NCT01205737已完成1 期
A Phase Ib, Double Blind RCT to Evaluate and Compare the PK, PD and Safety of MabThera® With TL011, in Combination With CHOP, in Subjects With CD20+ DLBCL
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 41
- 主要终点
- AUC during a dosing interval for Rituximab
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 MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.
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
- 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.
- •2.CD20+ lymphoma cells at screening
- •18-80 (inclusive) years of age at screening
- •Ann Arbor Stages I-IV at screening
- •Any IPI score at screening
- •ECOG good performance status (0-2) at screening
- •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
- •Any lymphoma other than CD20+ DLBCL
- •History of indolent lymphoma
- •DLBCL with central nervous system or meningeal involvement
- •Primary gastrointestinal (MALT) lymphoma
- •Bulky disease>10 cm diagnosed by imaging at screening
- •Bone marrow involvement > 25% according to bone marrow biopsy at screening
- •Subjects previously treated with chemotherapy, radiotherapy, immunotherapy or experimental therapies for lymphoma or other malignancy
- •Hypersensitivity to active ingredients, excipients (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections) and murine proteins
- •Active uncontrolled infection (viral, bacterial or fungal infection) requiring systemic therapy at screening and/or at baseline visit.
- •A documented history of recurrent or chronic clinically significant infection (viral, bacterial or fungal infection)
- •Subjects with a history of tuberculosis or active tuberculosis at screening.
- •Immunodeficiency syndrome or Human immunodeficiency virus (HIV) seropositivity
- •Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- •History of other cancer within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of uterine cervix
- •Any major surgical procedure within 12 weeks prior to screening and between screening and baseline
- •Immunization with live viral vaccines less than 4 weeks prior to first study drug infusion, and/or planned live viral vaccination during study period.
- •Known allergic reactions against foreign proteins
- •Subjects for whom 8 cycles of CHOP might be problematic, and have the following findings/conditions, should not be enrolled:
- •Cardiac contra-indication to doxorubicin: Left ventricular ejection fraction (LVEF) < 50% according to multi-acquisition gated (MUGA) scan or 2D Echocardiogram at screening
- •Neurologic contra-indication to vincristine: (e.g., peripheral neuropathy)
- •Abnormal hepatic function at screening and/or baseline
- •AST/ALT ≥ 3 x upper normal value (ULN) or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
- •Bilirubin ≥ 2 x ULN or ≥ 5 x ULN in the presence of DLBCL involvement of the liver
- •Abnormal renal function at screening and/or baseline
- •Serum creatinine ≥ 2 x ULN
- •Abnormal bone marrow function at screening and/or baseline
- •Platelets < 100x109/L
- •Neutrophils < 1.5x109/L
- •Hb < 9g/dL
- •Any other serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the Investigator Brochure of TL011)
- •Subjects who, according to the investigator, are likely to be non-compliant or uncooperative during the study.
- •Pregnant or lactating 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 planned first cycle of chemotherapy.
结局指标
主要结局
AUC during a dosing interval for Rituximab
时间窗: 21 weeks
次要结局
- PK and PD parameters(Throughout study)
研究者
研究点 (41)
Loading locations...
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