EUCTR2013-004109-24-IT进行中（未招募）1 期
A phase II study of Brentuximab Vedotin (BV) in the treatment of elderly Hodgkin lymphoma (HL) patients at first relapse or with primary refractory disease - FIL_BVHD01
Fondazione Italiana Linfomi Onlus0 个研究点目标入组 20 人开始时间: 2014年3月17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
- 20
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) Histologically confirmed CD30-positive disease 2) Elderly patients at first relapse or with primary refractory HL (i.e. patients who have previously received only 1 line of treatment. 3) Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents greater than 5 half-lives of the last dose of that prior treatment prior to the first dose of BV and must have fully recovered from the acute toxic effects prior to entering this study. 4) Age greater than or equal to 60 years. 5) Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT. 6) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7) The following required baseline laboratory data: absolute neutrophil count (ANC) =1500/µL, unless known marrow involvement due to disease, platelets =75,000/µL, unless known marrow involvement due to disease, bilirubin =1.5X upper limit of normal (ULN) or =3X ULN for patients with Gilbert’s disease, serum creatinine =1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5X ULN. 8) Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy test result prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. 9) Females of childbearing potential must agree to use two effective contraceptive methods during the study and for 6 months following the last dose of study drug or agree to completely abstain from heterosexual intercourse. 10) Males, even if surgically sterilized, (i.e., status post vasectomy) must agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug or agree to completely abstain from heterosexual intercourse. 11) Patients must provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1) Previous treatment with BV 2) Peripheral neuropathy > grade 1. 3) Known history of any of the following cardiovascular conditions: a. Myocardial infarction within 2 years of study entry. b. Congestive heart failure, Class III or IV, by the NYHA criteria. c. Evidence of current uncontrolled cardiac arrhythmias, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. d. Recent evidence (within 6 months of study entry) of a left ventricular ejection fraction <50% 4) History of another primary malignancy for within 3 years of study entry. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.) 5) Known cerebral/meningeal disease. 6) Signs or symptoms of progressive multifocal leukoencephalopathy (PML). 7) Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of BV. 8) Current therapy with other systemic anti-neoplastic or investigational agents. 9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of BV. 10) Women who are pregnant or lactating and breastfeeding. 11) Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation of brentuximab vedotin. 12) Known human immunodeficiency virus (HIV) positive. 13) Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection. 14) Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
研究者
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