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临床试验/ISRCTN47525145
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

发起方
niversity of Heidelberg (Germany)

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