Clinical trial · Interventional
[CREMA]Combination of R-M Followed by R-A in Elderly Patients With Primary CNS Lymphoma
Combination of Rituximab and Methotrexate Followed by Rituximab and Cytarabine in Elderly Patients With Primary CNS Lymphoma
NCT03569995CI-TRIAL-00047824unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary CNS Lymphoma | Primary Central Nervous System Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine Injection | Drug | Cytarabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction+Consolidation chemotherapy
- description
- \[Induction phase\] 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
- interventionNames
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Cytarabine Injection
Primary outcomes (1)
- measure
- 2-year progression free survival rate
- timeFrame
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.