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Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

2013年10月28日 更新者：Case Comprehensive Cancer Center

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

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

研究类型

介入性

注册 (实际的)

42

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

  • 美国
    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer 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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:

    • Disease progression during initial first line chemotherapy
    • Complete response lasting ≤ 90 days after induction
    • Partial response lasting ≤ 90 days after induction
    • First recurrence/progression with the duration of initial response ≤ 12 months after completion of chemotherapy NOTE: *There must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression
  • No clonal abnormalities in marrow collection
  • Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection

  • Must have adequate sections of original diagnostic specimen available for review

    • Needle aspirations or cytologies are not adequate
  • No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5 years)
  • No CNS involvement

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's lymphoma

Renal

  • Creatinine clearance ≥ 60 mL/min
  • Creatinine ≤ 2.0 times ULN

Cardiovascular

  • Ejection fraction ≥ 45% by 2-D echocardiogram
  • No significant active cardiac disease

Pulmonary

  • Adequate pulmonary function
  • DLCO ≥ 45%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • No known HIV or AIDS infection
  • No active bacterial, fungal, or viral infection
  • No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

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：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Poor Risk
Primary progressive, recurrent, or resistant relapse patients
生物：filgrastim
480 mcg beginning day +5
药品：busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
药品：cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
药品：etoposide
60 mg/kg, IV
药品：melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
程序：autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
辐射：radiation therapy
radiation therapy
实验性的：Good Risk
First recurrence patients
生物：filgrastim
480 mcg beginning day +5
药品：busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
药品：cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
药品：etoposide
60 mg/kg, IV
药品：melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
程序：autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
辐射：radiation therapy
radiation therapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-free Survival
大体时间：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.
one year after second transplant
Response Rate
大体时间：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.
One year after second transplant
Number of Patients That Experience Pulmonary Toxicity
大体时间：One year after second transplant
Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.
One year after second transplant

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。

赞助

Case Comprehensive Cancer Center

合作者

National Cancer Institute (NCI)

调查人员

  • 学习椅：Brian J. Bolwell, MD、Cleveland Clinic Taussig Cancer Institute

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

2002年2月1日

初级完成 (实际的)

2010年4月1日

研究完成 (实际的)

2010年4月1日

研究注册日期

首次提交

2005年12月14日

首先提交符合 QC 标准的

2005年12月14日

首次发布 (估计)

2005年12月15日

研究记录更新

最后更新发布 (估计)

2013年11月20日

上次提交的符合 QC 标准的更新

2013年10月28日

最后验证

2013年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CCF5386
  • P30CA043703 (美国 NIH 拨款/合同)
  • CCF-5386 (其他标识符：Cleveland Clinic IRB)

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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条件

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