MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with MT-R followed by autologous stem cells transplantation in newly-diagnosed primary central nervous system lymphoma.
详细描述
It's a single center, single arm, prospective clinical trial. Patients younger than 65 years old with primary central nervous system lymphoma will received four cycles of chemotherapy with rituximab plus high-dose methotrexate and temozolomide as induction therapy, and then received consolidation therapy with autologous stem cell transplant for which the conditioning regimen is Carmustine plus thiotepa.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy
- •Absence of systemic disease as evaluated by chest-abdomen-pelvis CT scan
- •Leucocytes>3.500/mm3, platelets>130.000/mm3, Bilirubin < 2 mg, transaminases < 2.5 N), creatinine < 150 μM/l, creatinine clearance > 50 ml/min/1.73m2
- •Age 18-65 years
- •Negative HIV test
- •Signature of informed consent
排除标准
- •prior chemotherapy for primary central nervous system lymphoma
- •presence of another cancer (excepting basal cell carcinoma of the skin and cervical carcinoma in situ )
- •systemic lymphoma (outside the CNS)
- •Isolated ocular lymphoma
- •Immunosuppressed patients (HIV , use of immunosuppressors)
- •Other uncontrolled or progressive disease compromising shot-term survival
- •Severe renal or hepatic disease
- •Patients not legally covered by the French Social Security
- •Inability to swallow the medication
研究组 & 干预措施
R-MT followed by auto-HSCT
R-MT followed by auto-HSCT Rituximab 375 mg/m2 d1 MTX 3.5g/m2 d2(0.5g/m2 15min,3g/m2 3h） TMZ 100 mg/m2 d2-6 Q21d*4cycles
Auto-HSCT conditioning regimen:
BCNU 400mg/m2 d1; Thiotepa 5mg/kg q12h，d2-3
干预措施: R-MT followed by auto-HSCT (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2 years
次要结局
- overall survival(2 years)
- overall response rate(2 years)
- event-free survival(2 years)
研究者
Jun Zhu
Chief of the department of lymphoma
Peking University