A Phase II Study of the Efficacy and Safety of Lenalidomide Plus ICE in the Treatment of Refractory and Relapsed Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
This study is to evaluate the efficacy and safety of Lenalidomide plus ICE in the treatment of Refractory and Relapsed DLBCL patients.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diffuse large B-cell lymphoma. Previously treated with 1, and only 1, chemotherapy regimen including rituximab and anthracycline. Relapse after CR, less than PR or PR to previous treatment.
- •No history of stem cell transplantation.
- •Age between 16-
- •At least 1 measurable tumor mass.
- •Minimum life expectancy of 3 months.
- •Written informed consent.
- •No history of using Lenalidomide, ifosfamide, carboplatin and etoposide.
- •No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.
排除标准
- •Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- •Clinically significant active infection.
- •Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- •Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- •Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- •Patients who are pregnant or breast-feeding.
- •HIV infection.
研究组 & 干预措施
L-ICE
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
干预措施: Lenalidomide (Drug)
L-ICE
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
干预措施: Ifosfamide (Drug)
L-ICE
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
干预措施: Carboplatin (Drug)
L-ICE
Lenalidomide 25mg/d po d1-10, Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3, Frequency every 21 days, Total cycles 4
干预措施: Etoposide (Drug)
结局指标
主要结局
Complete response rate
时间窗: 12 weeks
次要结局
- Overall survival rate(1 year)
- Overall response rate(12 weeks)
- Progression free survival rate(1 year)
- Safety as assessed using CTCAE v4.0(1 year)