Clinical trial NCT06541665: Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Primary Central Nervous System Lymphoma
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.


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

Primary outcomes:
measure: Tolerability evaluation
timeFrame: 29 Days
measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during induction
timeFrame: 2 years
Secondary outcomes:
measure: Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing
timeFrame: 30days
measure: Duration of response (DOR)
timeFrame: 2 years
measure: Time to response (TTR)
timeFrame: 1 year
measure: Best overall response (BOR)
timeFrame: 1 year
measure: Complete response rate (CRR)
timeFrame: 4 months
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Akita-shi
country: Japan
facility: Akita University Hospital
state: Akita
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health,Japan
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu University Hospital (Tokai National Higher Education and Research System)
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital
state: Miyazaki
city: Nagasaki-shi
country: Japan
facility: NAGASAKI University Hospital
state: Nagasaki
city: Ikoma-shi
country: Japan
facility: Kindai University Nara Hospital
state: Nara
city: Kashihara-shi
country: Japan
facility: Nara Medical University
state: Nara
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital
state: Niigata
city: Yufu-shi
country: Japan
facility: Oita University Hospital
state: Oita
city: Kurashiki-shi
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Saga-shi
country: Japan
facility: Saga University Hospital
state: Saga
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Institute of Science Tokyo Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Midori-cho
country: Japan
facility: National Hospital Organization Disaster Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
state: Toyama
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital
state: Yamanashi
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: