EUCTR2006-005778-34-SE进行中（未招募）不适用
Multicenter European pilot study of 90Yttrium-ibritumomab tiuxetan as first line therapy for stage III-IV follicular lymphoma (and selected patients with extended stage II) followed by consolidation Rituximab for patients in complete remission but with persistent molecular disease. - Zevalin first line in Follicular lymphoma
Charite-Universitätsmedizin Berlin Germany0 个研究点目标入组 60 人开始时间: 2007年4月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients > 18 years old
- •-Follicular lymphoma grade I,II or IIIa according to REAL/WHO calssification
- •- -Ann Arbor stage III or IV or II with disseminated abdominal disease requiring extensive abdominal irradiation
- •- No prior chemotherapy, immunotherapy or irradiation
- •-Lymphoma cells positive for CD20
- •- Measurable disease
- •-WHO/ECOG performance status 0-2
- •-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Bone marrow involvement only
- •-Bone marrow infiltration>25%
- •-Leukocytopenia<2500/microlitre
- •-Thrombocytopenia<100 000/microlitre
- •-Bulk lesions>10 cm
- •-CNS lymphoma manifestation
- •-Circulating tumor cells>500/micrilitre
- •-Extensive pleural effusion/ascites(>1000 ml as estimated by ultrasound /CT)
- •Severe concomitant disease(e.g. congestive heartfailure, myocardial infarction within 6 months of studystart, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease,liver disease)
- •-Abnormal liver function:transaminases or total bilirubin>2 x upper limit of normal(unless caused by the lymphoma)
- •-Abnormal renal function:serum creatinine >2 x upper limit of normal (unless caused by the lymphoma)
- •-Previous malignanacy other than non melanoma skin cancer
- •-Pregnant or breastfeeding (negative pregnancy test required for women of fertile age), no effective contraception
- •-HIV positivity
- •-Known hypersensitivity to foreign proteins, murine antibodies, presence of human anti-murine antibodies reactivity
- •-Severe psychiatric illness
研究者
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