Clinical trial · Interventional
Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma
NCT03688451CI-TRIAL-00065116active not recruitingPhase 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 research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.
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 |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intrathecal rituximab
- description
- Cohort 1: 10 mg dose, day 1 chemotherapy cycles 2-5 Cohort 2: 20 mg dose, day 1 chemotherapy cycles 2-5
- interventionNames
- Drug: Rituximab
Primary outcomes (2)
- measure
- Ability to deliver greater than 80% of planned doses
- timeFrame
- 28 months
- description
- Percentage of planned doses administered for planned accrual
- measure
- Related Grade 3 or higher non-hematological toxicity
- timeFrame
- 28 months
- description
- Number of related grade 3 or higher non-hematological toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy. Exclusion Criteria: * Primary central nervous system lymphoma or established secondary central nervous system disease. * History of spinal surgery and/or ineligible for intrathecal injections.
References
Publications (0)
Data not yet available
No reference posted for this study.