NCT00556127已完成2 期
Programma di Terapia Per Pazienti Affetti da Linfoma Diffuso a Grandi Cellule B CD20 Positive
Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie14 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2002年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 14
- 主要终点
- Failure-free survival
研究概览
简要总结
The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previously untreated aggressive B-cell lymphoma (Diffuse Large B-Cell,
- •Primary Mediastinal,
- •Follicular grade III b Lymphoma);
- •age 18 to 60;
- •III-IV Ann Arbor stage;
- •0-2 Eastern Cooperative Oncology Group (ECOG) performance status (PS);
- •intermediate-high (IH) and high (H) risk score according to age-adjusted International Prognostic Index (IPI).
- •Patients with Primary Mediastinal Lymphoma were included only if they had advanced stage III or IV disease.
排除标准
- •hepatitis B or C virus seropositivity;
- •CNS involvement at diagnosis;
- •abnormal renal, pulmonary and hepatic function;
- •left ventricular ejection fraction less than 45%;
- •pregnancy.
研究组 & 干预措施
1
Experimental
干预措施: Rituximab (Drug)
1
Experimental
干预措施: Epirubicin (Drug)
1
Experimental
干预措施: Cyclophosphamide (Drug)
1
Experimental
干预措施: Vincristine (Drug)
1
Experimental
干预措施: Prednisone (Drug)
1
Experimental
干预措施: Granulocyte-colony-stimulating factor (Drug)
1
Experimental
干预措施: Mitoxantrone (Drug)
1
Experimental
干预措施: Cytarabine ARA-C (Drug)
1
Experimental
干预措施: Dexamethasone (Drug)
1
Experimental
干预措施: Carmustine BCNU (Drug)
1
Experimental
干预措施: Etoposide (Drug)
1
Experimental
干预措施: Melphalan (Drug)
1
Experimental
干预措施: Radiotherapy (Radiation)
1
Experimental
干预措施: PBSC reinfusion (Procedure)
结局指标
主要结局
Failure-free survival
时间窗: Three years
次要结局
未报告次要终点
研究者
研究点 (14)
Loading locations...
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