Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Primary Central Nervous System Lymphoma

Treatments: Drug: Vincristine; Drug: ONO-4059; Drug: Procarbazine; Drug: Methotrexate; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06541665

ONO-4059-13

jRCT2071230124 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL

Experimental group

Treatment:

Drug: Rituximab

Drug: Methotrexate

Drug: Procarbazine

Drug: ONO-4059

Drug: Vincristine