that the
results of this imaging study might be used to facilitate the identification of
patients that would benefit most from brentuximab vedotin treatment
Study objective
This study has been transitioned to CTIS with ID 2024-511151-18-00 check the CTIS register for the current data.
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow
assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target
lesions or -organs.
• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of
the new tracer 89Zr-brentuximab
Secondary objectives:
• Explore the differences in biodistribution of 89Zr-brentuximab across
lymphoma subtypes.
• Compare 89Zr-brentuximab biodistribution (tumor uptake) to computer assisted
CD30 scoring on immunohistochemistry (IHC), soluble CD30 measurements (ELISA),
and CD30 RNA gene expression.
• Explore the relation between the heterogeneity in 89Zr-brentuximab uptake and
18F-FDG biodistribution as well as response to therapy (as determined via
18F-FDG PET/CT per the International Working Group criteria (1,2);
Study design
Prospective, single center, investigator sponsored trial (IST)
Intervention
nvt
Study burden and risks
We do not expect imaging procedures to interfere with patient
extend of the treatment. The participation in the imaging trial will not affect
the choice burden and risks of treatment. Patients with a relapsed DBLCL
are treated within the associated with HOVON 136 trial, while all other
patients are treated according to participation standard of care. Because of
the minimal modifications accompanying the labeling process of brentuximab the
toxicity profile of 89Zr- brentuximab is expected to be similar to that of
brentuximab. However, 89Zr-brentuximab is unlikely to pose a toxicological
threat, because the tracer is administered in a non-therapeutic dose of
maximum 50 mg.
Hanzeplein 1
groningen 9713 GZ
NL
Hanzeplein 1
groningen 9713 GZ
NL
Listed location countries
Age
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 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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511151-18-00 |
| EU-CTR | CTIS2024-511151-18-01 |
| EudraCT | EUCTR2021-005950-27-NL |
| CCMO | NL80023.042.21 |