Primary Central Nervous System LymphomaPhase 1NCT06541665
Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
A Phase 1 study testing ONO-4059, Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 44 sites in Japan.
Trial summary
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma
- What is being tested?
- ONO-4059, Rituximab and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 44 sitesJapan
- Study dates
- 17 May 2024to 31 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with intraocular PCNSL without brain lesions
- Patients are unable to swallow oral medications
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Japan44 sites
Akita University Hospital
Akita, Akita
Institute of Science Tokyo Hospital
Bunkyo-ku, Tokyo
University of Yamanashi Hospital
Chuo-shi, Yamanashi
Fukuoka University Hospital
Fukuoka, Fukuoka
Kyushu University Hospital
Fukuoka, Fukuoka
Fukushima Medical University Hospital
Fukushima, Fukushima
Gifu University Hospital (Tokai National Higher Education and Research System)
Gifu, Gifu
Kindai University Nara Hospital
Ikoma-shi, Nara
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken
Nara Medical University
Kashihara-shi, Nara
Saitama Medical Center
Kawagoe-shi, Saitama
St. Marianna University Hospital
Kawasaki-shi, Kanagawa
Kagawa University Hospital
Kita-gun, Kagawa-ken
Hospital of the University of Occupational and Environmental Health,Japan
Kitakyushu-shi, Fukuoka
Kobe City Medical Center General Hospital
Kobe, Hyōgo
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken
Kurume University Hospital
Kurume-shi, Fukuoka
Gunma University Hospital
Maebashi, Gunma
National Hospital Organization Disaster Medical Center
Midorichō, Tokyo
The Jikei University Hospital
Minato-ku, Tokyo
Toranomon Hospital
Minato-ku, Tokyo
University of Miyazaki Hospital
Miyazaki, Miyazaki
NAGASAKI University Hospital
Nagasaki, Nagasaki
Aichi Cancer Center
Nagoya, Aichi-ken
Nagoya City University Hospital
Nagoya, Aichi-ken
Kochi Medical School Hospital
Nankoku-shi, Kochi
Niigata University Medical & Dental Hospital
Niigata, Niigata
Hyogo Medical University Hospital
Nishinomiya-shi, Hyōgo
Osaka International Cancer Institute
Osaka, Osaka
Kindai University Hospital
Osakasayama-shi, Osaka
Saga University Hospital
Saga, Saga-ken
Sapporo Medical University Hospital
Sapporo, Hokkaido
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo
Osaka University Hospital
Suita-shi, Osaka
Shizuoka Cancer Center
Sunto-gun, Shizuoka
Toyama University Hospital
Toyama, Toyama
University of Tsukuba Hospital
Tsukuba, Ibaraki
Yamaguchi University Hospital
Ube-shi, Yamaguchi
Juntendo University Urayasu Hospital
Urayasu-shi, Chiba
Yokohama City University Hospital
Yokohama, Kanagawa
Oita University Hospital
Yufu-shi, Oita Prefecture
About this study
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)
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
- Conditions
- Primary Central Nervous System Lymphoma
- Being tested
- ONO-4059, Rituximab, Methotrexate, Procarbazine, Vincristine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4059Drug
Also called Tirabrutinib Hydrochloride
Specified dose, once daily
RituximabDrug
Specified dose on specified days
MethotrexateDrug
Specified dose on specified days
ProcarbazineDrug
Specified dose on specified days
VincristineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL | Experimental | Not described Receives: Drug: ONO-4059; Drug: Rituximab; Drug: Methotrexate; Drug: Procarbazine; Drug: Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Secondary outcomes (5)
Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 May 2024
- Primary completion28 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541665
- Sponsor's protocol ID
- ONO-4059-13
- Other IDs
- jRCT2071230124
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06541665
- Acronym / sponsor ID
- ONO-4059-13
- Conditions
- Primary Central Nervous System Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2024 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To confirm the tolerability and safety of combined administration of ONO-4059 and R-MPV therapy in untreated PCNSL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL | Experimental | Drug: ONO-4059, Drug: Rituximab, Drug: Methotrexate, Drug: Procarbazine, Drug: Vincristine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with intraocular PCNSL without brain lesions
- Patients are unable to swallow oral medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4059Also: Tirabrutinib HydrochlorideSpecified dose, once daily | Drug | Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL |
| RituximabSpecified dose on specified days | Drug | Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL |
| MethotrexateSpecified dose on specified days | Drug | Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL |
| ProcarbazineSpecified dose on specified days | Drug | Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL |
| VincristineSpecified dose on specified days | Drug | Tirabrutinib + R-MPV in patients with newly diagnosed, treatment naïve PCNSL |
Primary outcome
Tolerability evaluation
Time frame: 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
Time frame: 2 years
Adverse events at each visit with the NCI CTCAE v5.0 used as a guide for the grading of severity.
5 secondary outcomes
Summary of plasma tirabrutinib concentration at trough and post 2 hours dosing
Time frame: 30days
Duration of response (DOR)
Time frame: 2 years
Time to response (TTR)
Time frame: 1 year
Best overall response (BOR)
Time frame: 1 year
Complete response rate (CRR)
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4059, Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Ono Pharmaceutical Co., Ltd. at 44 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability evaluation (time frame: 29 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.