Randomised phase II trial on primary chemotherapy with high-dose Methotrexate and high-dose Cytarabine with or without Thiotepa, and with or without Rituximab, followed by brain irradiation vs high-dose chemotherapy supported by autologous stem cells transplantation for immunocompetent patients with newly diagnosed Primary CNS Lymphoma. - IELSG 32

niversity Hospital Southampton NHS Foundation Trust0 sites126 target enrollmentMarch 30, 2011

Overview

No summary available.

Registry

who.int

Start Date

March 30, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Southampton NHS Foundation Trust

•Histological or cytological assessed diagnosis of non\-Hodgkin's lymphoma. • Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. • Disease exclusively localized into the central nervous system, CSF, cranial nerves or eyes. • At least one measurable lesion. • Previously untreated patients (previous or ongoing steroid therapy admitted). • Age 18\-65 years (with ECOG Performance Status 0\-3\) or 66\-70 (with ECOG Performance Status 0\-2\). • Adequate bone marrow (PLT \= 100000 mm3, Hb \=?9 g/dl, ANC \=?2\.000 mm3\), renal (creatinine clearance \=?60 ml/min), cardiac (VEF \=?50%), and hepatic function (total serum bilirubin \= 3 mg/dL, AST/ALT and ?GT \= 2 per upper normal limit value). • Sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation. • Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow\-up schedule. • Patient\-signed informed consent obtained before registration
•Are the trial subjects under 18? no
•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 0
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 0

•Patients with lymphomatous lesions outside the CNS. • Patients with a previous non\-Hodgkin lymphoma at any time. • Previous or concurrent malignancies with the exception of surgically cured carcinoma in\-situ of the cervix, carcinoma of the skin or other cancers without evidence of disease at least from 5 years. • HBsAg and HCV positivity. • HIV infection, previous organ transplantation or other clinically evident form of immunodeficiency. • Concurrent treatment with other experimental drugs. • Concurrent Pregnancy or lactation. • Patients not agreeing to take adequate contraceptive measures during the study. • 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).atient\-signed informed consent obtained before registration.