NL-OMON52540招募中2 期
A phase II study evaluating the feasibility and clinical efficacy of atezolizumab consolidation treatment in high risk diffuse large B-cell lymphoma - HOVON 151 NH
HOVO0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
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
- •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
- •Ann Arbor stages II-IV
- •WHO performance status 0 - 1
- •IPI >=3 at diagnosis
- •Complete metabolic remission (Deauville 1-3) after 6-8 cycles of R-CHOP
- •according to the Lugano criteria
- •Negative pregnancy test at study entry
- •Patient is willing and able to use adequate contraception during and until 5
- •months after the last protocol treatment.
- •Written informed consent
- •Patient is capable of giving 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 a double/triple translocation with MYC, BCL2
- •and/or BCL6. Please note that patients with an isolated MYC translocation or an
- •isolated BCL2 translocation or an isolated BCL-6 translocation are eligible
- •(single hit translocation).
- •- 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:
- •Inadequate hematological function: hemoglobin 5.5 < mmol/L, ANC < 1.0x109/L
- •or platelets < 75x109 /L
- •Signs or know history of bleeding disorder
- •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
- •regsitration 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.,
- 另有 5 项未显示
研究者
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