A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
研究概览
简要总结
This is a Phase II trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.
详细描述
Lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. A variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. Furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. During 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. Over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. We now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •age > 18 years
- •relapsed or primary refractory non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease (HD)
- •ECOG 0 - 2
- •written informed consent
- •Exclusion criteria:
- •Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy
- •bilirubin > 50μmol/litre unless secondary to lymphoma
- •creatinine > 2 x upper limit of normal unless secondary to lymphoma, absolute neutrophil count <0.5 x 109/litre and / or platelets < 50 x 109/litre unless secondary to lymphoma
- •relapse within 6 months of a prior transplant procedure (autologous or allogeneic)
- •known sensitivity to E coli derived preparations
排除标准
- 未提供
研究组 & 干预措施
Commence VGF treatment
Drug. Vinorelbine, gemcitabine and filgrastim 21 day cycle
干预措施: gemcitabine, vinorelbine, filgastrim (Drug)
Commence F-GIV treatment
Drug. Gemcitabine, ifosfamide, Vinorelbine and filgrastim 21 day cycle
干预措施: gemcitabine, vinorelbine, ifosfamide, filgastrim (Drug)
结局指标
主要结局
To evaluate the efficacy (overall response rate) of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim).
时间窗: After two cycles and after four cycles
次要结局
- To evaluate safety,(Days 1 and 8 for every cycle, days 10,12,14, and 16 for first cycle.)
- relapse free survival,(After 2 cycles, 4 cyles and every 3 or 4 months for 12 months. Then every 6 months until disease progression)
- overall survival,(every 3 or 4 months for 12 months. Then every 6 months.)
- and planned dose-on-time.(After two cycles and after four cycles)