EUCTR2006-001888-40-CZ进行中（未招募）不适用
A phase II prospective non-comparative multicenter clinical trial to determine the efficacy and safety of intrathecal liposomal cytarabine (DepoCyte®) in preventing CNS-relapse in patients with aggressive Non-Hodgkin-Lymphomas at risk for CNS metastasis. - CNS Prophylaxis with DepoCyte® in Aggressive NH
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •- Informed consent
- •- Male and female, age = 18 years
- •- Histological proven aggressive Non-Hodgkin-Lymphoma at risk and eligible for R-CHOP therapy (newly diagnosed patients) respectively R-ICE therapy (systemically relapsed patients) and
- •A. ONE of the following extranodal sites:
- •* Testis involvement
- •* High cervical involvement (nasal/paranasal sinuses, orbita, epidural space, parotid and submandibular glands, ear, throat region)
- •* Bone marrow involvement
- •AND ONE of the following risk factors:
- •* Extranodal sites > 1
- •* LDH > 450 U/l
- •B. Both of the following risk factors:
- •* Extranodal sites > 1
- •* LDH > 450 U/l
- •- Negative CSF-cytology
- •- Karnofsky = 60%
- •- Females of child-bearing potential must have a negative (urine or serum) pregnancy test and effective methods to prevent pregnancy.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Histology of lymphoma not eligible for R-CHOP or R-ICE treatment
- •- Uncontrolled infection including HIV infection
- •- Any previous CNS tumor therapy
- •- Known or suspected CNS metastasis
- •- Previous history of any CNS disease or present condition which is regarded as contraindication for intrathecal chemotherapy
- •- Patients unable to comply with trial procedures
- •- Pregnancy and lactation
- •- Any other investigational drug within 21 days prior to trial entry
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