NCT00086034已完成2 期
Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent 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
- 35
- 试验地点
- 7
- 主要终点
- Clinical response rate
研究概览
简要总结
The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.
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
- •≥ 18 years old
- •Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
- •Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
- •ECOG performance status score either 0 or 1
- •Willing and able to provide written informed consent
排除标准
- •Laboratory values of:
- •Platelet count < 50,000/µL
- •AST or ALT > 2 x the upper limit of normal (ULN)
- •Total bilirubin > 2 x ULN
- •Creatinine > 2.0 mg/dL
- •Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
- •Uncontrolled hypertension
- •Known history of porphyria, G6PD deficiency, HIV
结局指标
主要结局
Clinical response rate
次要结局
- Progression-free survival
- Duration of clinical response
- Safety and tolerability
研究者
研究点 (7)
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