Prospective Identification of Significant Prognostic Factors in Patients Treated With Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- Number of Participants With Complete Remission (CR)
研究概览
简要总结
The goal of this clinical research study is to learn more about the characteristics of CLL, including genes and chromosome abnormalities and proteins expressed by the leukemia cells, which may help doctors predict if patients who receive standard treatment (fludarabine, cyclophosphamide, and rituximab) for the first time will experience a complete remission.
详细描述
The Study Drugs:
Fludarabine is designed to make cancer cells less able to repair damaged DNA (the genetic material of cells). This may increase the likelihood of the cells dying.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Rituximab is designed to attach to lymphoma cells, which may cause them to die.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will have a diagnosis of CLL, Small Lymphocytic Lymphoma (SLL), or CD20 positive low-grade lymphoproliferative disorder.
- •All patients with untreated Rai stage III-IV are eligible for this protocol. Prior treatment with single-agent rituximab permitted. OR Patients with untreated Rai stage 0-II who meet one or more criteria for active disease as defined by the International Working Group for CLL (IWCLL). Prior treatment with single-agent rituximab permitted.
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients must have adequate renal and hepatic function (creatinine <2mg%, bilirubin <2mg%). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman.
- •Patients may not receive other concurrent chemotherapy, radiotherapy, or immunotherapy. Localized radiotherapy to an area not compromising bone marrow function does not apply.
- •Patients must be 16 years of age or older.
- •Patients must sign informed consent indicating that they are aware of the investigational nature of this study according to the policies of the MD Anderson Cancer Center Institutional Review Board (MDACC IRB).
排除标准
- 未提供
研究组 & 干预措施
Fludarabine, Cyclophosphamide, Rituximab
Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
干预措施: Fludarabine (Drug)
Fludarabine, Cyclophosphamide, Rituximab
Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
干预措施: Cyclophosphamide (Drug)
Fludarabine, Cyclophosphamide, Rituximab
Fludarabine 25 mg/m^2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Cyclophosphamide 250 mg/m2 given intravenously on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2 and beyond. Rituximab 375 mg/m2 given intravenously on Day 1 of Course 1
All subsequent Courses: 500 mg/m2 given intravenously on Day 1 (Weeks 5,9,13,17,21)
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants With Complete Remission (CR)
时间窗: After 6 months
Complete Response defined by NCI Working Group / International Working Group for CLL criteria as no evidence of disease on physical examination (no adenopathy or organomegaly) or microscopic examination of blood (ALC \<4,000/L) and bone marrow (\<30% lymphocytes, no lymphoid nodules), and recovery of hemoglobin, neutrophil, and platelet counts.
次要结局
未报告次要终点