Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: filgrastim (Biological)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: busulfan (Drug)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: cyclophosphamide (Drug)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: etoposide (Drug)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: melphalan (Drug)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)
Poor Risk
Primary progressive, recurrent, or resistant relapse patients
干预措施: radiation therapy (Radiation)
Good Risk
First recurrence patients
干预措施: filgrastim (Biological)
Good Risk
First recurrence patients
干预措施: busulfan (Drug)
Good Risk
First recurrence patients
干预措施: cyclophosphamide (Drug)
Good Risk
First recurrence patients
干预措施: etoposide (Drug)
Good Risk
First recurrence patients
干预措施: melphalan (Drug)
Good Risk
First recurrence patients
干预措施: autologous-autologous tandem hematopoietic stem cell transplantation (Procedure)
Good Risk
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
