Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
- Determine the toxicity of this regimen in these patients.
- Determine the time to progression and survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.
Patients are followed every 1-2 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)
- •Previously untreated
- •More than 1 of the following criteria:
- •Prior diagnosis of AIDS
- •ECOG performance status 3-4
- •CD4 count less than 100/mm3
- •No primary cerebral lymphoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •See Disease Characteristics
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for HIV-NHL
- •At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy for HIV-NHL allowed
- •At least 1 year since prior radiotherapy for KS
- •Not specified
排除标准
- 未提供