Primary Central Nervous System Lymphoma (PCNSL)REVEALNCT06714370
Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study
An observational study of Primary Central Nervous System Lymphoma (PCNSL), run by Ono Pharmaceutical Co., Ltd. at 6 sites in Taiwan.
Trial summary
The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL)
- How many people
- 24 participants
- Where
- 6 sitesTaiwan
- Study dates
- 3 Feb 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients received Taiwan NHI reimbursement
Who may be able to join
- Patient is ≥ 18 years of age.
- r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June 2025.
- Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who lacks the capacity to give informed consent.
- Deceased patients are considered included under an IRB-approved consent waiver.
- Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received.
- Histopathologically confirmed large B-cell PCNSL.
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- Patients with relapsed or refractory PCNSL previously treated at least 2 cycles of HD-MTX.
- Exclude HIV infection
- Exclude Burkitt lymphoma
- Exclude patients using chemotherapy or monoclonal antibodies at the initiation of tirabrutinib treatment.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Chang Gung Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung Univeristy Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital
Taoyuan
About this study
The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.
- Keywords
- REVEAL study, PCNSL, Primary central system lymphoma, Lymphoma, Brain tumor, Rare disease
- Medical subject headings
- Lymphoma, Brain Neoplasms, Rare Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
objective response rate is defined as the proportion of subjects who respond either Complete response (CR), Partial response (PR), or unconfirmed Complete response (CRu) to therapy, according to International PCNSL Collaborative Group (IPCG) criteria.
Measured: At least 9 months for each subject
Secondary outcomes (7)
Duration of response (DOR)
Duration of response is defined as the time from onset of response* to disease progression or death, wichever occurs earlier.
*for patients who achieve complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.
Measured: At least 9 months for each subject
Time-to-treatment response (TTR)
Time-to-treatment response was defined as time from newly started tirabrutinib treatment to the first objective tumor response observed for patients who achieved a complete response (CR), partial response (PR), or unconfirmed complete response (CRu), according to IPCG criteria.
Measured: At least 9 months for each subject
Adverse events of special interest (AESIs)
Drug-related adverse events for treatment interruption, dose reduction, and discontinuation of tirabrutinib: febrile neutropenia (grade≥3), thrombocytopenia with hemorrhage (grade 3), neutropenia (grade 4), thrombocytopenia (grade 4), interstitial lung disease (grade≥2), skin disorder (grade≥2), hematotoxicity (grade≥3, other than events described above) and nonhematological toxicity (other than interstitial lung disease and skin disorder, grade≥3) (the grading will be according to CTCAE v5.0.) important identified risks: infection, severe skin disorder, bone marrow depression, hypersensitivity, interstitial lung disease (ILD), hepatic dysfunction, hemorrhage, arrhythmia.
Measured: At least 9 months for each subject
Clinical laboratory test
Clinical laboratory tests (hematology, blood biochemistry, urinalysis, etc.) will be summarized with dexcriptive statistics. The change from baseline will be presented also, if possible.
Measured: At least 9 months for each subject
Treatment-emergent adverse events (TEAEs)
in this study, an AE is defined as any unfavorable or unintended injury/disease or sign (including an abnormal laboratory finding) in a subject administered tirabrutinib, regardless of causality. AE also includes suspected transmission of infectious agents by tirabrutinib. TEAE is defined as an AE that began after the start of tirabrutinib treatment. Concurrent disease at the start of tirabrutinib treatment that has worsened during tirabrutinib treatment for the subject is also included. worsening of the primary disease is not an TEAE. all severity of AEs will be graded according to CTCAE v5.0. All AE that are not considered serious AE are not-serious AE.
Measured: At least 9 months for each subject
Overall survival (OS)
overall survival is defined as time from newly started tirabrutinib treatment to death.
Measured: At least 9 months for each subject
Progression-free survival (PFS)
Progression-free survival is defined as time from newly started tirabrutinib treatment to either first evidence of progression disease (PD), according to IPCG criteria, or death.
Measured: At least 9 months for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start3 Feb 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
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 Lymphoma (PCNSL)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714370
- Sponsor's protocol ID
- R1128-TIR-04
- Acronym
- REVEAL
- Status last verified
- Apr 2026
- First submitted
- 5 Nov 2024
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence of Effectiveness and Safety of Tirabrutinib in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma in Taiwan: A Nationwide Study
- ClinicalTrials.gov ID
- NCT06714370
- Acronym / sponsor ID
- REVEAL / R1128-TIR-04
- Keywords
- REVEAL study, PCNSL, Primary central system lymphoma, Lymphoma, Brain tumor, Rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Dec 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.
The goal of this observational study is to describe the real-world effectiveness and safety of tirabrutinib among relapsed or refractory PCNSL patients in Taiwan.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received Taiwan NHI reimbursement
Key inclusion criteria (10 listed)
- Patient is ≥ 18 years of age.
- r/r PCNSL patient, who has newly started NHI public reimbursement tirabrutinib from 01 June 2024 to 30 June 2025.
- Have provided voluntary written consent, directly from the subject, or through his/her legal representative for a patient who lacks the capacity to give informed consent.
- Deceased patients are considered included under an IRB-approved consent waiver.
- Note: The NHI reimbursement criteria are listed below for reference purposes only. Subject enrollment depends on whether reimbursement has been received.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective response rate (ORR)
Time frame: At least 9 months for each subject
objective response rate is defined as the proportion of subjects who respond either Complete response (CR), Partial response (PR), or unconfirmed Complete response (CRu) to therapy, according to International PCNSL Collaborative Group (IPCG) criteria.
7 secondary outcomes
Duration of response (DOR)
Time frame: At least 9 months for each subject
Time-to-treatment response (TTR)
Time frame: At least 9 months for each subject
Adverse events of special interest (AESIs)
Time frame: At least 9 months for each subject
Clinical laboratory test
Time frame: At least 9 months for each subject
Treatment-emergent adverse events (TEAEs)
Time frame: At least 9 months for each subject
Overall survival (OS)
Time frame: At least 9 months for each subject
Progression-free survival (PFS)
Time frame: At least 9 months for each subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Central Nervous System Lymphoma (PCNSL), run by Ono Pharmaceutical Co., Ltd. at 6 sites in Taiwan.
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 10 inclusion and 0 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: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective response rate (ORR) (time frame: At least 9 months for each subject). 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 20 May 2026.