NCT00722930Unknown2 期
Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas11 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 38
- 试验地点
- 11
- 主要终点
- CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease
研究概览
简要总结
To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
- •Patients older than
- •Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
- •High-risk patients according to FLIPI before initiation of induction chemotherapy.
- •Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
- •Complete or partial response to the induction scheme.
- •ECOG scale performance status 0 -
- •Life expectancy greater than 3 months.
- •In women of childbearing age, use of a reliable contraceptive method.
- •A suitable bone marrow reserve:
- •Lower than 25% Bone marrow infiltration by lymphoma.
- •Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
- •Suitable hepatic, renal and cardiac function:
- •creatinine <2,5 x UNL (upper normality limit).
- •bilirubin or ALT/AST < 2,5 x UNL
排除标准
- •Patients with no objective clinical response to induction chemotherapy.
- •> 25% bone marrow infiltration following induction chemotherapy.
- •Platelets < 100,000 before radioimmunotherapy.
- •Severe and/or uncontrolled concomitant disease:
- •Hepatic, renal, cardiovascular, neurological or metabolic disease.
- •Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
- •Positive regarding HBV, HCV, HIV.
- •Active acute or chronic infection.
- •Social, psychic or geographic disability to satisfy any of the treatment schemes.
- •Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
- •Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).
研究组 & 干预措施
1. Consolidation with Y90 Ibritumomab Tiuxetan
Experimental
- Consolidation with Y90 Ibritumomab Tiuxetan
干预措施: Y90 Ibritumomab Tiuxetan (Drug)
结局指标
主要结局
CT scan of cervical spine, chest, abdomen and pelvis, Peripheral blood and bone marrow PCR to determine Minimal Residual Disease
时间窗: 12 weeks after consolidation, then repeated every 3 months over the first 2 years, and every 6 months thereafter
次要结局
- Objective clinical response rate (complete + partial).(3 months)
- Response conversion rate(3 months)
- Incidence of complete molecular responses(3 months)
- Response duration(36 months)
- Event-free survival.(36 months)
- Progression-free survival(36 months)
- Time to salvage therapy(36 months)
- Lymphoma-free or specific cause-free survival(36 months)
- Overall survival(60 months)
- Toxicity profile and safety of the consolidation(60 months)
研究者
研究点 (11)
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