Condition category
Cancer
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
11/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Debbie Hamid

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

2009-012432-32

ClinicalTrials.gov number

NCT01011920

Protocol/serial number

10139

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.

Acronym

IELSG32

Study hypothesis

Patients will be randomised to one of three chemotherapy regimens. Those who are in SD or better after this will be randomised to one of two consolidation therapies (whole-brain radiotherapy [WBRT] or carmustine, thiotepa prior to stem cell transplant).

Objectives - 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

The other objective is 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

First MREC, 29 June 2011, ref: 11/LO/0420

Study design

Randomised, interventional

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Lymphoma (non-Hodgkin's)

Intervention

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

Drug

Phase

Phase II

Drug names

Carmustine, cytarabine, methotrexate, rituximab, thiotepa

Primary outcome measures

Complete remission following primary chemotherapy

Secondary outcome measures

Failure-free survival at 2 years

Overall trial start date

01/10/2011

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/10/2011

Recruitment end date

30/09/2013

Locations

Countries of recruitment

Germany, Italy, Switzerland, United Kingdom

Trial participating centre

Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.suht.nhs.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK Clinical Trials Advisory and Awards Committee

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes