A Pilot Phase II Study Of Sequential Treatment With Chemotherapy, Radioimmunotherapy and Autologous Hematopoietic Stem Cell Transplantation in Patients With Follicular Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Disease-free survival percentage(intention to treat)
研究概览
简要总结
Follicular lymphoma has historically been considered an incurable lymphoma. By combining multiple effective treatments, the investigators believe that prolonged disease-free survival is achievable in this disease. The investigators goal is to have at least 60-70% of our patients in first continuous complete remission 15 years from initiation of treatment.
详细描述
Patients will receive six cycles of combination chemotherapy, C-MOPP-R, typically through a subcutaneous PORT. This combination chemotherapy will last six months. After the last dose of chemotherapy, patients will have a 2 month treatment holiday prior to undergoing stem cell mobilization from peripheral blood with subcutaneous injections of neupogen and mozobil. Patients then receive Zevalin radioimmunotherapy, and this is followed after recovery of blood counts, typically 3 months later, by an autologous stem cell transplant.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years of age
- •Follicular lymphoma, newly diagnosed or previously treated but no more than 2 previous regimens
- •Relapse of disease must be greater than 6 months after last chemotherapy
- •Stages II, III or IV
- •Eastern Cooperative Group (ECOG) performance status of 0 or
- •If ECOG 2-4, poor performance must by due to lymphoma as judged by study investigator.
- •Patient signed written informed consent
- •Adequate renal function defined as a glomerular filtration rate (GFR) > 60 ml/min
- •Adequate blood counts (absolute neutrophil count ≥ 1,500, platelets ≥100,000), unless low due to lymphomatous involvement of the bone marrow.
- •No known allergies to the chemotherapeutic agents
- •No other major disabling co morbidities
- •Adequate pulmonary function, defined as corrected DLCO greater than 70% of predicted and FEV1 (forced expiratory volume in one second, a test of respiratory function) greater than 50% of predicted.
- •Adequate hepatic function as assessed by study investigator
- •Adequate cardiac function, defined as baseline MUGA (Multiple gated acquisition, a test of heart function) >50%
排除标准
- •Stage I follicular lymphoma
- •ECOG performance status ≥ 2, unless due to lymphoma
- •Patient refuses to sign written informed consent
- •Poor renal function defined as GFR <60ml/min
- •Abnormal liver function as assessed by study investigator
- •Poor bone marrow reserve (absolute neutrophil count <1,500 and/or platelets < 100,000) not attributable to lymphomatous involvement of the bone marrow.
- •Hypersensitivity to the chemotherapeutic agents
- •Major disabling co morbidities like uncontrolled severe HTN (hypertension), active coronary artery disease, liver cirrhosis.
- •Previously diagnosed malignancy other than basal or squamous cell carcinoma of the skin diagnosed <5 years prior.
- •Central nervous system disease
- •History of advanced cardiac disease (Active angina, Congestive heart failure with a LVEF (left ventricular ejection fraction) <50%).
结局指标
主要结局
Disease-free survival percentage(intention to treat)
时间窗: 5 years
次要结局
- Incidence of second malignancies(5 years)