EUCTR2008-006034-10-FR进行中（未招募）1 期
A pivotal study of SGN-35 in treatment of patients with relapsed or refractory Hodgkin Lymphoma (HL)
Seattle Genetics, Inc.0 个研究点目标入组 102 人开始时间: 2009年3月17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
- 102
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
- •To be eligible for this study, patients must meet all of the following inclusion criteria :
- •1. Patients with relapsed or refractory HL who have previously received ASCT. Patients must have received prior ASCT at least 12 weeks (3 months) before the first dose of SGN-35 and completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35.
- •2. Histologically-confirmed CD30-positive disease; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained.
- •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) =1000/µL, platelets =50,000/µL, 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 SGN-35. 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 an effective contraceptive method during the study and for 30 days following the last dose of study drug.
- •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
- •If a patient is positive for any of the following exclusion criteria, the patient will not be eligible for this study:
- •1. Previous treatment with SGN-35.
- •2. Previously received an allogeneic transplant.
- •3. Congestive heart failure, Class III or IV, by the NYHA criteria.
- •4. 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, 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. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35.
- •7. Current therapy with other systemic anti-neoplastic or investigational agents.
- •8. Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of SGN-35.
- •9. Women who are pregnant or lactating.
- •10. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
- •11. 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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