EUCTR2005-005218-19-DK进行中（未招募）1 期
Randomised Study Comparing an Immuno-Chemotherapy with 6 Cyclesof the Monoclonal anti-CD20 Antibody Rituximab in Combination with6 Cycles of Chemotherapy with CHOP (Cyclophosphamide, Doxorubicin, Vincristine,and Prednisone) at 21-day Intervals or 14-day Intervals, both with or withoutconsolidating Radiotherapy of Large Tumour Masses (= 7.5 cm) and/orExtranodal involvement in Patients with Aggressive CD20+ B-Cell LymphomaAged 18 to 60 Years with Age-adjusted IPI=1 (all) or IPI=0 withBulky Disease (= 7.5 cm) Short Title: UNFOLDER 21/14 Study - UNFOLDER 21/14 study
German High Grade Non-Hodgkin's Lymphoma group0 个研究点目标入组 1,072 人开始时间: 2007年7月10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
- 1,072
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
- •18 to 60 years
- •2.Risk group:
- •good-prognosis, less favourable
- •1.(age-adjusted) IPI=1: all patients
- •2.(age-adjusted) IPI=0: only patients with bulky disease (for definitions see Appendix 13.9, largest single or conglomerate tumour must be = 7.5 cm in diameter)
- •3.Histology:
- •Diagnosis of a untreated CD20-positive aggressive B-cell lymphoma, confirmed by excisional biopsy of a lymph node or by a sufficiently extensive biopsy of extranodal manifestation if there is no lymph node involvement. It will be possible to treat the following entities in this study:
- •follicular lymphoma stage III°b
- •follicular lymphoma stage III° and diffuse large B-cell lymphoma
- •diffuse large B-cell lymphoma
- •centroblastic
- •immunoblastic
- •plasmoblastic
- •anaplastic large cell
- •T-cell-rich B-cell lymphoma
- •primary effusion lymphoma
- •intravasal B-cell lymphoma
- •primary mediastinal B-cell lymphoma
- •Burkitt-like lymphoma
- •Burkitt lymphoma
- •aggressive marginal zone lymphoma (monocytoid)
- •Mantle-cell lymphoma (blastoid)
- •4.Performance status:
- •Performance status ECOG 0-2 at the time of randomisation.
- •5.Declaration of participation provided by the study centre and the written consent by the patient
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Already initiated lymphoma treatment (except for prephase treatment according to this protocol)
- •2.Serious accompanying disorder or impaired organ function (in particular impaired left ventricular function or severe cardiac arrhythmias)
- •3.Platelets < 100 000/mm3, leukocytes < 2 500/mm3
- •4.Known hypersensitivity to the medications to be used
- •5.Known HIV-positivity
- •6.Active hepatitis infection
- •7.Suspected poor patient compliance
- •8.Simultaneous participation in other treatment studies
- •9.Prior chemo- or radiotherapy for previous disorder
- •10.Prior immunosuppressive treatment with cytostatics
- •11.Other concomitant tumour disease and/or tumour disease in the past 5 years (except carcinoma in situ and basalioma of the skin)
- •12.Pregnancy and lactation period
- •13.>1 Risk factor according to age-adjusted IPI (LDH >UNV, stage III/IV, ECOG >1)
- •14.CNS involvement of lymphoma (intracerebral, meningeal, intraspinal)
- •15.MALT lymphoma
- •16.Non-application of inclusion criteria.
- •Patients with primary CNS involvement or MALT lymphoma should not be included in this study.
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