EUCTR2006-002141-37-NL进行中（未招募）不适用
Phase II study on the feasibility and efficacy of R-DHAP + HD-MTX, combined with intrathecal rituximab, followed by autologous stem cell transplantation in patients with a recurrent aggressive B-cell lymphoma with CNS localisation - HOVON 80 NH
HOVON foundation0 个研究点目标入组 35 人开始时间: 2006年7月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
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
- •*Diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification (see appendix A):
- •-Follicular lymphoma grade III
- •-Diffuse large B-cell lymphoma
- •Prior low-grade” lymphoma with histologically proven transformation to follicular lymphoma grade III or DLBCL is also permitted.
- •*CD 20 positive
- •*First progression or relapse with CNS localisation (see below) without or with systemic relapse (preferably histologically proven). ‘Progressive’ includes patients who have progressive disease (PD), without prior response and patients who have progression after first PR.
- •*Diagnosis of CNS localisation based on at least one of the following:
- •-Unequivocal morphological and/or immunophenotypical evidence of CSF lymphoma
- •-clinical AND MRI evidence of leptomeningeal localisation
- •-brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma, concurrently with systemic progression or recurrence
- •-biopsy-proven brain parenchymal NHL localisation of previously diagnosed systemic NHL
- •*Age 18-65 years inclusive
- •*WHO performance status 0 – 2 (see appendix F) with or without administration of steroids
- •*Witnessed written informed consent according to the centre’s requirements
- •*Negative pregnancy test in women of reproductive potential
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •*History of intolerance of exogenous protein administration
- •*Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%)
- •*Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value) unless clearly related to NHL involvement
- •*Hepatic dysfunction, bilirubin or transaminase = 2.5 x upper normal limit, unless related to lymphoma.
- •*Renal dysfunction (serum creatinine =150 umol/l or clearance = 60 ml/min)
- •*Prior cranial radiotherapy
- •*Active uncontrolled infection
- •*Known HIV-positivity
- •*(EBV) post-transplant lymphoproliferative disorder
- •*Documented CNS involvement during 1st line therapy (MTX intrathecal profylaxis during 1st line therapy is no exclusion criterium)
研究者
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