ACTRN12606000373572招募中3 期
A phase IV study to evaluate the treatment response (Complete Response [CR]and Partial Response [PR] of out-patient Ifosfamide, Etoposide plus Rituximab (R-IE) for salvage in patients >60 years with relapsed or refractory CD20 positive diffuse large B-cell lymphoma who are not candidates for stem cell transplant
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Roche
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Eastern Oncology Co-operative Group (ECOG) performance status 0 to 2. 2. Relapsed or progressive Cluster Designation 20 (CD20) positive diffuse large B-cell lymphoma including induction failures to first-line anthracycline-containing regimens and not usually considered eligible for high dose chemotherapy and stem cell transplantation. 3. Able to give written informed consent. 4. Life expectancy ³ 3 months
排除标准
- •1. History of severe cardiac, hepatic, respiratory, or renal disease. 2. Poor renal function (serum creatinine > 150 µmol/L or 1.5-2.0 x Upper Limit Normal (ULN), poor hepatic function (bilirubin >30 µmol/L or >1.5x ULN; transaminases>2.5 x ULN) unless these abnormalities are related to lymphoma. 3. Poor bone marrow reserve as defined by neutrophils <1.5 x 109/L or platelets <100 x 109/L unless related to bone marrow infiltration. 4. Pregnant women or breast-feeding mothers. 5. Known hypersensitivity to E coli proteins, or with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins, or to any component of the drugs being used. 6. Unable to provide written informed consent.
研究者
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