Comparative,Randomized,Double Blind Study to Evaluate Biologic Effect and Safety of PBO-326 (Rituximab), Associated to CHOP-14 Compared With Mabthera (Rituximab) Associated to CHOP-14 in B Cells CD20+ Diffuse Non-Hodgkin Lymphoma Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Basal and final serum CD 20 levels comparison.
研究概览
简要总结
This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of PBO-326 (Rituximab) and Mabthera (Rituximab) in combination with CHOP in previously untreated patients with diffuse B cells Non Hodgkin lymphoma.
详细描述
At present R-CHOP (Rituximab plus Cyclofosfamide, Doxorrubicine, Vincristine and Prednisone) has became standard of care of patients with B cells Non Hodgkin Lymphoma CD20+.
Study will perform pharmacodynamic (PD) and pharmacokinetic (PK) measurment of a novel Rituximab in comparison with Mabthera and evaluates safety both metabolic as well immunologic.
Study protocolo is designed to provide data on impact of treatment interchange of both study drugs (PBO-326 and Mabthera).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification.
- •CD20+ lymphoma cells at screening.
- •> 18 years of age at screening.
- •Ann Arbor Stages I-IV at screening.
- •Any IPI score at screening.
- •Easten Cooperative Oncology Group (ECOG) performance status (0-2) or Karnofsky scale > 60 at screening.
- •Left ventricular ejection fraction > 50%.
- •Willing and able to provide written informed consent prior to performing study procedures.
- •Women of childbearing potential must use effective contraceptive methods starting from screening and until 12 months following the last infusion.
排除标准
- •Hodgkin lymphoma.
- •Any lymphoma other than CD20+ Diffuse Large B Cell Lymphoma (DLBCL).
- •Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity .
- •Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
- •Function Liver tests >2 x upper normal values.
- •Positive Hepatitis B surface antigen or antibodies to Hepatitis C.
- •Any other serious active disease or co-morbid medical condition.
- •Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
- •Pregnant or breast-feeding women or women that intend to get pregnant during study or within 12 months following the last infusion.
- •Treatment with any investigational drug within 90 days before day 1 of study treatment.
结局指标
主要结局
Basal and final serum CD 20 levels comparison.
时间窗: Every 14 days for the duration of treatment
Primary outcome is the depletion of CD20+ B cells. This will be measured every 14 days and comparison will be made basal levels versus visit 2, visit 3, visit 4, visit 5, visit 6, visit 7 and visit 8.
次要结局
- Comparison of safety of PBO-326 versus Mabthera(Every 14 days measurements)