DRKS00008900已完成未知
Pilot study for a phase II trial to evaluate high-dose chemotherapy and autologous stem cell transplant in primary CNS lymphoma patients > 65 years - MARiTA - - MARiTA
Albert-Ludwigs-Universität Freiburg Medizinische Fakultät, Dekanat0 个研究点目标入组 15 人开始时间: 2016年2月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 one（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •1. Immunocompetent patients with newly-diagnosed or relapsed primary central nervous system B-cell lymphoma
- •2. Age > = 65 years as well as patients between 65 and 70 years years old, that are not eligible for treatment within the MATRix/IELSG43
- •3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.
- •4. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
- •5. Disease exclusively located in the CNS, liquor or cranial nerves
- •6. At least one measurable lesion
- •7. Cumulative Illness Rating Scale-Geriatric (CIRS-G) <6
- •8. ECOG-Performance Status = 2
- •9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease
排除标准
- •Key exclusion criteria:
- •1. Congenital or acquired immunodeficiency
- •2. Systemic lymphoma manifestation (outside the CNS)
- •3. Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord
- •4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in-situ of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years
- •5. Previous systemic Non-Hodgkin lymphoma at any time
- •6. Inadequate bone marrow (platelet count decreased =CTC grade 1, anemia =CTC grade 1, neutrophil count decreased =CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased =CTC grade 2), or hepatic function (blood bilirubin increased =CTC grade 2, alanine aminotransferase increased =CTC grade 2, aspartate aminotransferase increased =CTC grade 2 or gamma-GT increased =CTC grade 2)
- •7. HBsAg, anti-HBc or HCV positivity
- •8. HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency
- •9. Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study
- •10.Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease)
- •11. Severe non-compensated pulmonary disease (IVC <55%, DLCO <40%)
- •12.Third space fluid accumulation >500 ml
- •13.Hypersensitivity to study treatment or any component of the formulation
- •14.Taking any medications likely to cause interactions with the study medication
- •15.Known or persistent abuse of medication, drugs or alcohol
- •16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative
- •17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator
- •18.Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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