EUCTR2015-004741-54-IT进行中（未招募）1 期
A phase 2 study of brentuximab vedotin in combination with standard of care treatment (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [RCHOP]) or RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) as front-line therapy in patients with diffuse large B-cell lymphoma (DLBCL) - Study of brentuximab vedotin combined with RCHOP or RCHP for front-line treatment of patients with d
SEATTLE GENETICS, INC.0 个研究点目标入组 50 人开始时间: 2018年4月20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
- 50
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.Treatment-naive patients with systemic de novo or transformed DLBCL, or follicular NHL grade 3b; patients must have high-intermediate or high risk disease based on standard IPI (score =3 for patients >60 years of age) or aaIPI (score 2 or 3 for patients =60 years of age), and stage IAX (bulk defined as single lymph node mass >10 cm in diameter), IB–IV disease
- •2.Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist
- •3.An Eastern Cooperative Oncology Group (ECOG) performance status =2
- •4.Age 18 years or older
- •5.Patients must have the following baseline laboratory data:
- •?bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert's disease or documented hepatic involvement with lymphoma
- •?alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3X ULN or =5X ULN for patients with documented hepatic involvement with lymphoma
- •?serum creatinine =2X ULN
- •?absolute neutrophil count (ANC) =1000/µL (unless documented bone marrow involvement with lymphoma)
- •?platelet count =50,000/µL (unless documented bone marrow involvement with lymphoma)
- •6.Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are post menopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy.
- •7.Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraception methods during the study and for 12 months following the last dose of study drug
- •8.Patients or their legally authorized representative must provide written informed consent
- •9.Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Previous history of treated indolent lymphoma. Newly diagnosed patients with DLBCL who are found to have small cell infiltration of the bone marrow or other diagnostic material (representing a discordant lymphoma) are eligible.
- •2.History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
- •3.History of progressive multifocal leukoencephalopathy (PML)
- •4.Cerebral/meningeal disease related to the underlying malignancy
- •5.Baseline peripheral neuropathy >/= Grade 2 (per the National Cancer Institute’s Common Terminology Criteria for Adverse Events [NCI CTCAE], Version 4.03) or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
- •6.Left ventricular ejection fraction less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months or previous treatment with complete cumulative doses of doxorubicin or other anthracyclines
- •7.Any active Grade 3 or higher (per the NCI CTCAE, Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
- •8.Current therapy with other systemic anti-neoplastic or investigational agents
- •9.Females who are breastfeeding
- •10.Known hypersensitivity to any excipient contained in any of the drug formulations of study treatments
- •11.Patients with known urinary outflow obstruction
- •12.Known human immunodeficiency virus (HIV) infection or known or suspected active hepatitis C infection. Patients with a positive hepatitis B polymerase chain reaction (PCR) assay who have also tested positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody; patients with a negative PCR assay are permitted with effective anti-viral prophylaxis.
研究者
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