An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
研究概览
简要总结
To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)
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
- 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
- •Patient with Follicular Lymphoma (FL)
- •Confirmed diagnosis of Follicular lymphoma
- •18 years or above
- •Verbal and written information about the study
排除标准
- •No previous treatment for Follicular Lymphoma
- •Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
- •Several diseases such as malignancies etc.
- •Screening laboratory values
- •Current participation in any other interventional clinical study
- •Breast feeding women or pregnant women
- •Women of childbearing potential not willing to use adequate contraception
研究组 & 干预措施
Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
干预措施: Ofatumumab (Drug)
Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
干预措施: Cyclophosphamide (Drug)
Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
干预措施: Doxorubicin (Drug)
Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
干预措施: Vincristine (Drug)
Active Comparator 1
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
干预措施: Prednisolone, Prednisone or equivalent (Drug)
Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
干预措施: Ofatumumab (Drug)
Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
干预措施: Cyclophosphamide (Drug)
Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
干预措施: Doxorubicin (Drug)
Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
干预措施: Vincristine (Drug)
Active Comparator 2
Each patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
干预措施: Prednisolone, Prednisone or equivalent (Drug)
结局指标
主要结局
Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)
时间窗: Maximum of 23 months after the start of treatment
Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (\>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; \<50% decrease in LN size from baseline) and progressive disease (PD; \>=50% increase in LN size and evidence of new lesions).
次要结局
- Progression-Free Survival (PFS)(Followed up to 5 years)
- Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)(Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months))
- Time to New Anti-follicular Lymphoma (FL) Therapy(Followed up to 5 years)
- Duration of Response(Followed up to 5 years)
- Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)(Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months))
- Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)(Up to 22 months after study start)
- Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33(Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose))
- Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22(Visit 1 (Screening, Week -2) and Visit 22 (Week 15))
- Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy(Maximum of 6 years follow-up)
- Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)(Week 15 (Visit 22))
- AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)(Week 15 (Visit 22))
- Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)(Week 15 (Visit 22))
- CL After the Sixth Infusion (Week 15, Visit 22)(Week 15 (Visit 22))
- Vss at the Sixth Infusion (Week 15, Visit 22)(Week 15 (Visit 22))
- Number of Participants With Complete Remission (CR) at Visit 26(Maximum of 23 months after the start of treatment)