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. - IELSG 32
- Conditions
- newly diagnosed primary CNS lymphoma in immunocompetent patientsMedDRA version: 9.1Level: LLTClassification code 10036685
- Registration Number
- EUCTR2009-012432-32-IT
- Lead Sponsor
- IELSG-International Extranodal Lymphoma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 126
Histological or cytological assessed diagnosis of non-Hodgkin`s lymphoma. Diagnostic sample obtained by stereotactic or surgical biopsy, 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). HBsAg- and HCV-negative patients. No known HIV disease or immunodeficiency. Adequate bone marrow (PLT ≥ 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 ml/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin ≤ 3 mg/dL, AST/ALT and γGT ≤ 2 per upper normal limit value). Absence of 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) No 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 (patients with a previous lymphoma are NOT eligible). Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. Female patients must be non-pregnant and non-lactating. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation. No concurrent treatment with other experimental drugs. Patient-signed informed consent obtained before registration (Appendix A).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with lymphomatous lesions outside the CNS. 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 Patients with a previous non-Hodgkin lymphoma at any time. 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective at first randomization: to compare in a prospective, randomized phase II trial the activity of primary chemotherapy containing high-dose methotrexate (HD-MTX) + high-dose cytarabine (HD-araC) vs. HD-MTX + HD-araC + rituximab vs. HD-MTX + HD-araC + rituximab + thiotepa, in patients with newly diagnosed PCNSL. Primary objective at second randomization: to compare the efficacy of two consolidation strategies: conventional whole-brain radiotherapy (WBRT) vs. high-dose chemotherapy supported by autologous stem cell transplantation (HDC+ASCT) in patients with newly diagnosed PCNSL.;Secondary Objective: Secondary endpoints: overall survival, meningeal relapse rate, early and late neurotoxicity.;Primary end point(s): The primary endpoint at first randomization is the complete remission (CR) rate after chemotherapy. The primary endpoint at second randomization is the 2-year progression free survival (2-yr PFS).
- Secondary Outcome Measures
Name Time Method