Clinical trial · Interventional
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
NCT01458730CI-TRIAL-00060097completedPhase 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 the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
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 |
|---|---|---|---|
| Central Nervous System Lymphoma | Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunochemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (2)
- measure
- response rate
- timeFrame
- at completion of therapy
- measure
- neurotoxicity
- timeFrame
- 1-10 years after completion of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment. * Patients treated with steroids alone are eligible * No signs of lymphoma outside the CNS * ECOG performance status 0-4 * Age \> 17 and \< 76 years * Written informed consent from the patient or guardian Exclusion Criteria: * Cardiac failure \> 3 * Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication * Previous malignancy unless disease free for at least five years * Active infection. * Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre. * Positive HIV status * Organ transplantation * Serious psychiatric illness * Prior radiotherapy to the brain * Concomitant anti-inflammatory medication that cannot be discontinued * Creatinine clearance \< 60 ml/minute calculated by Cockcroft and Gault formula * Peripheral blood count with granulocytes \<1.5 x 109L or platelets \< 100 x 109L * Serum bilirubin \>1.5 times or ASAT and alkaline phosphatase \>2 times upper limits of normal. * Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study
References
Publications (1)
- DERIVEDPulczynski EJ, Kuittinen O, Erlanson M, Hagberg H, Fossa A, Eriksson M, Nordstrom M, Ostenstad B, Fluge O, Leppa S, Fiirgaard B, Bersvendsen H, Fagerli UM. Successful change of treatment strategy in elderly patients with primary central nervous system lymphoma by de-escalating induction and introducing temozolomide maintenance: results from a phase II study by the Nordic Lymphoma Group. Haematologica. 2015 Apr;100(4):534-40. doi: 10.3324/haematol.2014.108472. Epub 2014 Dec 5. PMID 25480497