NCT00311129已完成2 期
A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
Genzyme, a Sanofi Company0 个研究点目标入组 41 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma.
详细描述
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
- •Patients with measurable lesions (> 1.5 cm).
- •Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
- •ECOG performance status: 0 - 1
- •Patients with adequately maintained organ functions.
排除标准
- •Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever </=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
- •Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
- •Patients who received G-CSF or transfusion within 1 week before the registration.
- •Patients with the history of allergies to purine nucleoside analogue.
- •Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
- •Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy).
- •Patients who had progressive disease within 6 months of receiving therapy including rituximab.
- •Women who are pregnant, of childbearing potential, or lactating.
- •Patients who do not agree to practice contraception.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Fludarabine Phosphate (Fludara) (Drug)
Arm 2
Active Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
Overall response rate
时间窗: The best response until the end of 6th treatment cycle
次要结局
- CR rate(CR or CRu until the end of 6th treatment cycles)
- Progression free survival(Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient)
- Overall survival(Death, observed until 12 weeks after the completion of the treatment in the last patient)
研究者
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