DRKS00003748已完成2 期
Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantation
niversitätsklinikum FreiburgAbt. Med 1Hämatologie / Onkologie0 个研究点目标入组 120 人开始时间: 2012年5月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 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
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •group A: first diagnosis of PCNSL, histologically confirmed
- •- group B: relapse or progression of PCNSL after MTX containing chemotherapy
- •- age 18 - 65 years
- •- not legally incompetent, physically or mentally incapable of giving consent
- •- written signed and dated informed consent of the legal representative and - if
- •possible - of the patient
排除标准
- •- Patients with manifestations of further lymphoma outside the CNS
- •- sero-positive for HIV
- •- severe pulmonary, cardiac, hepatic, renal impairment
- •Patients with the following heamtological parameters:
- •- neutrophil count < 1.500/µl, platelet count < 100.000/µl
- •- pulmonary disease with IVC < 55%, DLCO < 40%
- •- cardiac ejection fraction < 50%, uncontrolled malign arrhythmia
- •- creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- •- bilirubin > 2mg/dl
- •- ascites or pleural effusion (> 500ml)
- •- pregnancy o r lactation
- •- women with childbearing potential without sufficient contraception
- •- participation in another clinical trial within the last 30 days prior to the begin or
- •parallel to this study
- •- known or current drug, medicinal drug or alcohol abuse
- •- known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab,
- •leukovorin, dexamethasone, neupogen and neulasta.
研究者
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