[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Won Seog Kim
• Collaborator: Celltrion
• Treatments: Cytarabine; Methotrexate; Rituximab

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)