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 个研究点目标入组 227 人开始时间: 2012年5月8日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

发起方

niversitätsklinikum Freiburg, Abt. Med 1, Hämatologie/ Onkologie