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Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

2013年7月10日 更新者:Fox Chase Cancer Center

Phase II Study of Epirubicin and Rituximab in Relapsed and Refractory B-Cell Non-Hodgkin's Lymphoma and CLL

RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining epirubicin with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with rituximab in treating patients who have relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

研究概览

详细说明

OBJECTIVES:

  • Determine the response rate, time to progression, and overall survival of patients with refractory or relapsed B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with epirubicin and rituximab.
  • Determine the toxicity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a non-randomized, open-label, multicenter study.

Patients receive epirubicin IV over 3-5 minutes once weekly for 6 weeks. Patients also receive rituximab IV on weeks 2 and 5 during course 1 and then on weeks 1 and 4 for all remaining courses. Treatment repeats every 8 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study within 2.5-3 years.

研究类型

介入性

注册 (实际的)

5

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19111
        • Fox Chase 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

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed B-cell non-Hodgkin's lymphoma (any grade) or chronic lymphocytic leukemia meeting 1 of the following criteria:

    • Primary refractory disease
    • Disease progression after at least 1 but no more than 4 prior cytotoxic chemotherapy regimens

      • Rituximab administered alone is not considered 1 prior regimen
      • High-dose chemotherapy with stem cell support is considered 1 prior regimen
  • Bidimensionally measurable or evaluable disease outside prior irradiation port
  • No clinical evidence of CNS involvement

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 2,000/mm^3*
  • Platelet count at least 100,000/mm^3* NOTE: *Unless due to bone marrow involvement

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2 times upper limit of normal (ULN)

Renal

  • Creatinine no greater than 2 times ULN

Cardiovascular

  • No unstable angina
  • No uncontrolled congestive heart failure
  • LVEF at least 45%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study treatment
  • HIV negative
  • No other concurrent primary malignancy except basal cell or squamous cell skin cancer, carcinoma in situ, or localized solid tumors cured more than 5 years ago
  • No acute infection requiring systemic therapy
  • No confusion, disorientation, or major psychiatric illness that would preclude understanding of informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • At least 4 weeks since prior biologic therapy

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • Prior cumulative doxorubicin dose no greater than 6 courses at 50 mg/m^2

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy to the entire pelvis
  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • More than 7 days since prior cimetidine
  • No concurrent cimetidine

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
  • 屏蔽:无(打开标签)

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。

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

2003年3月1日

初级完成 (实际的)

2005年8月1日

研究完成 (实际的)

2005年8月1日

研究注册日期

首次提交

2003年6月5日

首先提交符合 QC 标准的

2003年6月5日

首次发布 (估计)

2003年6月6日

研究记录更新

最后更新发布 (估计)

2013年7月11日

上次提交的符合 QC 标准的更新

2013年7月10日

最后验证

2013年7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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