A study of thiotepa, ifosphamide, etoposide and rituximab for the treatment of relapsed or refractory primary central nervous system lymphoma

niversity of Birmingham0 个研究点目标入组 36 人开始时间: 2014年12月3日最近更新: 2023年2月27日

适应症

试验速览

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34464973/ (added 15/02/2023)

•1 Age = 16 years of age
•2. Histologically confirmed* CD20+ Diffuse Large B Cell Lymphoma (DLBCL) confined to the central nervous system
•3. Relapsed or refractory primary central nervous system lymphoma (PCNSL) according to the following definition :
•3.1. One or two prior chemotherapy regimen(s), of which at least one regimen contained highdose
•methotrexate at a dose of >1g/m2.
•3.2. Minimum of one cycle containing highdose methotrexate
•4. ECOG performance status 0,1 or 2 (or 3 if attributed to lymphoma)
•5. Adequate organ function:
•5.1. Bone marrow: platelets >80 x109/L, neutrophils >1 x109/L, haemoglobin >80 g/L
•5.2. Hepatic: bilirubin <1.5 x upper limit of normal (ULN) (unless isolated unconjugated hyperbilirubinaemia attributable to Gilbert’s syndrome)
•5.3. Renal: eGFR =40ml/min (Cockcroft-Gault)
•5.4. 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
•6. Able to comply with the scanning requirements of the study
•7. Valid Informed consent

•1. Systemic involvement with lymphoma
•2. Active infection requiring intravenous antimicrobials
•3. Chemotherapy for lymphoma within 4 weeks registration
•4. Wholebrain radiotherapy within 6 months of registration
•5. Relapse within 1 year of a Thiotepabased autologous stem cell transplant
•6. Prior therapy with the RIE (Rituximab – ifosphamide and etoposide) regimen
•7. Evidence of HIV or Hepatitis C infection
•8. Hepatitis B infection*
•9. Serum albumin <25g/l
•10. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)
•11. Competent pPatients and competent patients with partners of childbearing potential not willing to use effective contraception during and for 12 months after therapy

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