Mar. 14, 2024 |
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Aug. 06, 2024 |
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jRCT2071230124 |
ONO-4059-13: 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) |
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Phase I study evaluating tolerability, safety, pharmacokinetics, and efficacy of combined ONO-4059 and R-MPV therapy for PCNSL |
Osawa Masahiro |
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Ono Pharmaceutical Co.,LTD |
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3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka |
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+81-120-626-190 |
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clinical_trial@ono-pharma.com |
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Medical Information Center |
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Ono Pharmaceutical Co.,LTD |
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3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka |
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+81-120-626-190 |
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clinical_trial@ono-pharma.com |
Recruiting |
April. 05, 2024 |
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May. 17, 2024 | ||
20 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1. Patients diagnosed with PCNSL |
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1.Patients with intraocular PCNSL without brain lesions |
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18age old over | ||
No limit | ||
Both |
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Primary central nervous system lymphoma |
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Concomitant administration of ONO-4059 and rituximab, methotrexate, procarbazine and vincristine (R-MPV) therapy |
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To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients. |
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-To evaluate the pharmacokinetics of ONO-4059 when ONO-4059 is administered in combination with R-MPV therapy in untreated PCNSL patients. |
Ono Pharmaceutical Co.,LTD |
Kyushu University Hospital Institutional Review Board | |
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Fukuoka | |
Approval | |
No |
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none |