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临床试验/NCT00265889
NCT00265889已完成2 期

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease

Case Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2002年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Progression-free Survival

研究概览

简要总结

RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.

详细描述

OBJECTIVES:

Primary

  • Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue).
  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk [primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).

  • Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
  • Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study.
  • First preparative regimen: Patients receive high-dose melphalan IV continuously over 16 hours on day -1.
  • First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients proceed to second preparative regimen.
  • Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over 2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second autologous SCT (day 0).
  • Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: filgrastim (Biological)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: busulfan (Drug)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: cyclophosphamide (Drug)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: etoposide (Drug)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: melphalan (Drug)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)

Poor Risk

Experimental

Primary progressive, recurrent, or resistant relapse patients

干预措施: radiation therapy (Radiation)

Good Risk

Experimental

First recurrence patients

干预措施: filgrastim (Biological)

Good Risk

Experimental

First recurrence patients

干预措施: busulfan (Drug)

Good Risk

Experimental

First recurrence patients

干预措施: cyclophosphamide (Drug)

Good Risk

Experimental

First recurrence patients

干预措施: etoposide (Drug)

Good Risk

Experimental

First recurrence patients

干预措施: melphalan (Drug)

Good Risk

Experimental

First recurrence patients

干预措施: autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)

Good Risk

Experimental

First recurrence patients

干预措施: radiation therapy (Radiation)

结局指标

主要结局

Progression-free Survival

时间窗: one year after second transplant

Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

Number of Patients That Experience Pulmonary Toxicity

时间窗: One year after second transplant

Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.

Response Rate

时间窗: One year after second transplant

Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as \>/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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