Active — Not RecruitingPhase 1

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

Japan20 participantsStarted 2024-05-17

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tolerability evaluation

Timeframe: 29 Days

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction

Timeframe: 2 years

Trial details

NCT IDNCT06541665

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04-28

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