[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
Primary CNS Lymphoma
About this trial
This is an interventional treatment trial for Primary CNS Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically proven diagnosis of B-cell non-Hodgkin's lymphoma, exclusively localized in the central nervous system, cranial nerves, and/or eyes
- No previous treatment; A tumorectomy on diagnostic purpose and/or use of glucocorticoids is allowed
- Measurable lesion(s)
- Age ≥ 60 years
- Unfit patients for high-dose chemotherapy followed by autologous stem cell transplantation
Adequate organ functions
- Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
- Platelets ≥ 50 x 109/L
- Hemoglobin ≥ 8.0 g/dL
- Serum Creatinine ≤ 1.5 x upper limit normal (ULN)
- Serum Bilirubin ≤ 1.5 x ULN
- AST and ALT ≤ 3 x ULN
- Patients with adequately controlled HBV, HCV or HIV are allowed. In case of HBV (+), adequate anti-viral prophylaxis should be incorporated. In case of HIV (+), highly active anti-retroviral therapy should be incorporated.
- Written informed consent
- ECOG performance scale 0, 1 or 2
- Life expectancy > 3 months
Exclusion Criteria:
- T-cell or NK/T cell lymphoma
- Any evidence of systemic non-Hodgkin's lymphoma as demonstrated by computed tomography scan of the neck, chest, abdomen, and pelvis and bone marrow examinations
- Young and fit patients who are suitable for high-dose chemotherapy followed by autologous stem cell transplantation
- Prior radiation therapy on target CNS lesion(s)
- Concurrent severe or uncontrolled medical conditions, laboratory abnormalities or psychiatric disorders that would preclude the participants in the study by the discretion of attending physicians
- Metachronous malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin, or CIN of uterine cervix, or prostate cancer that can be observed without treatment
- Known hypersensitivity to the investigational agent(s)
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Induction+Consolidation chemotherapy
[Induction phase] ① After induction therapy (Rituximab-Methotrexate) 2 times, first evaluation Complete, partial response or stable disease-> next step Progressive disease-> eliminated ② After Induction therapy (Rituximab-Methotrexate) was added 3 times (total 5 times), 2nd evaluation Complete response -> consolidation therapy(Rituximab-Cytarabine) progress Partial response or stable disease-> Rituximab-Methotrexate 2 additional administrations Progressive disease-> eliminated ③ After Induction therapy (Rituximab-Methotrexate) was added twice (7 times in total), 3rd evaluation Complete, partial response or stable disease-> consolidation therapy(Rituximab-Cytarabine) Progressive disease-> eliminated