Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
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)
2 other identifiers
interventional
20
1 country
44
Brief Summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2024
Longer than P75 for phase_1
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2024
CompletedFirst Submitted
Initial submission to the registry
August 2, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
June 3, 2025
May 1, 2025
4 years
August 2, 2024
June 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing
30days
Duration of response (DOR)
2 years
Time to response (TTR)
1 year
Best overall response (BOR)
1 year
Complete response rate (CRR)
4 months
Study Arms (1)
Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
EXPERIMENTALInterventions
Specified dose, once daily
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with intraocular PCNSL without brain lesions
- Patients are unable to swallow oral medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Akita University Hospital
Akita, Akita, Japan
Juntendo University Urayasu Hospital
Urayasu-shi, Chiba, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gifu University Hospital (Tokai National Higher Education and Research System)
Gifu, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital
Nishinomiya-shi, Hyōgo, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku-shi, Kochi, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
NAGASAKI University Hospital
Nagasaki, Nagasaki, Japan
Kindai University Nara Hospital
Ikoma-shi, Nara, Japan
Nara Medical University
Kashihara-shi, Nara, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Saga University Hospital
Saga, Saga-ken, Japan
Saitama Medical Center
Kawagoe-shi, Saitama, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
National Hospital Organization Disaster Medical Center
Midorichō, 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, Toyama, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2024
First Posted
August 7, 2024
Study Start
May 17, 2024
Primary Completion (Estimated)
April 28, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share