NCT00533728已完成1 期
A Phase I Study to Determine the Safety and Effect of Soluble Beta-Glucan (SBG) in Combination With Rituximab and COP/CHOP in Patients With Non'Hodgkin's Lymphoma
Biotec Pharmacon ASA2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to assess the safety of soluble beta-glucan (SBG) in combination with antibody and chemotherapy treatment in patients with non-Hodgkin-s lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CD20 positive B-cell non-Hodgkin's lymphoma
- •Treatment with rituximab and CHOP or COP
- •Performance status 0 or 1 according to the WHO scale (Appendix)
- •Expected lifetime of more than 12 weeks
- •Age ≥ 18 years
- •The patient must be able and willing to comply with the study procedures, and signed and dated informed consent must be obtained
排除标准
- •Women who are pregnant or breast-feeding. For fertile women, a negative pregnancy test must be provided during the screening test. Women of childbearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
- •Lymphoma involvement of central nervous system
- •Reduced bone marrow function defined by leukocyte counts < 3.0 x 109/l, neutrophil counts < 1.5 x 109/l, thrombocyte counts < 100 x 109/l or hemoglobin < 10 g/dl
- •Reduced liver function defined by bilirubin > 1.5 x upper limit of normal (ULN) or ASAT/ALAT ≥ 3 x ULN
- •Reduced renal function defined by serum creatinine ≥ 2 x ULN
研究者
研究点 (2)
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