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New trial tests stronger chemo cocktails and stem cell transplants for brain cancer

NCT ID NCT01011920

Disease control Sponsor: International Extranodal Lymphoma Study Group (IELSG) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested different combinations of high-dose chemotherapy drugs, with or without the targeted drug rituximab, in 227 patients newly diagnosed with primary CNS lymphoma. After initial chemotherapy, patients who responded well were randomly assigned to receive either whole-brain radiation or a stem cell transplant. The goal was to see which approach leads to better remission rates and longer survival without the cancer returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Methotrexate, Cytarabine, Rituximab, Thiotepa, and autologous stem cell transplant
What this could lead to
If successful, this could identify a more effective chemotherapy regimen and clarify whether stem cell transplant or brain radiation is better for controlling CNS lymphoma.
What could go wrong
This is a phase 2 trial with a moderate number of patients, so results may not be definitive. The treatments involve high-dose chemotherapy with significant side effects, and not all patients may respond or tolerate the therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

227 people

The number who actually took part.

Start date

Nov 2009

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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).

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Conditions

The condition(s) this trial relates to.

primary central nervous system lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central nervous system lymphoma

Contacts and locations

Locations

  • "Klinik für Hämatologie Universitätsklinikum Essen"

    Essen, Germany

  • A.O. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Italy

  • AOU Pisana

    Pisa, Italy

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy

  • Azienda Ospedaliera Sanitaria Santa Maria

    Terni, Italy

  • Azienda Ospedaliera Universitaria Senese

    Siena, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Italy

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Italy

  • Friedrich Schiller Universitaet Jena

    Jena, Germany

  • Georg-August-Universität

    Göttingen, Germany

  • Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • Herlev Hospital

    Herlev, Denmark

  • Humanitas

    Rozzano, Italy

  • IOSI - Oncology Institute of Southern Switzerland

    Bellinzona, 6500, Switzerland

  • Istituto Nazionale Tumori, Fondazione G. Pascale

    Naples, Italy

  • Istituto Nazionale dei Tumori Regina Elena

    Roma, Italy

  • Istituto Tumori Giovanni Paolo II

    Bari, Italy

  • Johannes Gutenberg Universität Mainz

    Mainz, Germany

  • Klinikum Bremen-Mitte

    Bremen, Germany

  • Klinikum Chemnitz

    Chemnitz, Germany

  • Klinikum der Johann-Wolfgang- Goethe-Universität

    Frankfurt am Main, Germany

  • Klinikum der Justus-Liebig-Universität

    Giessen, Germany

  • Medical Oncology Unit General Hospital

    Southampton, United Kingdom

  • Nottingham City Hospital

    Nottingham, United Kingdom

  • Ospedale Businco

    Cagliari, Italy

  • Ospedale Centrale di Bolzano

    Bolzano, Italy

  • Ospedale Civile S.Spirito

    Pescara, Italy

  • Ospedale Maggiore S. Giovanni Battista

    Torino, Italy

  • Ospedale Umberto I

    Nocera Inferiore, Italy

  • Ospedale degli Infermi

    Rimini, Italy

  • Ospedale delle Croci

    Ravenna, Italy

  • Policlinico G.B. Rossi

    Verona, Italy

  • Queen's Hospital

    Romford, United Kingdom

  • Rigshospitalet,

    Copenhagen, Denmark

  • SLK-Kliniken GmbH

    Heilbronn, Germany

  • San Raffaele H Scientific Institute

    Milan, Italy

  • Spedali Civili

    Brescia, Italy

  • Städtisches Klinikum

    Braunschweig, Germany

  • Technische Universität in München

    München, Germany

  • The Christie Hospital NHS Foundation Trust

    Manchester, United Kingdom

  • ULSS 8 Berica - Ospedale S. Bortolo

    Vicenza, Italy

  • Uniklinik Freiburg

    Freiburg im Breisgau, Germany

  • University College Hospital

    London, United Kingdom

  • University Hospital

    Aarhus, Denmark

  • University Hospital

    Aachen, Germany

  • University Hospital Aintree

    Liverpool, United Kingdom

  • Università degli Studi La Sapienza

    Roma, Italy

  • Universitätsklinikum

    Cologne, Germany

  • Universitätsklinikum Erlangen

    Erlangen, Germany

  • Universitätsklinikum Halle

    Halle, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, Germany

  • Universitätsklinikum und Städtisches Krankenhaus

    Kiel, Germany

  • Universitätskrankenhaus Hamburg-Eppendorf

    Hamburg, Germany

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Other studies related to the condition(s) this trial covers.