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
- Conditions
- Central Nervous System Lymphoma
- Registration Number
- DRKS00003763
- Lead Sponsor
- niversitätsklinikum Freiburg, Abt. Med 1, Hämatologie/ Onkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 227
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.
- 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.
- Patients with the following hematological parameters: Hb< 9g/dl, Neutrophils< 2.000/µl, Thrombocytes< 100.000/µl
Creatinine clearance < 60ml/min
Bilirubin > 3mg/dl, AST/ALT and yGT = 2x increased over normal value
- cardial ejection fraction < 50%; 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)
- Concurrent treatment with other experimental drugs.
- Concurrent Pregnancy or lactation.
- Patients not agreeing to take adequate contraceptive measures during the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - response rate after primary chemotherapy and 2 years failure free survival at second randomization; time frame: 3 months, 2 years<br>
- Secondary Outcome Measures
Name Time Method - safety, as acute and long-term toxicity<br>- overall survival<br>