EUCTR2010-020363-21-FR进行中（未招募）1 期
An open-label, phase 2/3, treatment-option protocol ofbrentuximab vedotin in patients with progression of Hodgkinlymphoma
Seattle Genetics, Inc.0 个研究点目标入组 80 人开始时间: 2010年7月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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. Patients who met all inclusion/exclusion criteria for and participated in the SGN35-005 clinical study.
- •2. Patients who were treated with placebo in the SGN35-005 clinical study after autologous hematopoietic
- •stem cell transplantation (ASCT) and experienced progression of HL based on the Revised Response
- •Criteria for Malignant Lymphoma (Cheson 2007) as defined by protocol in study SGN35-005.
- •3. Age greater than or equal to 18 years.
- •4. An Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •5. Patients must have completed any previous treatment with radiation, chemotherapy, biologics and/or
- •investigational agents at least 4 weeks prior to the first dose of SGN-35.
- •6. 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 for more than 1 year or who have had a bilateral tubal ligation or
- •hysterectomy.
- •7. Both females of childbearing potential and males who have partners of childbearing potential must
- •agree to use an effective contraceptive method during the study and for 30 days following the last dose
- •of study drug.
- •8. The following baseline laboratory values are required: absolute neutrophil count (ANC) =1000/µL,
- •platelets =50,000/µL, bilirubin =1.5 x upper limit of normal (ULN) or =3 x ULN for patients with
- •Gilbert’s disease, serum creatinine =1.5 x ULN, alanine aminotransferase (ALT) and aspartate
- •aminotransferase (AST) =2.5 x ULN.
- •9. 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any Grade 3 viral, bacterial, or fungal infection requiring treatment with therapy within 1 week prior to
- •the first study dose.
- •2. Patients with = Grade 2 peripheral neuropathy.
- •3. History of another primary malignancy that has not been in remission for at least 3 years. (The
- •following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ
- •[Stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a
- •squamous intraepithelial lesion on PAP smear.)
- •4. Known cerebral/meningeal disease.
- •5. Current therapy with other systemic anti-neoplastic or investigational agents.
- •6. Women who are pregnant or lactating.
- •7. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
- •8. Patients with dementia or an altered mental state that would preclude the understanding and rendering
- •of informed consent.
- •9. Patients who are eligible for participation in other clinical studies of brentuximab vedotin at their
- •institution.
研究者
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