A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Number of Participants With Objective Response (OR)
研究概览
简要总结
A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy
详细描述
Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.
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
- Single (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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Objective Response (OR)
时间窗: Start of treatment (Day 1 of Week 0) until 3 months after start of last infusion (up to Week 32)
OR was assessed by an Independent endpoints Review Committee (IRC) according to the standardized response criteria for Non-Hodgkin's lymphoma. Participants with Complete Response (CR; complete disappearance of all detectable disease), Complete Response unconfirmed (CRu; any residual lymph node/nodal mass \>1.5 centimeters \[cm\] in its longest transverse diameter that regressed \>75% compared to baseline), or Partial Response (PR; \>=50% decrease in the sum of the product of diameters of indicator lesions) were defined as responders for OR.
Number of Participants Classified as Responders and Non-responders for Objective Response (OR)
时间窗: 6-month period from the start of treatment. There was a median time of response at Month 5.5 (participants were followed for up to 24 months).
Based on OR over a 6-month period from start of treatment, participants were classified as responders/non-responders as follows: participants with CR, CRu, or PR were classified as responders, whereas participants with Stable Disease (SD; achieving less than PR but not consistent with PD), Progressive Disease (PD; 50% increase from nadir in the products of the greatest perpendicular diameters of any previously identified node or appearance of any new node \>1 cm), or Not Evaluable (NE) participants were classified as non-responders.
次要结局
- Duration of Response(From start of treatment (Week 0) until Month 24)
- Overall Survival(First dose (Week 0) until 5 years)
- Percent Change From Screening (Visit 1) in Tumor Size as Assessed by Radiologist 1 (R1) and Radiologist 2 (R2) at Months 3, 6, 9, 12, 18, and 24(Visits 1 (Week -2), 11 (Month 3), 12 (Month 6), 13 (Month 9), 14 (Month 12), 16 (Month 18), and 18 (Month 24))
- Percent Change From Baseline (Visit 2) in CD19+ and CD20+ Cells in Peripheral Blood at Visits 11 and 12(Visits 2 (Baseline), 11 (Month 3), and 12 (Month 6))
- Number of Participants With Conversion and no Conversion of BCL2 Positive to BCL2 Negative in Peripheral Blood(Screening (Visit 1) until Month 24 (Visit 18))
- Number of Participants Who Experienced Any Adverse Event From First Treatment (Visit 2) to Visit 18 (Month 24)(From first treatment (Visit 2) until Visit 18 (Month 24))
- Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 12, 13, and 14(Visits 1 (Screening), 12 (Month 6), 13 (Month 9), and 18 (Month 24))
- Progression-Free Survival(From start of treatment (Week 0) until Month 24)
- Time to Next Follicular Lymphoma (FL) Therapy(From start of treatment (Week 0) until Month 24)
- Complement (CH50) Levels at Visit 1 and at the End of Infusion at Visit 2(Visits 1 (Week -2) and 2 (Week 0))
- Number of Participants Classified as Responders for Fragment C Receptor (FcR) Polymorphism (Poly.)(From first treatment (Visit 2) until Visit 12 (Month 6))
- Ctrough and Cmax at the Eighth Infusion (Visit 9, Week 7)(Visit 9 (Week 7; up to 10 months after dose))
- AUC(0-inf) and AUC(0-168) After the Eighth Infusion (Visit 9, Week 7)(Visit 9 (Week 7; up to 10 months after dose))
- t1/2 After the Eighth Infusion (Visit 9, Week 7)(Visit 9 (Week 7; up to 10 months after dose))
- CL After the Eighth Infusion (Visit 9, Week 7)(Visit 9 (Week 7; up to 10 months after dose))
- Vss After the Eighth Infusion (Visit 9, Week 7)(Visit 9 (Week 7; to up 10 months after dose))