NCT01148173Unknown2 期
Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to treatment failure
研究概览
简要总结
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
- •CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
- •ECOG performance score ≤2
- •no active infection
- •negative HIV-serology
- •adequate renal function (creatinine clearance > 50 ml/min)
- •adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)
- •normal bilirubin, AST < 3 x UNL
- •negative pregnancy test
排除标准
- •newly diagnosed NHL with primary CNS involvement
- •indolent NHL, lymphoblastic NHL or Burkitt lymphoma
- •preceding CNS irradiation
- •pretreatment of CNS relapse other than corticosteroids
- •immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
- •second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
- •unfit to receive an intensive chemotherapy
- •pregnancy or breastfeeding
- •known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
研究组 & 干预措施
Systemic and intrathecal chemotherapy
Experimental
干预措施: Combined systemic and intrathecal chemotherapy followed by HD-ASCT (Drug)
结局指标
主要结局
Time to treatment failure
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Remission rate(3 months)
- Toxicity(1 year)
研究者
研究点 (1)
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