EUCTR2006-004093-27-HU进行中（未招募）1 期
A multicenter, phase II, open-label study evaluating the benefit of addition of MabThera (rituximab) to standard chemotherapies in patients with previously untreated mantle cell lymphoma. - REMENY
Roche (Hungary) Ltd.0 个研究点目标入组 50 人开始时间: 2007年2月15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
- 50
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
- •1.Written and signed informed consent according to ICH/EU GCP and national/local regulations
- •2. Male or female patients
- •3.Age >18 years.
- •4.Histologically proven mantle cell lymphoma: MCL must be proven by a histological examination of representative material (e.g. lymph node or bone marrow) within 4 weeks before induction of treatment. Cyclin D1 posititivity or t(11;14)(q13;q32) is desirable but not essential for diagnosis.
- •5.Material (lymph node or bone marrow biopsy) must be available for possible farther review
- •6.Previously untreated disease at stage II, III and IV, requiring therapy
- •7.Life expectancy of at least 6 months
- •8.Pre-study performance status ECOG 0, 1 or 2 (see Appendix)
- •9.Women of childbearing potential must agree to follow accepted birth control methods during the trial
- •10.Men must agree to follow accepted birth control methods during the trial in order not to father a child
- •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
- •1.Known hypersensitivity reaction to rituximab, known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies, or standard chemotherapy compounds or incorporated substances
- •2.Previous treatment with rituximab
- •3.Platelet count < 100 x 103 /mm3, WBC < 3.0 x 103 /mm3, unless clearly related to MCL bone marrow infiltration
- •4.Patients with stage I disease
- •5.Patients with central nervous system involvement
- •6.Patients with a history of autoimmune hemolytic anemia or autoimmune thrombocytopenia
- •7.Active malignancy other than MCL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, sqamous cell carcinoma of the skin, or in situ malignancy
研究者
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