Clinical trial · Interventional
Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
Randomized Phase II Trial on Primary Chemotherapy With High-dose Methotrexate, Alone or Associated With High-dose Cytarabine, Followed by Response- and Age-tailored Radiotherapy for Immunocompetent Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
- 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)
Aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma
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 |
|---|---|---|---|
| Lymphoma, B Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| high dose cytarabine | Drug | Cytarabine | ALIAS |
| high dose methotrexate | Drug | Methotrexate | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High-dose methotrexate alone
- interventionNames
- Drug: high dose methotrexate
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- High-dose methotrexate associated with high dose cytarabine
- interventionNames
- Drug: high dose methotrexate
- Drug: high dose cytarabine
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- The main endpoint is the complete remission (CR) rate after chemotherapy
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological or cytological diagnosis of non-Hodgkin's lymphoma. 2. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy. 3. Disease exclusively localized into the central nervous system, cranial nerves or eyes. 4. Untreated patients (patients treated with steroids alone are eligible). 5. At least one measurable lesion. 6. Age 18 - 75 years. 7. ECOG performance status \< 3 8. HBsAg-negative and Ab anti-HCV-negative serologic status. 9. No known HIV disease or immunodeficiency. 10. Adequate bone marrow (PLT \> 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin \< 3 mg/dL, AST/ALT and gGT \< 2 per upper normal limit value). 11. No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded). 12. Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 13. Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential. 14. No concurrent treatment with other experimental drugs. 15. Informed consent signed by the patient before registration
References
Publications (1)
- DERIVEDFerreri AJ, Reni M, Foppoli M, Martelli M, Pangalis GA, Frezzato M, Cabras MG, Fabbri A, Corazzelli G, Ilariucci F, Rossi G, Soffietti R, Stelitano C, Vallisa D, Zaja F, Zoppegno L, Aondio GM, Avvisati G, Balzarotti M, Brandes AA, Fajardo J, Gomez H, Guarini A, Pinotti G, Rigacci L, Uhlmann C, Picozzi P, Vezzulli P, Ponzoni M, Zucca E, Caligaris-Cappio F, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). High-dose cytarabine plus high-dose methotrexate versus high-dose methotrexate alone in patients with primary CNS lymphoma: a randomised phase 2 trial. Lancet. 2009 Oct 31;374(9700):1512-20. doi: 10.1016/S0140-6736(09)61416-1. Epub 2009 Sep 18. PMID 19767089