Clinical trial · Interventional
Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
A Multicenter, Phase I, Open-label, Uncontrolled Study of ONO-4059 in Combination With Rituximab, Methotrexate, Procarbazine, and Vincristine (R-MPV) Therapy for Untreated Primary Central Nervous System Lymphoma (PCNSL)
NCT06541665CI-TRIAL-00090487active not recruitingPhase 1ClinicalTrials.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)
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
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 Central Nervous System Lymphoma | Primary Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methotrexate | Drug | Methotrexate | ALIAS |
| ONO-4059 | Drug | — | UNRESOLVED |
| Procarbazine | Drug | Procarbazine | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
- interventionNames
- Drug: ONO-4059
- Drug: Rituximab
- Drug: Methotrexate
- Drug: Procarbazine
- Drug: Vincristine
Primary outcomes (2)
- measure
- Tolerability evaluation
- timeFrame
- 29 Days
- description
- The number of subjects who experienced adverse events and side effects will be tallied. In the tolerability evaluation part, the number of subjects who experienced Dose Limiting Toxicity(DLT) will be tallied
- measure
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with PCNSL * Patients who have not received treatment for PCNSL in the past * Patients with ECOG Performance Status 0-2 * Patients expected to survive for 6 months or more Exclusion Criteria: * Patients with intraocular PCNSL without brain lesions * Patients are unable to swallow oral medications
References
Publications (0)
Data not yet available
No reference posted for this study.