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
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
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
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
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
01/10/2011
Overall trial end date
30/09/2013
Reason abandoned (if study stopped)
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
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
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
Basic results (scientific)
Publication list