A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 43
- 主要终点
- Complete Response Rate
研究概览
简要总结
This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years or older
- •Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades 1or 2 according to the World Health Organization classification
- •Subjects must have received at least 12 doses (375mg/m2 or appropriately adjusted dose) of rituximab for the treatment of this lymphoma as single agent rituximab or in rituximab-containing regimens as documented in the subject's medical record
- •Documented relapse or progression following last antineoplastic treatment
- •At least 1 measurable tumor mass (≥1.5 cm x ≥1.0 cm)
排除标准
- •Subjects with histological or clinical transformation to an aggressive lymphoma
- •prior treatment with VELCADE or fludarabine.
- •antineoplastic (including unconjugated therapeutic antibodies), experimental, or radiation therapy within 3 weeks before randomization
- •nitrosoureas within 6 weeks before randomization
- •radioimmunoconjugates or toxin immunoconjugates within 10 weeks before randomization
- •major surgery within 3 weeks before randomization
- •chronic use of corticosteroids, such as dexamethasone
研究组 & 干预措施
fludarabine and rituximab (Group B)
fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
干预措施: fludarabine (Drug)
VELCADE and fludarabine (Group A)
VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
干预措施: fludarabine (Drug)
VELCADE and fludarabine (Group A)
VELCADE 1.6 mg/m2 intravenously (IV) on Days 1, 8, 15, and 22 and fludarabine 40mg/m2/day orally on Days 1 to 5 of every 35-day cycle
干预措施: VELCADE (Drug)
fludarabine and rituximab (Group B)
fludarabine 40mg/m2/day orally on Days 1 to 5 and rituximab 375mg/m2 on Day 1 of every 35-day cycle
干预措施: rituximab (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: Up to 8 cycles (1 cycle is 35 days: 280 days)
The proportion of response-evaluable subjects who achieved a confirmed complete response (CR) or complete response unconfirmed (CRu). Disease response and progression were evaluated according to modified International Workshop Response Criteria (IWRC) criteria by radiographic imaging and other procedures as necessary.
次要结局
- Overall Response Rate(Up to 8 cycles (1 cycle is 35 days: 280 days))