NCT00866047已完成2 期
A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 58
- 试验地点
- 22
- 主要终点
- Objective Response Rate by Independent Review Group
研究概览
简要总结
This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.
- •Documented anaplastic lymphoma kinase (ALK) status.
- •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.
- •Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
- •Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
- •At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.
排除标准
- •Previous treatment with brentuximab vedotin.
- •Previously received an allogeneic transplant.
- •Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
- •Known cerebral/meningeal disease.
研究组 & 干预措施
Brentuximab vedotin
Experimental
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
干预措施: brentuximab vedotin (Drug)
结局指标
主要结局
Objective Response Rate by Independent Review Group
时间窗: up to 12 months
Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.
次要结局
- Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis(up to approximately 3 years)
- Complete Remission Rate by Independent Review Group(up to 12 months)
- Duration of Objective Response by Kaplan-Meier Analysis(up to approximately 3 years)
- Progression-free Survival by Kaplan-Meier Analysis(up to approximately 3 years)
- Overall Survival(up to approximately 7 years)
- Adverse Events by Severity, Seriousness, and Relationship to Treatment(up to 12 months)
- Hematology Laboratory Abnormalities >/= Grade 3(up to 12 months)
- Chemistry Laboratory Abnormalities >/= Grade 3(up to 12 months)
- Area Under the Curve(3 weeks)
- Maximum Serum Concentration(3 weeks)
- Time of Maximum Serum Concentration(3 weeks)
研究者
研究点 (22)
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