NCT01100502已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 329
- 试验地点
- 87
- 主要终点
- Progression-free Survival by Independent Review
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HL who have received ASCT in the previous 30-45 days
- •Patients at high risk of residual HL post ASCT
- •Histologically-confirmed HL
- •ECOG of 0 or 1
- •Adequate organ function
排除标准
- •Previous treatment with brentuximab vedotin
- •Previously received an allogeneic transplant
- •Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
研究组 & 干预措施
Brentuximab vedotin
Experimental
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
干预措施: brentuximab vedotin (Drug)
Placebo
Placebo Comparator
placebo every 3 weeks by IV infusion
干预措施: placebo (Drug)
结局指标
主要结局
Progression-free Survival by Independent Review
时间窗: Up to approximately 4 years
Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
次要结局
- Overall Survival(Up to approximately 10 years)
- Incidence of Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin(Up to 12 months)
- Incidence of Adverse Events or Laboratory Abnormalities(Up to 12 months)
研究者
研究点 (87)
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