NCT00184080已完成2 期
A Multicenter Open-Label Non-Randomized Phase II Study of Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to evaluate the safety of an experimental drug called Elsamitrucin in people with non-Hodgkin's lymphoma and to see if it can shrink their tumors. Elsamitrucin has not been approved by the Food and Drug Administration (FDA). However, the FDA is permitting the use of this drug for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed NHL both B and T-cell that is refractory to or has relapsed after standard therapy or for which there is no known effective treatment.
- •CT or MRI scans confirming measurable tumor size (lymph node must be >1.0 cm in its longest transverse diameter). Measurement by PE is acceptable, in the case of palpable and reproducibly measurable tumors. Patients with CLL/smal lymphocytic lymphoma are eligible without bidimensional measurable disease.
- •ECOG Performance Status 0-2
- •Age greater or equal to 18 years of old
- •AGC greater or equal to 1.0; platelets greater or equal to 75,000;Ggb greater or equal to 9.
- •(Lower values may be accepted for cytopenias due to bone marrow involvement by lymphoma, after discussion with sponsor)
- •Bilirubin less or equal to 2.0; SGOT and SGPT less of equal to 3 times upper limit of normal
- •Creatinine <1.5; BUN <25
- •Expected survival >6 months
排除标准
- •Prior therapy with Elsamitrucin
- •Any therapy for lymphoma, including chemotherapy, antibody therapy, RT, or any investigational therapy within 28 days prior to study drug administration
- •Steroid therapy within the last 4 weeks prior to study drug administration
- •Evidence of clinically significant uncontrolled condition/s and/or is considered by investigator to be unable to tolerate the required therapy or procedures
- •Known AIDS syndrome or HIV-associated complex (severely depressed immune system)
- •Prior or other current malignancy within 5 years, except for adequately treated cone-biopsied in-situ cervical cancer or resected basal cell or squamous cell skin cancer
- •Any current medical or psychiatric disease that would prevent informed consent and expected cooperation of the patient for therapy and follow-up
- •Pregnant or lactating women.
研究者
研究点 (2)
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