Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide and Decadron (VRCD Regimen) in Front-line Therapy of Patients With Low-grade Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
研究概览
简要总结
Overall response rate and Time to disease progression using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma.
详细描述
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Small Lymphocytic Lymphoma
- •Follicular Cell Lymphoma (grades I and II)
- •Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
- •Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
- •Marginal Zone Lymphoma
- •MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
- •Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
- •ECOG performance status of 0, 1, or 2
- •Able to read, understand, and sign an IRB approved informed consent
排除标准
- •Known HIV positive status
- •Known CNS involvement
- •Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
研究组 & 干预措施
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
干预措施: VELCADE® (Drug)
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
干预措施: Rituximab (Drug)
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
干预措施: Cyclophosphamide (Drug)
Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
干预措施: Decadron (Drug)
结局指标
主要结局
Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
时间窗: 4 years
Percentage of complete responders plus percentage of partial responders equals overall response rate.
次要结局
- Overall Survival(4 years)
研究者
Dr. Sigrun Hallmeyer
Director of Research
Oncology Specialists, S.C.