EUCTR2009-016947-20-CZ进行中（未招募）1 期
A randomized, double-blind, placebo-controlled Phase 3 study of SGN-35 (brentuximab vedotin) and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT)
Seattle Genetics, Inc.0 个研究点目标入组 322 人开始时间: 2010年3月26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
- 322
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 with HL who have received ASCT in the previous 30–45 days.
- •2. Patients at high risk of residual HL post ASCT as indicated by at least one of the following criteria. Patients prematurely discontinuing planned frontline therapy for reasons other than disease progression are not considered high risk.
- •-History of refractory HL (defined as patients progressing on or failing to achieve a complete remission following frontline standard chemotherapy or a combined modality treatment program)
- •-Relapsed or progressive HL that occurs <12 months from the end of frontline standard chemotherapy or a combined modality treatment program
- •- Extranodal involvement at the time of pre-ASCT relapse (including extranodal extension of nodal masses into adjacent vital organs)
- •3. Histologically-confirmed classical HL, which excludes NLPHL.
- •4. Age greater than or equal to 18 years.
- •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 (unsupported), 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 311
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Previous treatment with SGN-35.
- •2. Previously received an allogeneic transplant.
- •3. Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT.
- •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, 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.)
- •5. Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
- •6. Any Grade 3 or higher active infection within 1 week prior to first study dose.
- •7. Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents.
- •8. Women who are pregnant or lactating.
- •9. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
- •10. 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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