A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 151
- 试验地点
- 66
- 主要终点
- Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
研究概览
简要总结
This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.
- •Received at least four cycles of first-line therapy with R-CHOP, or equivalent.
- •Best clinical response to first-line therapy of stable disease, partial response, or complete response.
- •At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan.
排除标准
- •Leptomeningeal or central nervous system lymphoma.
- •Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.
- •Received a hematopoietic stem cell transplant.
研究组 & 干预措施
1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
干预措施: carboplatin (Drug)
1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
干预措施: SGN-40 (Drug)
1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
干预措施: rituximab (Drug)
1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
干预措施: etoposide (Drug)
1
SGN-40, rituximab, etoposide, carboplatin, ifosfamide
干预措施: ifosfamide (Drug)
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
干预措施: placebo (Drug)
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
干预措施: rituximab (Drug)
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
干预措施: etoposide (Drug)
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
干预措施: carboplatin (Drug)
2
placebo, rituximab, etoposide, carboplatin, ifosfamide
干预措施: ifosfamide (Drug)
结局指标
主要结局
Complete response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
时间窗: 9 weeks
次要结局
- Adverse events, laboratory values, and anti-drug antibody immune responses.(9 weeks)
- Partial response, failure free survival, overall survival, and response for one and two years following treatment.(Every 3 months for 2 years)