EUCTR2012-000735-27-IT进行中（未招募）1 期
A phase II study of SGN-35 (brentuximab vedotin) of patients with relapsed or refractory Primary mediastinal large B-cell lymphoma (PMLBCL).
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点目标入组 20 人开始时间: 2013年3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
- 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
- •Patients must meet all of the following inclusion criteria to be eligible for this study:
- •1)Patients with relapsed or refractory PMLBCL who have previously received at least 1 line of treatment. Patients must have completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of Brentuximab vedotin.
- •2)Histologically-confirmed CD30-positive disease.
- •3)Age greater than or equal to 18 years.
- •4)Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
- •5)An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6)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.
- •7)Females of childbearing potential must have a negative serum or urine 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 postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
- •8)Both females of childbearing potential and males who have partners of childbearing potential must agree to use two effective contraceptive methods during the study and for 30 days following the last dose of study drug.
- •9)Male patients, even if surgically sterilized (i.e., post vasectomy), who:
- •Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of the study drug, or
- •Agree to completely abstain from heterosexual intercourse
- •10)Patients or their legally authorized representative 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) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for study:
- •1)Previous treatment with Brentuximab vedotin.
- •2)Previously received an allogeneic transplant.
- •3)Congestive heart failure, Class III or IV, by the NYHA criteria.
- •4)History of another primary malignancy for at least 3 years. (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 Brentuximab vedotin.
- •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 Brentuximab vedotin.
- •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.
- •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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