A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 5
- 主要终点
- Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.
详细描述
This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of Tafasitamab in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor: blinding on treatment group
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tafasitamab and bendamustine
Tafasitamab and bendamustine
干预措施: Tafasitamab (Drug)
Tafasitamab and bendamustine
Tafasitamab and bendamustine
干预措施: Bendamustine (BEN) (Drug)
Rituximab and bendamustine
Rituximab and bendamustine
干预措施: Rituximab (RTX) (Drug)
Rituximab and bendamustine
Rituximab and bendamustine
干预措施: Bendamustine (BEN) (Drug)
结局指标
主要结局
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Overall Population
时间窗: up to 41.4 months
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
Kaplan-Meier Estimate of Progression-Free Survival by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup
时间窗: up to 46.5 months
Progression-free survival was defined as the time from randomization to tumor progression or death from any cause.
次要结局
- Kaplan-Meier Estimate of Overall Survival in the Overall Population(up to 50.0 months)
- Kaplan-Meier Estimate of Overall Survival in the Natural Killer Cell Count-Low Subgroup(up to 50.6 months)
- Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Overall Population(up to 40.2 months)
- Kaplan-Meier Estimate of Duration of Response by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup(up to 44.7 months)
- Disease Control Rate (DCR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population(up to 77 months)
- DCR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup(up to 77 months)
- Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Overall Population(up to 25.8 months)
- Kaplan-Meier Estimate of Time to Progression by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup(up to 40.6 months)
- Kaplan-Meier Estimate of Time to Next Treatment in the Overall Population(up to 59.4 months)
- Kaplan-Meier Estimate of Time to Next Treatment in the Natural Killer Cell Count-Low Subgroup(up to 70.1 months)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 77 months)
- Number of Participants With Any Grade 3 or Higher TEAE(up to 77 months)
- Best Objective Response Rate (ORR) by Independent Radiology/Clinical Review Committee Assessment in the Overall Population(up to 77 months)
- Best ORR by Independent Radiology/Clinical Review Committee Assessment in the Natural Killer Cell Count-Low Subgroup(up to 77 months)
- Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Overall Population(Baseline; End of Treatment (EOT) (up to 77 months))
- Change From Baseline (CFB) in the EORTC QLQ-C30 Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup(Baseline; End of Treatment (EOT) (up to 77 months))
- Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Overall Population(Baseline; End of Treatment (EOT) (up to 77 months))
- Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Overall Population(Baseline; End of Treatment (EOT) (up to 77 months))
- Change From Baseline (CFB) in EQ-5D-5L VAS Score at End of Treatment in the Natural Killer Cell Count-Low Subgroup(Baseline; End of Treatment (EOT) (up to 77 months))
- Change From Baseline (CFB) in EQ-5D-5L Dimension Scores at End of Treatment in the Natural Killer Cell Count-Low Subgroup(Baseline; End of Treatment (EOT) (up to 77 months))
- Tafasitamab Serum Concentrations(pre-dose: Cycle 1 Days 1, 2, 3, 4, 15; Cycle 2 Days 1, 15; Cycle 3 Days 1, 15, Cycles 4, 5, 6, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35 Day 1. 1 hour post-dose: Cycle 1 Days 1, 4, 15; Cycle 2 Days 1, 15; Cycle 3 Days 1, 15)