Chemotherapy with methotrexate and cytarabine with or without thiotepa, and with or without rituximab, followed by brain irradiation vs chemotherapy supported by autologous stem cells transplantation for immunocompetent patients with central nervous system lymphoma

Randomized 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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49014661

Enrollment

126

Registered

2011-08-10

Start date

2011-10-01

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma (non-Hodgkin's) Cancer Non-Hodgkin's lymphoma, unspecified type

Interventions

Patients will be randomised to one of 3 chemotherapy regimens: Arm A ? Methotrexate & Cytarabine Arm B - Methotrexate & Cytarabine with Rituximab Arm C

Study Entry : Multiple Randomisations

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma 2. Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy 3. Disease exclusively localized into the central nervous system, CSF, cranial nerves or eyes 4. At least one measurable lesion 5. Previously untreated patients (previous or ongoing steroid therapy admitted) 6. Aged 18-65 years (with ECOG Performance Status 0-3), Aged 66-70 (with ECOG Performance Status 0-2) 7. Adequate bone marrow (PLT = 100000 mm3, Hb = 9 g/dl, ANC = 2.000 mm3) 8. Adequate bone marrow (PLT =100000 mm3, Hb = 9 g/dl, ANC = 2.000 mm3), renal (creatinine clearance = 60 ml/min) cardiac (VEF = 50%), hepatic function (total serum bilirubin = 3 mg/dL, AST/ALT and ?GT = 2 per upper normal limit value). 9. Sexually active patients of childbearing potential agreeing in implementing adequate contraceptive measures during study participation. (13 is part of 12 inclusion criteria) 10. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 11. Patient-signed informed consent obtained before registration 12. Male or female participants

Exclusion criteria

Exclusion criteria: 1. Patients with lymphomatous lesions outside the CNS 2. Patients with a previous non-Hodgkin lymphoma at any time 3. 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 4. Hepatitis-B-Virus surface antigen (HBsAg) and Hepatitis-C-Virus (HCV) positivity 5. HIV infection, previous organ transplantation or other clinically evident form of immunodeficiency 6.Concurrent treatment with other experimental drugs 7. Concurrent pregnancy or lactation 8. Patients not agreeing to take adequate contraceptive measures during the study 9. 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)

Design outcomes

Primary

Measure	Time frame
Complete remission following primary chemotherapy	—

Secondary

Measure	Time frame
Failure-free survival at 2 years	—

Countries

England, Germany, Italy, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026