Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 20
- 主要终点
- Progression free survival
研究概览
简要总结
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
详细描述
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.
The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
- •Patients no treated previously.
- •Ann Arbor Stage II, III o IV.
- •Symptoms or signes wich indicate necesary treatment (GELF criteria):
- •Ganglionar or extraganglionar mass
- •B Symptoms
- •LDH or B2-microglobuline increased
- •3 ganglionar territory afected (> 3 cm)
- •Esplenomegalia
- •Compresive syndrome
- •Pleural/peritoneal effusion
- •Secondary medular insufiency due to infiltration
- •Age> 18 years and <75 years.
- •ECOG < 2
- •Adecuate hematological function: Hemoglobin > 8,0 g/dl (5,0 mmol/L); RAN >1,5 x 109/L; platelets > 100 x 109/L
- •No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
- •Informed consent
排除标准
- •Transformation in high grade lymphoma
- •FL grade 3b.
- •Skin or gastro-intestinal primary lymphoma
- •History of CNS diseases ( or CNS lymphoma)
- •Previous treatment
- •Regulary treatment with corticosteroids (permited < 20 mg/day prednisone or equivalent).
- •Previous cancer diseases
- •Major surgery in 28 days before inclusion in study.
- •Creatinine > 2,0 mg/dl (197 mmol/L)
- •Bilirubin > 2,0 mg/dl (34 mmol/L), AST (SGOT) > 3 x upper normal limit.
- •HIV infection or active infection VHB o VHC < 4 weeks before inclusion.
- •Other complicated diseases
- •Criteria investigador:
- •Life expectancy < 6 months.
- •Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
- •Treatment in other experimental study in previous 30 days
- •Any medical o psicologycal condition that can modify the capacity to give the consent
研究组 & 干预措施
A
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
干预措施: Ibritumomab tiuxetan (Drug)
B
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years
次要结局
- Saffetty of two arms(2 years)
- Quality of life(7 years)
- Event free survival(7 years)
- Response rate in two arms(3 years)
- Global survival(7 years)