A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by continuous IV infusion for 7 consecutive days using a portable infusion pump. Hospitalization is not required. Stable or responding patients will receive additional gallium nitrate infusions every 3 weeks until the time of disease progression, for a maximum total of 8 infusions, or 2 cycles after complete remission has been documented.
详细描述
This study seeks to define the role of gallium nitrate in a specific population of patients who are expected to have received prior therapy. Preliminary clinical studies have suggested substantial evidence of antitumor activity in patients with relapsed or refractory non-Hodgkin's Lymphoma treated with gallium nitrate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Low- or intermediate-grade NHL using the International Working Formulation, subtypes IWF A-G:
- •Using the Updated REAL/WHO Classification, the following pathologic subtypes are eligible:
- •Small lymphocytic lymphoma
- •Lymphoplasmacytic lymphoma/immunocytoma
- •Follicular lymphoma
- •Diffuse large B-cell lymphoma
- •Peripheral T-cell lymphoma, not otherwise characterized
- •Progression of disease following treatment with standard chemotherapy
- •Bi-dimensionally measurable disease
- •Performance Status: ECOG < = 2
- •Patients with mantle cell lymphoma or mycosis fungoides are not eligible
- •Patients with known history of CNS metastasis are not eligible
排除标准
- 未提供