Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
NCT Number: NCT06541665
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Primary Central Nervous System Lymphoma
Interventions: DRUG: ONO-4059|DRUG: Rituximab|DRUG: Methotrexate|DRUG: Procarbazine|DRUG: Vincristine
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-17
Completion Date: 2028-08-31
Locations: Nagoya City University Hospital, Nagoya-shi, Aichi, Japan|Juntendo University Urayasu Hospital, Urayasu-shi, Chiba, Japan|Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan|Hospital of the University of Occupational and Environmental Health,Japan, Kitakyushu-shi, Fukuoka, Japan|Fukushima Medical University Hospital, Fukushima-shi, Fukushima, Japan|Kobe City Medical Center General Hospital, Kobe-shi, Hyogo, Japan|University of Tsukuba Hospital, Tsukuba-shi, Ibaraki, Japan|Kanazawa Medical University Hospital, Kahoku-gun, Ishikawa, Japan|Kagawa University Hospital, Kita-gun, Kagawa, Japan|Yokohama City University Hospital, Yokohama-shi, Kanagawa, Japan|Kochi Medical School Hospital, Nankoku-shi, Kochi, Japan|NAGASAKI University Hospital, Nagasaki-shi, Nagasaki, Japan|Kindai University Nara Hospital, Ikoma-shi, Nara, Japan|Niigata University Medical & Dental Hospital, Niigata-shi, Niigata, Japan|Oita University Hospital, Yufu-shi, Oita, Japan|Osaka University Hospital, Suita-shi, Osaka, Japan|Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan|Dokkyo Medical University Hospital, Shimotsuga-gun, Tochigi, Japan|Tokyo Medical And Dental University, Medical Hospital, Bunkyo-ku, Tokyo, Japan|The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan|The Jikei University Hospital, Minato-ku, Tokyo, Japan|Toranomon Hospital, Minato-ku, Tokyo, Japan|Tokyo Medical University Hospital, Shinjuku-ku, Tokyo, Japan|Tokyo Women's Medical University Hospital, Shinjuku-ku, Tokyo, Japan|Toyama University Hospital, Toyama-shi, Toyama, Japan|Yamaguchi University Hospital, Ube-shi, Yamaguchi, Japan

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

Primary Outcome Measures: Tolerability evaluation, 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, 29 Days|Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction, Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity., 2 years
Secondary Outcome Measures: Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing, 30days|Duration of response (DOR), Duration of response is defined as the time between the date of first response (Complete response (CR), Complete response - unconfirmed (CRu), or partial response (PR) ) and the date of the first progressive disease(PD) according to the IPCG criteria, or date of death due to any cause, whichever occurs first., 2 years|Time to response (TTR), Time to response is defined as the time between the date of first administration of tirabrutinib and the date of first response (CR, CRu, or PR) as determined by IRC according to the IPCG criteria., 1 year|Best overall response (BOR), Best overall response based on independent review committee (IRC) response determination is defined as the best response and is derived programmatically based upon the visit responses determined by IRC from the date of administration of tirabrutinib to the date of PD as determined by IRC or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first., 1 year|Complete response rate (CRR), Complete response rate is defined as the proportion of patients with a best overall response of CR or CRu as determined by an independent review committee according to the IPCG criteria., 4 months