CTRI/2012/03/002502招募中3 期
A Prospective, Comparative, Randomized, Multicenteric, Phase III study of Rituximab in Patients with NHL
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Objective Response rate; Safety endpoints,AE evaluation, anti-rituximab antibody development
研究概览
简要总结
This is a Phase III, Randomized, Comparative, Multicenteric study. This will be a study where patients with previously untreated diffuse large Bcell, CD20-positive NHL will receive Rituximab of Intas Biopharmaceuticals Ltd and CHOP against MabThera of Roche and CHOP. Total of 100 patients will be randomized in ratio of 3:1. The study duration is for 2 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria Adult men and women greater or equal to 18 years Patients with histologically confirmed diffuse large B-cell CD20 positive NHL or follicular B-cell Lymphoma Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) Normal hematopoietic hepatic and renal function as follows Absolute neutrophil count (ANC) greater than or equal to 1000 per mm3 (unless due to non-Hodgkins lymphoma (NHL) bone marrow involvement) AST ALT less than or equal to 3 multiplied ULN Bilirubin less than or equal 1.5 multiplied ULN Serum creatinine less than 1.5 multiplied ULN Woman of child bearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use medically acceptable forms of contraception during the study and for three months after the last treatment intake Patients able to understand and voluntarily provide written informed consent before screening following an explanation of the nature and purpose of this study No other serious disease or medical condition that would interfere with compliance.
排除标准
- •Patients who had prior anti CD20 therapy Hypersensitivity to Rituximab Any other malignancy in the last 2 years other than non-Hodgkins Lymphoma Any history or presence of clinically significant cardiovascular Respiratory hepatic renal hematologic gastrointestinal endocrine immunologic dermatologic neurologic or psychiatric disease or any other condition which in the opinion of the Investigator could jeopardize the safety of the subject or the validity of the study results According to investigators opinion patients general status do not permit the administration of CHOP Pregnant or breast-feeding patients (for female patients of child bearing potential) Have received any Investigational product in last 30 days or going to receive any Investigational product during the study period Suspected or confirmed poor compliance according to investigators judgment in completing the trial and follow up.
结局指标
主要结局
Objective Response rate; Safety endpoints,AE evaluation, anti-rituximab antibody development
时间窗: 21 days cycle
次要结局
- Pharmacokinetic assessment(in cycle 1)
研究者
研究点 (28)
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