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
- Conditions
- ewly diagnosed Primary CNS Lymphoma
- Registration Number
- EUCTR2009-012432-32-GB
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 126
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method