An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Number of Participants With Objective Response
研究概览
简要总结
The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 DLBCL
- •and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
- •and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
排除标准
- 未提供
研究组 & 干预措施
Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
干预措施: Ofatumumab (Drug)
结局指标
主要结局
Number of Participants With Objective Response
时间窗: 6-month period from start of treatment (up to Week 24)
Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
Number of Participants Classified as Responders and Non-responders for Objective Response
时间窗: 6-month period from start of treatment (up to Week 24)
According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.
次要结局
- Progression-free Survival (PFS)(From date of start of treatment to 2 years or withdrawal)
- Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions(Visit 2 (Week 0) and Visit 9 (Week 7))
- Half-life (T1/2) for Ofatumumab at the Eighth Infusion(Visit 9 (Week 7; up to 11 months after last dose))
- Clearance (CL) of Ofatumumab at the Eighth Infusion(Visit 9 (Week 7; up to 11 months after last dose))
- Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion(Visit 9 (Week 7; up to 11 months after the last dose))
- Duration of Response(From date of start of treatment to 2 years or withdrawal)
- Overall Survival (OS)(From date of start of treatment to 5 years or withdrawal)
- Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18(Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24))
- Percent Change From Screening in Complement (CH50) Levels(Screening and post-baseline visits (last visit was to occur 24 months post first dose))
- AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion(Visit 9 (Week 7; up to 11 months after last dose))
- Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy(From date of start of treatment to 5 years or withdrawal)
- Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits(Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24), Visit 19 (Month 30), Visit 20 (Month 36))
- Number of Participants Who Experienced at Least One Adverse Event (AE)(Time frame is from date of start of treatment to 2 years or withdrawal)