Evaluating a new treatment for primary central nervous system lymphoma

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)

This study is testing a new combination treatment for people with untreated primary central nervous system lymphoma to see if it is safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ono Pharmaceutical Co. Ltd (Industry-sponsored)
• Locations: 44 sites (Nagoya-shi, Aichi and 43 other locations)
• Trial ID: NCT06541665 on ClinicalTrials.gov

What this trial studies

This study aims to assess the tolerability and safety of a combination therapy involving ONO-4059 and R-MPV in patients with untreated primary central nervous system lymphoma (PCNSL). It will involve administering ONO-4059 alongside established treatments such as Rituximab, Methotrexate, Procarbazine, and Vincristine. The study will monitor patients for safety and pharmacokinetics to determine the efficacy of this combined approach.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with untreated primary central nervous system lymphoma and with an ECOG Performance Status of 0-2.

Not a fit: Patients with intraocular PCNSL without brain lesions or those unable to swallow oral medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with PCNSL, potentially improving outcomes.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches in treating PCNSL have shown promise in other studies.

Eligibility criteria

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

Where this trial is running

Nagoya-shi, Aichi and 43 other locations

• Aichi Cancer Center — Nagoya-shi, Aichi, Japan (Recruiting)
• Nagoya City University Hospital — Nagoya-shi, Aichi, Japan (Recruiting)
• Akita University Hospital — Akita-shi, Akita, Japan (Recruiting)
• Juntendo University Urayasu Hospital — Urayasu-shi, Chiba, Japan (Not_yet_recruiting)
• Fukuoka University Hospital — Fukuoka-shi, Fukuoka, Japan (Not_yet_recruiting)
• Kyushu University Hospital — Fukuoka-shi, Fukuoka, Japan (Recruiting)
• Hospital of the University of Occupational and Environmental Health,Japan — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
• Kurume University Hospital — Kurume-shi, Fukuoka, Japan (Not_yet_recruiting)
• Fukushima Medical University Hospital — Fukushima-shi, Fukushima, Japan (Recruiting)
• Gifu University Hospital (Tokai National Higher Education and Research System) — Gifu-shi, Gifu, Japan (Not_yet_recruiting)
• Gunma University Hospital — Maebashi-shi, Gunma, Japan (Not_yet_recruiting)
• Sapporo Medical University Hospital — Sapporo-shi, Hokkaido, Japan (Not_yet_recruiting)
• Kobe City Medical Center General Hospital — Kobe-shi, Hyogo, Japan (Recruiting)
• Hyogo Medical University Hospital — Nishinomiya-shi, Hyogo, Japan (Not_yet_recruiting)
• University of Tsukuba Hospital — Tsukuba-shi, Ibaraki, Japan (Recruiting)
• Kanazawa Medical University Hospital — Kahoku-gun, Ishikawa, Japan (Recruiting)
• Kagawa University Hospital — Kita-gun, Kagawa, Japan (Recruiting)
• St. Marianna University Hospital — Kawasaki-shi, Kanagawa, Japan (Not_yet_recruiting)
• Yokohama City University Hospital — Yokohama-shi, Kanagawa, Japan (Recruiting)
• Kochi Medical School Hospital — Nankoku-shi, Kochi, Japan (Recruiting)
• University of Miyazaki Hospital — Miyazaki-shi, Miyazaki, Japan (Not_yet_recruiting)
• NAGASAKI University Hospital — Nagasaki-shi, Nagasaki, Japan (Recruiting)
• Kindai University Nara Hospital — Ikoma-shi, Nara, Japan (Not_yet_recruiting)
• Nara Medical University — Kashihara-shi, Nara, Japan (Not_yet_recruiting)
• Niigata University Medical & Dental Hospital — Niigata-shi, Niigata, Japan (Recruiting)
• Oita University Hospital — Yufu-shi, Oita, Japan (Not_yet_recruiting)
• Kurashiki Central Hospital — Kurashiki-shi, Okayama, Japan (Not_yet_recruiting)
• Osaka International Cancer Institute — Osaka-shi, Osaka, Japan (Not_yet_recruiting)
• Kindai University Hospital — Osakasayama-shi, Osaka, Japan (Not_yet_recruiting)
• Osaka University Hospital — Suita-shi, Osaka, Japan (Not_yet_recruiting)
• Saga University Hospital — Saga-shi, Saga, Japan (Not_yet_recruiting)
• Saitama Medical Center — Kawagoe-shi, Saitama, Japan (Recruiting)
• Shizuoka Cancer Center — Sunto-gun, Shizuoka, Japan (Recruiting)
• Dokkyo Medical University Hospital — Shimotsuga-gun, Tochigi, Japan (Recruiting)
• Institute of Science Tokyo Hospital — Bunkyo-ku, Tokyo, Japan (Recruiting)
• The Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan (Recruiting)
• National Hospital Organization Disaster Medical Center — Midori-cho, Tokyo, Japan (Not_yet_recruiting)
• The Jikei University Hospital — Minato-ku, Tokyo, Japan (Recruiting)
• Toranomon Hospital — Minato-ku, Tokyo, Japan (Recruiting)
• Tokyo Medical University Hospital — Shinjuku-ku, Tokyo, Japan (Recruiting)
• Tokyo Women's Medical University Hospital — Shinjuku-ku, Tokyo, Japan (Not_yet_recruiting)
• Toyama University Hospital — Toyama-shi, Toyama, Japan (Not_yet_recruiting)
• Yamaguchi University Hospital — Ube-shi, Yamaguchi, Japan (Recruiting)
• University of Yamanashi Hospital — Chuo-shi, Yamanashi, Japan (Recruiting)

Study contacts

• Study coordinator: Ono Pharmaceutical Co., Ltd.

Conditions Primary Central Nervous System Lymphoma