NL-OMON51758尚未招募不适用
Molecular Imaging of Zirconium-89-labeled Brentuximab as a Tool to Investigate brentuximab biodistribution in CD30-positive Lymphoma - CD30 Imaging in DLBC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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
排除标准
- •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
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