A Pilot Study of Cyclophosphamide/Pegylated Liposomal Doxorubicin/Vincristine/Prednisone (CDOP) Plus Rituximab for Treatment of Elderly Patients With Previously Untreated Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
研究概览
简要总结
Currently there is no one standard of care for older patients with Non-Hodgkin's Lymphoma (NHL). The study will examine the tolerability and feasibility to the combination of Cyclophosphamide, Pegylated Liposomal Doxorubicin, Vincristine, Prednisone (CDOP) plus Rituximab.
详细描述
Elderly NHL patients tend to tolerate the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) less well when compared to the younger population. Cardiotoxicity, as well as neutropenia, are the most common side effects in the elderly population with age being a risk factor for doxorubicin induced cardiac toxicity. Treatment related toxicity in the older population can preclude adequate therapy and potentially contribute to poor outcomes. Pegylated liposomal doxorubicin has shown similar efficacy with a significant lower incidence of cardiotoxicity ad significantly fewer cardiac events compared with conventional doxorubicin. Exploration of alternative regimens to maximize tolerability and thus enhance overall efficacy in this population is warranted. Both safety and efficacy will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years and older;
- •Diagnosis of Non-Hodgkin's lymphoma where therapy with CHOP plus rituximab is considered;
- •Previously untreated;
- •Adequate renal and hepatic functions;
- •Cardiac ejection fraction at least 50% by MUGA. No significant cardiac abnormalities by EKG;
- •Signed informed consent
排除标准
- •CNS involvement by lymphoma;
- •Hypersensitivity to study drugs;
- •Active infection;
- •Prior treatment with monoclonal antibodies for cancer;
- •History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
结局指标
主要结局
To evaluate the feasibility and tolerability of CDOP plus rituximab in elderly patients with previously untreated NHL.
次要结局
- duration of response
- median time to disease progression
- overall survival
- Tumor response