EUCTR2014-000227-24-GB进行中（未招募）1 期
A Study of Thiotepa, Ifosphamide, Etoposide and Rituximab for the treatment of relapsed or refractory primary central nervous system lymphoma - TIER
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Age = 16 years of age
- •Histologically confirmed* CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) confined to the central nervous system
- •Relapsed or refractory primary central nervous system lymphoma (PCNSL) according to the following definition :
- •o one or two prior chemotherapy regimen(s), of which at least one regimen contained high-dose methotrexate at a dose of >1g/m2.
- •ECOG performance status 0,1 or 2 (or 3 if attributed to lymphoma)
- •Adequate organ function
- •o Bone marrow: platelets >80 x109/L, neutrophils >1 x109/L, haemoglobin >80 g/L
- •o Hepatic: bilirubin <1.5 x upper limit of normal (ULN) (unless isolated unconjugated hyperbilirubinaemia attributable to Gilbert’s syndrome)
- •o Renal: eGFR =40ml/min (Cockcroft-Gault)
- •o Cardiorespiratory (as judged by the Local Investigator): clinically relevant cardiac or pulmonary function tests must be performed if there is a previous history of significant cardiac or pulmonary impairment
- •Able to comply with the scanning requirements of the study
- •Valid Informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Evidence of Systemic lymphoma
- •Active infection requiring intravenous antimicrobials
- •Chemotherapy for lymphoma within 4 weeks registration
- •Whole-brain radiotherapy within 6 months of registration
- •Relapse within 1 year of a Thiotepa-based autologous stem cell transplant
- •Prior therapy with the R-IE (Rituximab – ifosphamide and etoposide) regimen with the last year
- •Evidence of HIV or Hepatitis C infection
- •Hepatitis B infection*
- •Serum albumin <25g/l
- •Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
- •Competent pPatients and competent patients with partners of childbearing potential not willing to use effective contraception during and for 12 months after therapy
研究者
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