EUCTR2006-005778-34-DE进行中（未招募）1 期
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
Charité-Universitätsmedizin Berlin, Germany0 个研究点目标入组 60 人开始时间: 2007年1月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Patient > 50 years old
- •Follicular lymphoma grade I, II, or IIIa according to REAL/WHO classification
- •Ann Arbor stage III, or IV, or stage II with disseminated abdominal disease requiring extensive abdominal irradiation
- •No prior chemotherapy, immunotherapy, or irradiation
- •Lymphoma cells positive for CD20
- •Measurable disease (two perpendicular diameters by either physical or radiological examination)
- •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 < 2.500 /µl
- •Thrombocytopenia < 100.000 /µl
- •Bulk lesions > 10 cm
- •CNS lymphoma manifestation
- •Circulating tumor cells > 500 /µl
- •Extensive pleural effusion/ascites (> 1000 ml as estimated by ultrasound/CT)
- •Severe concomitant diseases (e.g. congestive heart failure, myocardial infarction within 6 months of study, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease, liver disease)
- •Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN) (unless caused by the lymphoma)
- •Abnormal renal function: serum creatinine > 2 x upper limit of normal (unless caused by the lymphoma)
- •Previous malignancy other than non-melanoma skin cancer
- •Pregnant or breast feeding female patients (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 (HAMA) reactivity
- •Severe psychiatric illness
研究者
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