NCT00414089撤回2 期
Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Response
研究概览
简要总结
The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch & wait" policy.
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 indolent lymphoma including:
- •follicular grade 1 or 2
- •small lymphocytic
- •marginal zone (nodal)
- •marginal zone (splenic)
- •mucosa associated lymphoid tissue (MALT)
- •no evidence of transformation
- •Stage III or IV disease
- •No prior therapy
- •involvement by less than 25% of bone marrow on assessment of trephine biopsy
- •absolute lymphocyte count ≤ x 109/L
- •platelets ≥ 150 x 109/L
- •hemoglobin ≥ 100g/L
- •absolute neutrophil count ≥ 1.5 x 109/L
- •at least one bidimensionally measurable lesion at least 2cm by CT scanning
排除标准
- •any other anticancer treatment for NHL
- •prior radiation therapy
- •prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
- •no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
- •presence of central nervous system lymphoma
- •patients known to be HIV positive
- •patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
- •patients with abnormal liver function: total bilirubin > 1.5X ULN or ALT > 2.5X ULN
- •patients with abnormal renal function: serum creatinine > 2.5X ULN
- •known hypersensitivity to murine antibodies or proteins
- •immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)
结局指标
主要结局
Response
次要结局
- Progression free survival
研究者
研究点 (2)
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