CompletedPhase 2

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

Denmark, Germany, Italy227 participantsStarted 2009-11

Plain-language summary

This is a multicenter open label randomized phase II trial. Enrolled Primary Central Nervous System Lymphoma (PCNSL) patients will be stratified according to the IELSG score and randomized to receive one of the follows as primary chemotherapy: * Arm A: Methotrexate (MTX) + Cytarabine (Ara-C) * Arm B: MTX + Ara-C + rituximab * Arm C: MTX + Ara-C + rituximab + thiotepa. Chemotherapy will be administered every three weeks. The maximum number of chemotherapy induction courses will be 4. Patients in Stable Disease (SD) or better after two courses will receive two more courses of the same primary chemotherapy regimen. Stem-cells harvest will be performed in the three arms after the second course. After 4 courses response assessment will be performed. Patients who will not achieve SD or better after the 4th course, as well as those who will experience Progressive Disease (PD) at any time and those who will not achieve a sufficient stem cell harvest, will receive Whole Brain Radiation Therapy (WBRT) 36-40 Gy +/- tumor bed boost of 9 Gy. Patients who will achieve SD or better after the 4th course will be stratified according to objective response to primary chemotherapy and to primary chemotherapy regimen and randomly allocated to receive as consolidation therapy one of the follows: * Arm D: WBRT 36 Gy +/- boost 9 Gy * Arm E: Carmustine (BCNU) + Thiotepa + Autologous Peripheral Blood Stem Cell Transplant (APBSCT) Patients in Complete Response (CR) after WBRT or APBSCT will remain in follow-up. Patients who will not achieve a CR after WBRT will be managed according to physician's preferences. Patients who will not achieve a CR after APBSCT will be referred to WBRT.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma. * Diagnostic sample obtained by stereotactic or surgical biopsy, Cerebrospinal Fluid (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, renal, cardiac, and hepatic function. * 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. Exclusion Criteria: * 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. *…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Remission Rate After Primary Chemotherapy

Timeframe: 3 months after treatment start

2 Years Failure Free Survival (FFS) After Second Randomization

Timeframe: Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry

Trial details

NCT IDNCT01011920

SponsorInternational Extranodal Lymphoma Study Group (IELSG)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2026-02-11

View on ClinicalTrials.gov More Central Nervous System Lymphoma trials