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Iodine I 131 Tositumomab Followed by Autologous Stem Cell Transplantation in Treating Older Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

2015年2月3日 更新者:Fred Hutchinson Cancer Center

A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Combining a radiolabeled monoclonal antibody with autologous stem cell transplantation may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combining iodine I 131 tositumomab with autologous stem cell transplantation in treating older patients who have relapsed or refractory non-Hodgkin's lymphoma.

研究概览

详细说明

OBJECTIVES:

Primary

  • Determine the progression-free survival of older patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous stem cell transplantation.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE:

  • Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until day -4.
  • Autologous stem cell transplantation: Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 0 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.

研究类型

介入性

注册 (实际的)

25

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Washington
      • Seattle、Washington、美国、98109-1024
        • Fred Hutchinson Cancer Research Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma
  • CD20+ disease
  • Failed at least 1 prior standard systemic therapy
  • Persistent lymphoma by physical examination, radiographic studies, bone marrow evaluations, flow cytometry, or polymerase chain reaction
  • Tumor burden less than 500 cc by computed tomography or MRI

    • No splenomegaly
  • Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved

    • No circulating lymphoma cells by morphology or flow cytometry at or near the time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be used
    • 10% or less marrow involvement by flow cytometry or morphology if purged bone marrow is to be used
  • No CNS lymphoma
  • No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated lymphocytic lymphoma

PATIENT CHARACTERISTICS:

Age

  • 60 to 80

Performance status

  • SWOG 0-1

Life expectancy

  • More than 60 days

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Bilirubin less than 1.5 mg/dL

Renal

  • Creatinine less than 2.0 mg/dL

Cardiovascular

  • No active coronary artery disease

Pulmonary

  • FEV_1 at least 70% of expected
  • Vital capacity at least 70% of expected

Other

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • Able to perform self-care during radiation isolation
  • No major organ dysfunction
  • No major infection
  • No circulating anti-mouse antibody
  • No other serious medical condition considered to represent contraindications to bone marrow transplantation
  • No competing causes of death that would predict life span to be less than 10 additional years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior bone marrow or stem cell transplantation

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or more than 25% of red marrow)

Surgery

  • Not specified

Other

  • More than 30 days since prior systemic antilymphoma therapy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Disease-free survival measured continuously
大体时间:from date of transplant through date of death
from date of transplant through date of death

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Ajay K. Gopal, MD、Fred Hutchinson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1999年10月1日

初级完成 (实际的)

2007年5月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2003年12月10日

首先提交符合 QC 标准的

2003年12月10日

首次发布 (估计)

2003年12月11日

研究记录更新

最后更新发布 (估计)

2015年2月5日

上次提交的符合 QC 标准的更新

2015年2月3日

最后验证

2015年2月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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