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临床试验/NCT00004039
NCT00004039撤回2 期

Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma

Hoag Memorial Hospital Presbyterian2 个研究点 分布在 1 个国家开始时间: 1998年6月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
2

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.

详细描述

OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor response rate and duration of response for these regimens in these patients. III. Determine the failure free survival and overall survival for these patients on these regimens. IV. Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies. V. Compare the toxicities of these regimens in these patients. VI. Determine the quality of life of these patients on these regimens.

OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms: Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for this study.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other

研究点 (2)

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