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Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
Sponsor: Ono Pharmaceutical Co. Ltd
Summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-05-17
Completion Date
2028-08-31
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
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
Locations (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