NCT00064246已完成1 期
A Phase I/II Study: Zevalin Radioimmunotherapy for Patients With Post Transplant Lymphoproliferative Disease Following Solid Organ Transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
Phase I/II trial to study the effectiveness of combining yttrium Y 90 ibritumomab tiuxetan with rituximab in treating patients who have localized or recurrent lymphoproliferative disorder after an organ transplant. Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells
详细描述
OBJECTIVES:
I. Determine the safety and tolerability of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) in patients with post-transplant lymphoproliferative disorder.
II. Determine the safety and toxicity profile of IDEC-Y2B8 and rituximab in these patients.
III. Correlate the Epstein-Barr virus viral load with response and relapse in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 post-transplant lymphoproliferative disorder (PTLD) of 1 of the following stages:
- •Stage III or IV
- •Localized (not amenable to localized radiotherapy or excision)
- •Recurrent
- •The following histologies* are eligible:
- •Polyclonal PTLD
- •Monoclonal PTLD
- •Diffuse large B-cell non-Hodgkin's lymphoma (NHL)
- •Lymphoplasmacytic NHL
- •Burkitt/Burkitt-like NHL
- •Must not have completely responded during OR progressed after prior rituximab with or without chemotherapy
- •No history of rapid disease progression while receiving prior chemotherapy
- •Measurable disease
- •Must have less than 25% bone marrow involvement with lymphoma
- •Prior solid organ transplantation required
- •Evaluation of malignant cells for Epstein-Barr virus (EBV) required
- •EBV positive or negative allowed
- •No pleural effusion
- •No CNS lymphoma, including leptomeningeal disease
- •No pulmonary involvement by NHL in patients with prior lung transplantation
- •No HIV or AIDS-related lymphoma
- •No hypocellular bone marrow (i.e., less than 15% cellularity)
- •No marked reduction in bone marrow precursors of one or more cell lines (i.e., granulocytic, megakaryocytic, or erythroid)
- •Performance status - Karnofsky 50-100%
- •At least 3 months
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Bilirubin no greater than 2.5 mg/dL
- •Creatinine no greater than 2.5 mg/dL
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study participation
- •HIV negative
- •No serious nonmalignant disease or infection that would compromise study objectives
- •No presence of antimurine antibody reactivity
- •No other concurrent active malignancy requiring therapy
- •More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- •More than 6 weeks since prior rituximab
- •No prior allogeneic bone marrow or hematopoietic stem cell transplantation
- •No prior radioimmunotherapy for NHL
- •More than 4 weeks since prior chemotherapy
- •See Biologic therapy
- •No prior radiotherapy to more than 25% of active bone marrow (involved field or regional)
- •More than 4 weeks since prior major surgery except diagnostic surgery
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: Up to 4 years
Estimated using binomial proportions and their 95% confidence intervals.
次要结局
- Time to response(Up to 4 years)
- Time to progression(From the date of first study treatment to the first date when progressive disease is documented, assessed up to 4 years)
- Incidence of toxicity related dose reductions graded according to the NCI CTCAE version 3.0(Up to 4 years)
研究者
研究点 (2)
Loading locations...
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