Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Debbie Hamid


Contact details

Clinical Trials Unit
MP 131
Tremona Road
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

2009-012432-32 number


Protocol/serial number


Study information

Scientific 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.



Study hypothesis

To establish in a prospective, randomized phase II trial, the activity of three different chemotherapy combinations in patients with newly diagnosed primary central nervous system lymphoma (PCNSL):
1. High-dose methotrexate (HD-MTX) + high-dose cytarabine (HD-araC)
2. HD-MTX + HD-araC + rituximab
3. HD-MTX + HD-araC + rituximab + thiotepa

To establish the efficacy of two consolidation strategies: conventional whole-brain radiotherapy (WBRT) vs. highdose chemotherapy supported by autologous stem cell transplantation (HDC + ASCT) in patients with newly diagnosed PCNSL.

Ethics approval

29/06/2011, ref: 11/LO/0420

Study design

Randomised, interventional

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Lymphoma (non-Hodgkin's)


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

Those who are in SD or respond to treatment will be further randomised to consolidation therapy.
Arm D – Whole Brain Radiotherapy
Arm E – BCNU, Thiotepa and Stem Cell Transplant

Follow Up Length: 120 month(s); Study Entry : Multiple Randomisations

Intervention type



Phase II

Drug names

1. Carmustine
2. Cytarabine
3. Methotrexate
4. Rituximab
5. Thiotepa

Primary outcome measure

Complete remission following primary chemotherapy

Secondary outcome measures

Failure-free survival at 2 years

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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 үGT ≤ 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

Participant type


Age group




Target number of participants

Planned Sample Size: 126;

Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment

Germany, Italy, Switzerland, United Kingdom

Trial participating centre

Clinical Trials Unit
SO16 6YD
United Kingdom

Sponsor information


Southampton University Hospitals NHS Trust

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research UK Clinical Trials Advisory and Awards Committee

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2016 results in: (added 10/04/2019)
2. 2017 results in: (added 10/04/2019)

Publication citations

Additional files

Editorial Notes

10/04/2019: Publication reference added. 15/03/2017: No publications found in PubMed, verifying study status with principal investigator