Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Long-Term Follow-Up Study Evaluating the Efficacy and Delayed Toxicities of Radioiodinated Tositumomab (Anti-CD20 Antibody) Followed by Autologous Transplantation for Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.
PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma.
研究概览
详细说明
OBJECTIVES:
- Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I^131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296, 521, 792, or 915.
- Determine the long-term toxic effects of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a long-term, follow-up study.
Patients undergo testing for human anti-mouse antibody at 1, 3 and 12 months. Patients undergo physical examinations, blood tests, and immune system assessments every 3 months for 1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at 1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if clinically indicated) annually for up to 10 years.
Quality of life is assessed annually.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Washington
-
Seattle、Washington、美国、98109-1024
- Fred Hutchinson Cancer Research Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:
- FHCRC-296
- FHCRC-521
- FHCRC-792
- FHCRC-915
描述
DISEASE CHARACTERISTICS:
Diagnosis of B-cell non-Hodgkin's lymphoma
- Relapsed or refractory disease
Previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:
- FHCRC-296
- FHCRC-521
- FHCRC-792
- FHCRC-915
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually
大体时间：Annual throughout survival
|
Annual throughout survival
|
|
Toxicity of patients on phase I and II trials by NCI CTC scale annually
大体时间：Annual throughout survival
|
Annual throughout survival
|
合作者和调查者
调查人员
- 首席研究员：Oliver W. Press, MD, PhD、Fred Hutchinson Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 1734.00
- FHCRC-1734.00
- CDR0000398806 (注册表标识符：PDQ)
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