NCT00147121已完成2 期
Rituximab + Standard CHOP (R･S-CHOP) vs Rituximab+ Bi-weekly CHOP (R･Bi-CHOP) RCT(Phase II/III) for Stage III/IV Low-grade B-cell Lymphoma (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
Haruhiko Fukuda45 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2002年9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
- 300
- 试验地点
- 45
- 主要终点
- CR rate (phase II)
研究概览
简要总结
To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma
详细描述
Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
- •CD20-positive
- •Ann Arbor CS III or IV
- •Lymphoma cell count in PB≦10,000/mm3
- •20<=age<=69
- •ECOG PS 0-2
- •Bidimensionally measurable disease >1.5cm in a single dimension by CT scans
- •No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
- •Normal BM, hepatic, renal, cardiac, and pulmonary function
- •Written informed consent
排除标准
- •CNS involvement
- •DM treated by insulin
- •Uncontrollable HT
- •Positive HBs antigen
- •seropositive to HCV
- •seropositive to HIV
- •Interstitial pneumonitis, pulmonary fibrosis, or emphysema
- •Severe infection
- •Liver cirrhosis
- •Double cancer
- •Pregnant or lactating
- •Patients who desire auto PBST after CR
- •Patients treated with major tranquilizer or antidepressant
研究组 & 干预措施
1
Active Comparator
Rituximab+Standard CHOP
干预措施: Rituximab + Standard CHOP (Drug)
2
Experimental
Rituximab+bi-Weekly CHOP
干预措施: Rituximab + Bi-weekly CHOP (Drug)
结局指标
主要结局
CR rate (phase II)
时间窗: during the study conduct
PFS (phase III)
时间窗: during the study conduct
次要结局
- ORR, PFS, OS, Safety (phase II)(during the study conduct)
- OS, Safety (phase III)(during the study conduct)
研究者
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group
研究点 (45)
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