CTRI/2012/03/002502招募中3 期
A Prospective, Comparative, Randomized, Multicenteric, Phase III study of Rituximab in Patients with NH
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •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
研究者
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