Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
NCT ID: NCT06541665
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-05-17
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL
ONO-4059
Specified dose, once daily
Rituximab
Specified dose on specified days
Methotrexate
Specified dose on specified days
Procarbazine
Specified dose on specified days
Vincristine
Specified dose on specified days
Interventions
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ONO-4059
Specified dose, once daily
Rituximab
Specified dose on specified days
Methotrexate
Specified dose on specified days
Procarbazine
Specified dose on specified days
Vincristine
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 are unable to swallow oral medications
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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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
Countries
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Other Identifiers
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jRCT2071230124
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-4059-13
Identifier Type: -
Identifier Source: org_study_id
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