ISRCTN47525145已完成不适用
Standard chemotherapy combination (Cyclophosphamide, Hydroxydaunorubicin, Vincristine, Prednisolone [CHOP]) with 1, 3 or 6 cycles of the monoclonal anti-CD20-antibody. Rituximab in first line therapy of follicular non-Hodgkin?s lymphoma.
niversity of Heidelberg (Germany)0 个研究点目标入组 120 人开始时间: 2006年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with histologically proven CD20+ follicular lymphoma (follicular lymphoma grade I, II), stage III and IV
- •2. Age >18 years, no upper limit
- •3. No pre-treatment except irradiation and/or corticosteroids
- •4. Requirement of therapy: one or more of the following: B-symptoms, hematopoietic insufficiency (leukopenia <1.5/nl, anemia hb <10 g/dl, platelets <100/nl)
- •5. Objective tumor progression (>50% increase in sum of tumor diameters in six months); 'bulky disease' (mediastinal/abdominal tumor >7.5 cm and/or other lymphnodes >5 cm)
排除标准
- •1. Age <18 years
- •2. Stage I or II
- •3. CD20 negativity
- •4. Karnofsky Index <80% or Eastern Cooperative Oncology Group (ECOG) >2
- •5. Pre-treatment with murine antibodies, severe organ impairment (heart, lung, neck) according to common criteria
- •6. Pre-treatment with any chemotherapy
研究者
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