Phase I study evaluating tolerability, safety, pharmacokinetics, and efficacy of combined ONO-4059 and R-MPV therapy for PCNSL

ONO-4059-13: 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)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071230124

Enrollment

Registered

2024-03-14

Start date

2024-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary central nervous system lymphoma

Interventions

Concomitant administration of ONO-4059 and rituximab, methotrexate, procarbazine and vincristine (R-MPV) therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with PCNSL 2. Patients who have not received treatment for PCNSL in the past 3. Patients with ECOG Performance Status 0-2 4. Patients expected to survive for 6 months or more

Exclusion criteria

Exclusion criteria: 1.Patients with intraocular PCNSL without brain lesions 2.Patients are unable to swallow oral medications

Design outcomes

Primary

Measure	Time frame
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.	—

Secondary

Measure	Time frame
-To evaluate the pharmacokinetics of ONO-4059 when ONO-4059 is administered in combination with R-MPV therapy in untreated PCNSL patients. -To investigate the efficacy of ONO-4059 in combination with R-MPV therapy in untreated PCNSL patients.	—

Contacts

Public ContactSupport Desk JP

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-278-120

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026