Clinical trial · Interventional
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy
NCT00989352CI-TRIAL-00002687PRIMAINunknownPhase 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)
The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\] in patients \> 65 years.
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 Non Hodgkin Lymphoma of the Central Nervous System | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lomustine | Drug | Lomustine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete remission rate
- timeFrame
- 30 days after end of immuno-chemotherapy
Secondary outcomes (4)
- measure
- Duration of response
- timeFrame
- within 5 years
- measure
- Overall survival time
- timeFrame
- within 5 years
- measure
- Neuropsychological state (according to Mini-Mental State and IPCG testing)
- timeFrame
- within 5 years
- measure
- (Serious) adverse events ([S]AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * first diagnosis of PCNSL, histologically confirmed * age \> 65 years * written signed and dated informed consent of the legal representative and - if possible - of the patient Exclusion Criteria: * manifestations of further lymphoma outside the CNS * sero-positive for HIV * severe pulmonary, cardiac, hepatic, renal impairment * uncontrolled infection * neutrophil count \< 1.500/µl, platelet count \< 100.000/µl * pulmonary disease with IVC \< 55%, DLCO \< 40% * cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia * creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min * bilirubin \> 2mg/dl * ascites or pleural effusion (\> 500ml) * known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone * participation in another clinical trial within the last 30 days prior to the begin or parallel to this study * known or current drug or alcohol abuse
References
Publications (2)
- BACKGROUNDIllerhaus G, Marks R, Muller F, Ihorst G, Feuerhake F, Deckert M, Ostertag C, Finke J. High-dose methotrexate combined with procarbazine and CCNU for primary CNS lymphoma in the elderly: results of a prospective pilot and phase II study. Ann Oncol. 2009 Feb;20(2):319-25. doi: 10.1093/annonc/mdn628. Epub 2008 Oct 26. PMID 18953065
- DERIVEDFritsch K, Kasenda B, Schorb E, Hau P, Bloehdorn J, Mohle R, Low S, Binder M, Atta J, Keller U, Wolf HH, Krause SW, Hess G, Naumann R, Sasse S, Hirt C, Lamprecht M, Martens U, Morgner A, Panse J, Frickhofen N, Roth A, Hader C, Deckert M, Fricker H, Ihorst G, Finke J, Illerhaus G. High-dose methotrexate-based immuno-chemotherapy for elderly primary CNS lymphoma patients (PRIMAIN study). Leukemia. 2017 Apr;31(4):846-852. doi: 10.1038/leu.2016.334. Epub 2016 Nov 15. PMID 27843136