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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2071230124 | Registry Identifier | Japan Registry of Clinical Trials |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4059 | Drug | Specified dose, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | Japan | |||
| Nagoya City University Hospital |
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| Rituximab | Drug | Specified dose on specified days |
|
| Methotrexate | Drug | Specified dose on specified days |
|
| Procarbazine | Drug | Specified dose on specified days |
|
| Vincristine | Drug | Specified dose on specified days |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| C000608238 | tirabrutinib |
| D000069283 | Rituximab |
| D008727 | Methotrexate |
| D011344 | Procarbazine |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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