Clinical trial · Interventional
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With 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
Why stopped (as posted): Study was terminated early due to lack of enrollment.
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| rituximab [MabThera/Rituxan] | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: rituximab [MabThera/Rituxan]
- Drug: Methotrexate
- Drug: Cytarabine
Primary outcomes (2)
- measure
- Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
- timeFrame
- Week 24
- description
- CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, 18-80 years of age; * histological diagnosis of primary central nervous system lymphoma; * B-cell proliferation verified by positive staining for CD20; * \>=1 measurable lesion. Exclusion Criteria: * prior chemotherapy, other than corticosteroids, \>=6 weeks before and after diagnosis or surgery; * history of prior cranial irradiation; * evidence of plurisystemic non-Hodgkin's lymphoma; * other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix; * uncontrolled active infection.
References
Publications (0)
Data not yet available