NCT00061425已完成1 期
Phase I/II Radioimmunotherapy of Non-Hodgkin's Lymphoma With Radiolabeled Humanized Immuno-LL2: Treatment With 90Y-hLL2 IgG
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
研究概览
简要总结
The purpose of this trial is to determine the safety of a 90Y-radiolabeled, humanized (CDR-grafted) form of the LL2 monoclonal antibody in patients with Non-Hodgkin's lymphoma (NHL) at different dose levels.
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
- •Histological or cytological diagnosis of B-cell lymphoma, and has failed at least one regimen of standard chemotherapy. (All histological grades of NHL will be eligible for this trial.)
- •Measureable via CT, with at least one lesion > or = 1.5cm in one or both dimensions. (Splenic tumors in absence of other tumors will not qualify.)
- •Radiological studies (ie - CT) must be performed within 4 weeks prior to study start.
- •Acceptable tumor burden that will allow adequate follow-up and evaluation.
- •Less that 25% bone marrow involvement, determined by bone marrow biopsy.
- •Must observe the following washout periods:
- •At least 4 weeks beyond any major surgery. At least 4 weeks beyond any radiation therapy to the index lesion, and has recovered from radiation-induced toxicity.
- •At least 4 weeks beyond chemotherapy and/or immunotherapy. At least 2 weeks beyond corticosteriod(s) use and blood counts are with laboratory criteria.
- •Must have Karnofsky score >70% (or equivalent, ECOG 0-2) with expected survival of at least 6 months.
- •Serum creatinine < or = 1.5mg/dl or creatinine clearance > or = 50ml/min.
- •Serum bilirubin < or = 2mg/dl.
- •Hemoglobin > or = 10 g/dl; WBC > or = 3000/mm3; granulocyte count > or = 150/mm3; platelet count > or = 100,000/mm3 with out transfusions or cytokines for at least 30 days prior to study.
- •Immunomedics ELISA assay of HahLL2 < 100ng/ml for those with prior history of monoclonal antibody infusions.
- •Cognizant informed consent.
排除标准
- 未提供
研究者
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