---
title: Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
nct_id: NCT01011920
overall_status: COMPLETED
phase: PHASE2
sponsor: International Extranodal Lymphoma Study Group (IELSG)
study_type: INTERVENTIONAL
primary_condition: Central Nervous System Lymphoma
countries: Denmark, Germany, Italy, Switzerland, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01011920.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01011920"
ct_last_update_post_date: 2026-03-19
last_seen_at: "2026-05-12T06:10:00.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

**Official Title:** 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

**NCT ID:** [NCT01011920](https://clinicaltrials.gov/study/NCT01011920)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 227
- **Lead Sponsor:** International Extranodal Lymphoma Study Group (IELSG)
- **Conditions:** Central Nervous System Lymphoma
- **Start Date:** 2009-11
- **Completion Date:** 2024-12-19
- **CT.gov Last Update:** 2026-03-19

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **MTX + AraC** (EXPERIMENTAL) — Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
- **MTX + Ara-C + Rituximab** (EXPERIMENTAL) — Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3
- **MTX + Ara-C + rituximab+thiotepa** (EXPERIMENTAL) — Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4
- **WBRT 36 Gy +/- boost 9 Gy** (EXPERIMENTAL) — ARM D: WBRT with 36 Gy in the case of CR to primary chemotherapy or the same WBRT dose followed by a tumor-bed boost of 9 Gy with 1-2 cm of margin surrounding enhanced residual lesion (total tumor-bed dose 45 Gy) in patients who achieved a PR or SD after primary chemotherapy. Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions.
- **BCNU + Thiotepa + APBSCT** (EXPERIMENTAL) — Arm E BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6 Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4 Reinfusion of PBSC ≥5 x 106 CD34+ cells/kg day 0

## Interventions

- **Methotrexate** (DRUG) — Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses.
- **Ara-C** (DRUG) — Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
- **Rituximab** (DRUG) — Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
- **Thiotepa** (DRUG) — ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
- **radiotherapy** (RADIATION) — Photons of 4-10 Mev, 180 cGy per day, 5 weekly fractions. Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the orbits, which must be shielded after 30 Gy (after 36 Gy in the case of evident intraocular disease at diagnosis). Tumor-bed (boost or partial-brain RT) will be irradiated by 2 to 4 isocentric treatment fields based on tumor location, with all portals treated per each RT session.
- **BCNU** (DRUG) — BCNU 400 mg/m2 in 500 ml saline sol 1-hr inf. day -6
- **APBSCT** (OTHER) — Autologous peripheral blood stem cell transplant (APBSCT)

## Primary Outcomes

- **Complete Remission Rate After Primary Chemotherapy** _(time frame: 3 months after treatment start)_ — Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
- **2 Years Failure Free Survival (FFS) After Second Randomization** _(time frame: Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry)_ — Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.

## Secondary Outcomes

- **2 Years Failure Free Survival (FFS)** _(time frame: Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry)_
- **2 Year Overall Survival (OS)** _(time frame: From study entry until 2 years after)_

## Locations (54)

- University Hospital, Aarhus, Denmark
- Rigshospitalet,, Copenhagen, Denmark
- Herlev Hospital, Herlev, Denmark
- University Hospital, Aachen, Germany
- Städtisches Klinikum, Braunschweig, Germany
- Klinikum Bremen-Mitte, Bremen, Germany
- Klinikum Chemnitz, Chemnitz, Germany
- Universitätsklinikum, Cologne, Germany
- Universitätsklinikum Erlangen, Erlangen, Germany
- "Klinik für Hämatologie Universitätsklinikum Essen", Essen, Germany
- Klinikum der Johann-Wolfgang- Goethe-Universität, Frankfurt am Main, Germany
- Uniklinik Freiburg, Freiburg im Breisgau, Germany
- Klinikum der Justus-Liebig-Universität, Giessen, Germany
- Georg-August-Universität, Göttingen, Germany
- Universitätsklinikum Halle, Halle, Germany
- Universitätskrankenhaus Hamburg-Eppendorf, Hamburg, Germany
- SLK-Kliniken GmbH, Heilbronn, Germany
- Universitätsklinikum des Saarlandes, Homburg/Saar, Germany
- Friedrich Schiller Universitaet Jena, Jena, Germany
- Universitätsklinikum und Städtisches Krankenhaus, Kiel, Germany
- Johannes Gutenberg Universität Mainz, Mainz, Germany
- Technische Universität in München, München, Germany
- Universitätsklinikum Ulm, Ulm, Germany
- A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy
- Istituto Tumori Giovanni Paolo II, Bari, Italy
- Ospedale Centrale di Bolzano, Bolzano, Italy
- Spedali Civili, Brescia, Italy
- Ospedale Businco, Cagliari, Italy
- San Raffaele H Scientific Institute, Milan, Italy
- Grande Ospedale Metropolitano Niguarda, Milan, Italy
- Istituto Nazionale Tumori, Fondazione G. Pascale, Naples, Italy
- Ospedale Umberto I, Nocera Inferiore, Italy
- Ospedale Civile S.Spirito, Pescara, Italy
- AOU Pisana, Pisa, Italy
- Ospedale delle Croci, Ravenna, Italy
- Arcispedale Santa Maria Nuova, Reggio Emilia, Italy
- Ospedale degli Infermi, Rimini, Italy
- Istituto Nazionale dei Tumori Regina Elena, Roma, Italy
- Università degli Studi La Sapienza, Roma, Italy
- Humanitas, Rozzano, Italy
- Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
- Azienda Ospedaliera Universitaria Senese, Siena, Italy
- Azienda Ospedaliera Sanitaria Santa Maria, Terni, Italy
- Ospedale Maggiore S. Giovanni Battista, Torino, Italy
- Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy
- Policlinico G.B. Rossi, Verona, Italy
- ULSS 8 Berica - Ospedale S. Bortolo, Vicenza, Italy
- IOSI - Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
- University Hospital Aintree, Liverpool, United Kingdom
- University College Hospital, London, United Kingdom
- The Christie Hospital NHS Foundation Trust, Manchester, United Kingdom
- Nottingham City Hospital, Nottingham, United Kingdom
- Queen's Hospital, Romford, United Kingdom
- Medical Oncology Unit General Hospital, Southampton, United Kingdom

## Recent Field Changes (last 30 days)

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---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01011920.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01011920*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*