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

JRCT ID: jRCT2071230124

Registered date:14/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary central nervous system lymphoma
• Date of first enrollment: 17/05/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Concomitant administration of ONO-4059 and rituximab, methotrexate, procarbazine and vincristine (R-MPV) therapy

Outcome(s)

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

Secondary Outcome

-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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Terasawa Tetsuji
• Secondary ID(s): NCT06541665