EUCTR2016-001058-16-DK进行中（未招募）1 期
A Phase II Trial of Idelalisib in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma. - ILIAD
ordic Lymphoma Group0 个研究点目标入组 36 人开始时间: 2017年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Age >18 years.
- •2.Histologically confirmed diffuse large B-cell lymphoma (DLBCL) , including transformed low grade lymphoma, with either:
- •a.Refractory disease: defined as disease progression while receiving their most recent prior cytotoxic chemotherapy
- •(single-agent immunotherapy as maintenance is not considered cytotoxic therapy).
- •b.Persistent disease: defined as stable disease or partial response at the completion of their most recent prior cytotoxic chemotherapy.
- •c.Relapsed/recurrent disease: defined as complete response at the end of their most recent prior cytotoxic chemotherapy with
- •subsequent relapse or disease recurrence.
- •3.Subjects must have received prior rituximab and may have received up to 5 prior regimens containing cytotoxic chemotherapies.
- •4.Subjects must not be candidates for high-dose chemotherapy with autologous stem cell support (ASCT), due to one or more of
- •the following factors: relapse after high dose chemotherapy, age, comorbid disease, performance status, or persisting toxicities from prior
- •chemotherapy.
- •5.Absolute neutrophil count (ANC) >1.0 x 109/L, unless related to bone marrow infiltration.
- •6.At least 1 measurable disease lesion that is >1.0 cm in 2 perpendicular dimensions, with the product diameter >2.25 cm2 by
- •computed tomography (CT) or magnetic resonance imaging (MRI).
- •7.Negative serum pregnancy test within 1 week before first treatment if the subject is a woman of childbearing potential. A woman
- •of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- •8.WHO performance status 0 – 3.
- •9.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1.Prior allogeneic hematopoietic stem cell transplant (HSCT).
- •2.Prior treatment with PI3K inhibitors.
- •3.Serum total bilirubin = 1.5 x ULN (unless elevated due to Gilbert’s syndrome).
- •4.Serum ALT and AST ? 2.5 x ULN.
- •5.Estimated Creatinine Clearance < 10 ml/min.
- •6.Known seropositivity for human immunodeficiency virus (HIV).
- •7.Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease,
- •non- alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver
- •or portal hypertension.
- •8.Known history of drug induced pneumonitis.
- •9.On-going inflammatory bowel disease.
- •10.Evidence of serious active infection (eg, requiring an intravenous [IV] antibiotic, antiviral, or antifungal agent), or subjects with a
- •recent history of deep tissue infections such as fascitis or osteomyelitis.
- •11.Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices
- •<10 days before first dose of investigational product in this study. Subjects receiving high doses of corticosteroids must have been
- •tapered to a stable dose
- •at least 7 days before the first dose of investigational product.
- •12.Pregnant or breastfeeding women.
- •13.Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
- •14.Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
- •15.Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous
- •malignancies are eligible provided that they have been disease free for >2 years.
- •16.Previous myocardial infarction or pulmonary hypertension <6 months before first dose of investigational product.
- •17.History of clinically significant ventricular arrhythmia, prolonged QTc interval or unexplained syncope.
- •18.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
研究者
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