Primary CNS Lymphoma Clinical Trial
Official title:
Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma
This study was conducted to evaluate the 2-year progression free survival rate of elderly patients with primary CNS lymphoma followed by combination of rituximab and methotrexate followed by rituximab and cytarabine.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically proven diagnosis of B-cell non-Hodgkin's lymphoma, exclusively localized in the central nervous system, cranial nerves, and/or eyes 2. No previous treatment; A tumorectomy on diagnostic purpose and/or use of glucocorticoids is allowed 3. Measurable lesion(s) 4. Age = 60 years 5. Unfit patients for high-dose chemotherapy followed by autologous stem cell transplantation 6. 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 7. 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. 8. Written informed consent 9. ECOG performance scale 0, 1 or 2 10. Life expectancy > 3 months Exclusion Criteria: 1. T-cell or NK/T cell lymphoma 2. 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 3. Young and fit patients who are suitable for high-dose chemotherapy followed by autologous stem cell transplantation 4. Prior radiation therapy on target CNS lesion(s) 5. 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 6. 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 7. Known hypersensitivity to the investigational agent(s) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul | Gangnam-gu, |
Lead Sponsor | Collaborator |
---|---|
Won Seog Kim | Celltrion |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year progression free survival rate | From the end of the last patient's trial, the disease progression will be tracked for up to 2 years, and primary analysis and reporting will be conducted. | the time between the date of treatment start and the date of death due to any cause or date of disease, assessed up to 24 months | |
Secondary | progression free survival | Means the period from the date of consent to the date of disease progression, the time of death, or the last time the disease has not progressed or has confirmed its survival. | 2 years from the date of consent to the date of Progress disease f / u. | |
Secondary | overall survival | It measures the time from start of treatment to death. | Time between the start of treatment and the date of death.assessed up to 5 years] | |
Secondary | Frequency of Adverse events classified by each criterion by CTCAE v4.0 | CTCAE v4 (Common Terminology Criteria for Adverse Events v4.0) In the present study, toxicities will be recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Event (CTCAE), version 4.0. Then, the collected Toxicity is classified by CTCAE term and calculated as%, and a lot of AE will be detected. | from the date of informed consent signature to 31 days after last drug administration. | |
Secondary | time to treatment failure | Means the period from the date of consent to the date of the onset of the disease or to the discontinuation of treatment for any reason. | Within 3 years |
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