Clinical Trials in Japan / NCT06541665
Active, not recruiting
Phase 1
Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
NCT06541665 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Primary Central Nervous System Lymphoma
Investigational drug(s) / intervention(s)
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
Study summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients with intraocular PCNSL without brain lesions
* Patients are unable to swallow oral medications
Primary outcome measure(s)
- Tolerability evaluation — 29 Days
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 - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction — 2 years
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.
Trial sites (44)
| Facility | City | Region | Status |
|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | |
| Nagoya City University Hospital | Nagoya | Aichi-ken | |
| Akita University Hospital | Akita | Akita | |
| Juntendo University Urayasu Hospital | Urayasu-shi | Chiba | |
| Fukuoka University Hospital | Fukuoka | Fukuoka | |
| Kyushu University Hospital | Fukuoka | Fukuoka | |
| Hospital of the University of Occupational and Environmental Health,Japan | Kitakyushu-shi | Fukuoka | |
| Kurume University Hospital | Kurume-shi | Fukuoka | |
| Fukushima Medical University Hospital | Fukushima | Fukushima | |
| Gifu University Hospital (Tokai National Higher Education and Research System) | Gifu | Gifu | |
| Gunma University Hospital | Maebashi | Gunma | |
| Sapporo Medical University Hospital | Sapporo | Hokkaido | |
| Kobe City Medical Center General Hospital | Kobe | Hyōgo | |
| Hyogo Medical University Hospital | Nishinomiya-shi | Hyōgo | |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | |
| Kanazawa Medical University Hospital | Kahoku-gun | Ishikawa-ken | |
| Kagawa University Hospital | Kita-gun | Kagawa-ken | |
| St. Marianna University Hospital | Kawasaki-shi | Kanagawa | |
| Yokohama City University Hospital | Yokohama | Kanagawa | |
| Kochi Medical School Hospital | Nankoku-shi | Kochi | |
| University of Miyazaki Hospital | Miyazaki | Miyazaki | |
| NAGASAKI University Hospital | Nagasaki | Nagasaki | |
| Kindai University Nara Hospital | Ikoma-shi | Nara | |
| Nara Medical University | Kashihara-shi | Nara | |
| Niigata University Medical & Dental Hospital | Niigata | Niigata | |
| Oita University Hospital | Yufu-shi | Oita Prefecture | |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken | |
| Osaka International Cancer Institute | Osaka | Osaka | |
| Kindai University Hospital | Osakasayama-shi | Osaka | |
| Osaka University Hospital | Suita-shi | Osaka | |
| Saga University Hospital | Saga | Saga-ken | |
| Saitama Medical Center | Kawagoe-shi | Saitama | |
| Shizuoka Cancer Center | Sunto-gun | Shizuoka | |
| Dokkyo Medical University Hospital | Shimotsuga-gun | Tochigi | |
| Institute of Science Tokyo Hospital | Bunkyo-ku | Tokyo | |
| The Cancer Institute Hospital of JFCR | Koto-ku | Tokyo | |
| National Hospital Organization Disaster Medical Center | Midorichō | Tokyo | |
| The Jikei University Hospital | Minato-ku | Tokyo | |
| Toranomon Hospital | Minato-ku | Tokyo | |
| Tokyo Medical University Hospital | Shinjuku-ku | Tokyo |
+ 4 more sites — see the full list on the official registry below.
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06541665 on ClinicalTrials.gov ↗ ← All trials in Japan