DRKS00003763
Completed
Phase 2
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 - Freiburger IELSG PCNSL-Studie
niversitätsklinikum Freiburg, Abt. Med 1, Hämatologie/ Onkologie0 sites227 target enrollmentMay 8, 2012
ConditionsCentral Nervous System Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Central Nervous System Lymphoma
- Sponsor
- niversitätsklinikum Freiburg, Abt. Med 1, Hämatologie/ Onkologie
- Enrollment
- 227
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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