A Phase II Study of the Efficacy and Safety of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB 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 non-GCB subtype. Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. Relapse after CR, less than PR or PR to previous treatment.
- •No history of stem cell transplantation, and no intention for stem cell transplantation.
- •Age between 16-
- •At least 1 measurable tumor mass.
- •Minimum life expectancy of 3 months.
- •Written informed consent.
- •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
V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
干预措施: Bortezomib (Drug)
V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
干预措施: Gemcitabine (Drug)
V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
干预措施: Dexamethasone (Drug)
V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
干预措施: Cisplatin (Drug)
结局指标
主要结局
Response rate
时间窗: Every 2 cycles during treatment and then every 3 months for 2 years
28 days as one cycle
次要结局
- Progression free survival(1 year)
- Overall survival(1 year)
- Safety as assessed using the CTCAE(Days 1 of each course and 4-6 weeks after final treatment)