A Phase 3 interventional study of Tirabrutinib and Rituximab in Relapsed/Refractory Primary Central Nervous System Lymphoma, sponsored by Ono Pharmaceutical Co., Ltd.. Recruiting at 42 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
The purpose of this clinical trial is to evaluate efficacy and safety of tirabrutinib alone compared with rituximab and temozolomide (R-TMZ) combination therapy in participants with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL).
Ono Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL:
Exclusion Criteria
Concomitant systemic exposure within 14 days before starting study drug per Investigator assessment with the exception of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tirabrutinib 480 milligram (mg) orally every day (QD), as monotherapy in 28-day cycles.
Drug: Tirabrutinib
Rituximab 375 milligram per square meter (mg/m2) intravenously (IV) and temozolomide 150 mg/m2/day orally, as combination therapy for Cycle 1 through 6 in 28-day cycles.
Drug: Rituximab · Drug: Temozolomide
Administered orally.
Also known as: ONO-4059
Administered intravenously (IV).
Administered orally.
Progression Free Survival (PFS)
PFS based on blinded Independent Review Committee (BIRC) assessment according to International Primary Central Nervous System Lymphoma Collaborative Group (IPCG) criteria, defined as time from randomization to progressive disease (PD) or death due to any cause, whichever occurs first.
Time frame: Estimated up to 24 months
Overall Response Rate (ORR)
ORR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR).
Time frame: Estimated up to 48 months]
Overall Survival (OS)
OS defined as time from randomization until death due to any cause.
Time frame: Estimated up to 48 months
Complete Response Rate (CRR)
CRR based on BIRC per IPCG criteria, defined as the percentage of participants with a best overall response of CR or CRu.
Time frame: Estimated up to 48 months
Best Overall Response (BOR)
BOR based on BIRC per IPCG criteria, defined as the best response from randomization to the date of PD or the date of initiation of subsequent anticancer therapy for PCNSL, whichever occurs first.
Time frame: Estimated up to 48 months]
Time to Response (TTR)
TTR based on BIRC per IPCG criteria, defined as time between randomization and the date of first response of CR, CRu, or PR.
Time frame: Estimated up to 48 months
Time to Complete Response (TTCR)
TTCR based on BIRC per IPCG criteria, defined as the time between randomization and the date of first complete response (CR or CRu).
Time frame: Estimated up to 48 months
Duration of Response (DOR)
DOR based on BIRC per IPCG criteria, defined as the time between the date of first response (CR, CRu, or PR) and the date of the first PD or date of death due to any cause, whichever occurs first.
Time frame: Estimated up to 48 months
Disease Free Survival (DFS)
DFS based on BIRC per IPCG criteria, defined as the time between the date of first complete response (CR or CRu) and the date of the first PD, or date of death due to any cause, whichever occurs first.
Time frame: Estimated up to 48 months
Change from Baseline in Corticosteroid Dose
Time frame: Baseline, estimated up to 48 months
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire Core Module 30 (QLQ-C30) Score
Time frame: Baseline, estimated up to 48 months
Change from Baseline in EORTC Quality of Life Questionnaire Brain Cancer Module (QLQ-BN20) Score
Time frame: Baseline, estimated up to 48 months
Change from Baseline in 5-Level EuroQol 5-Dimensional Questionnaire (EQ-5D-5L) Score
Time frame: Baseline, estimated up to 48 months
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Tirabrutinib
Ono Pharmaceutical Co., Ltd. →