NL-OMON48775尚未招募2 期
Molecular imaging of zirconium-89-labeled atezolizumab as a tool to investigate atezolizumab biodistribution in diffuse large B-cell lymphoma - PDL1 imaging in DLBC
HOVO0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 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
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria, • Age 18-75 (inclusive) years
- •Patients with a confirmed histologic diagnosis of diffuse large B-cell
- •lymphoma (DLBCL-NOS)
- •based upon a representative histology specimen according to the WHO
- •classification, revision 2016
- •(see appendix A)
- •Ann Arbor stages II-IV
- •Negative pregnancy test at study entry
- •Patient is willing and able use adequate contraception during and until 5
- •months after the last
- •protocol treatment.
- •Written informed consent
- •Patient is capable of giving a written informed consent
排除标准
- •All histopathological diagnoses other than DLBCL-NOS according to the WHO
- •classification, revision 2016, including:
- •- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6
- •translocations
- •- Testicular large B-cell lymphoma
- •- Primary mediastinal B cell lymphoma
- •- Transformed indolent lymphoma
- •- Post-transplant lymphoproliferative disorder, Organ dysfunction
- •Clinical signs of severe pulmonary dysfunction
- •Clinical signs of heart failure (NYHA classification II-IV)
- •Symptomatic coronary artery disease or cardiac arrhythmias not well
- •controlled with medication.
- •Myocardial infarction during the last 6 months
- •Significant renal dysfunction (serum creatinine >= 150 umol/l or clearance <=
- •Creatinine clearance may be calculated by Cockcroft -Gault formula:
- •CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females) /
- •(0.815 x serum creatinine [µmol/L])
- •Inadequate hematological function: hemoglobin < 5.5 mmol/L ANC <
- •1.0x10^9/L or platelets < 75x10^9 /L
- •Spontaneous INR > 1.5, aPTT >33
- •Significant hepatic dysfunction (total bilirubin >= 1.5x upper limit of normal
- •(ULN) or transaminases >= 2.5 x ULN), unless related to Gilberts syndrome.
- •Clinical signs of severe cerebral dysfunction
- •Patients with a history of uncontrolled seizures, central nervous system
- •disorders or psychiatric disability judged by the investigator to be clinically
- •significant and adversely affecting compliance to study drugs
- •Major surgery within the last 4 weeks, Known or suspected infection
- •Known active bacterial, viral, fungal, mycobacterial, parasitic, or other
- •infection or any major episode of infection requiring treatment with IV
- •antibiotics or hospitalization within 4 weeks before date of registration.
- •Suspected active or latent tuberculosis needs to be confirmed by positive
- •interferon gamma (IFN-γ) release assay
- •Patients known to be HIV-positive
- •Active chronic hepatitis B or C infection
- •Administration of a live, attenuated vaccine within 4 weeks before date of
- •registration or anticipation that such a live attenuated vaccine will be
- •required during the study and for a period of 5 months after discontinuation of
- •atezolizumab., Auto-immune
- •Any active or history of documented autoimmune disease, including but not
- •limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
- •erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular
- •thrombosis associated with antiphospholipid syndrome, Wegener*s granulomatosis,
- •Sjögren*s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or
- •glomerulonephritis.
- •The following exceptions are allowed: Patients with autoimmune-related
- •hypothyroidism or type 1 diabetes mellitus who are on stable treatment.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
- •bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or
- •evidence of active pneumonitis per chest CT scan at screening.
- •Patients with uncontrolled asthma or allergy, requiring systemic steroid
- 另有 4 项未显示
研究者
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