Combination therapy for elderly patients with primary CNS lymphoma
Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma
This study is testing a new combination treatment for older patients with primary CNS lymphoma to see if it helps them live longer without their cancer getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, rituximab, methotrexate |
| Locations | 1 site (Seoul, Gangnam-gu,) |
| Trial ID | NCT03569995 on ClinicalTrials.gov |
What this trial studies
This study evaluates the two-year progression-free survival rate in elderly patients diagnosed with primary CNS lymphoma. It involves a combination treatment approach using rituximab and methotrexate followed by rituximab and cytarabine. The study aims to address the lack of high-level evidence for standard therapies in this patient population, particularly focusing on those unfit for high-dose chemotherapy. The methodology includes careful monitoring of organ functions and eligibility criteria to ensure patient safety and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60 and above with a histologically confirmed diagnosis of B-cell non-Hodgkin's lymphoma localized to the central nervous system.
Not a fit: Patients who have previously received treatment for their lymphoma or those with significant comorbidities that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for elderly patients with primary CNS lymphoma.
How similar studies have performed: While studies on primary CNS lymphoma in elderly patients are limited, the proposed combination therapy approach has shown promise in other contexts, though this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Seoul, Gangnam-gu,
- Samsung Medical Center — Seoul, Gangnam-gu,, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Wonseog Kim, M.D — Samsung Medical Center
- Study coordinator: Wonseog Kim, M.D
- Email: wonseog.kim@samsung.com
- Phone: 82-3410-6548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.