Can a daily pill keep brain lymphoma at bay after remission?
NCT ID NCT06940791
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial is testing whether taking tirabrutinib daily can help people with primary central nervous system lymphoma (PCNSL) stay in remission longer after their initial chemotherapy has worked. Participants who have achieved complete remission will be randomly assigned to receive either tirabrutinib or a placebo, and researchers will compare how long it takes for the disease to progress. The goal is to see if this maintenance approach can delay or prevent relapse without the need for whole-brain radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tirabrutinib, an oral drug taken daily, compared against a placebo
- What this could lead to
- If effective, tirabrutinib maintenance could become a standard way to keep primary CNS lymphoma in remission longer, potentially delaying or preventing relapse without the need for whole-brain radiation.
- What could go wrong
- This is a phase II trial with a modest number of participants, so results may not be definitive. Tirabrutinib can cause side effects, and the benefit over placebo is not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histopathological diagnosis of B cell lymphoma. 2. Newly-diagnosed PCNSL confined to the cerebrum, cerebellum and brainstem. Patients with or without interocular lymphoma are eligible. 3. Negative cerebrospinal fluid (CSF) cytology, or no evidence of leptomeningeal lymphomatosis in contrast-enhanced magnetic resonance imaging (MRI) of the brain and the whole spinal cord. 4. No evidence of systemic lymphoma before induction chemotherapy, confirmed by contrast-enhanced CT including the neck, chest, abdomen, pelvic cavity and groin, or whole-body positron-emission tomography (PET) and CT. 5. Patients with a single lesion, or multiple lesions, are eligible. 6. Patients 18 years old or older at the time of registration. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, 2. 8. Have completed either of the following methotrexate (MTX)-based chemotherapy i) R-MPV (rituximab, MTX, procarbazine and vincristine) ii) MPV (MTX, procarbazine and vincristine) iii) R-MP (rituximab, MTX and procarbazine) iv) MP (MTX and procarbazine) v) R-M (rituximab and MTX) vi) MTX monotherapy 9. Complete response (CR) or complete response unconfirmed (CRu) based on the International PCNSL Collaborative Group (IPCG) criteria. 10. Within 60 days from the last dose of induction or consolidation chemotherapy. 11. No treatment history of radiotherapy for PCNSL. 12. Refused to receive consolidation radiotherapy. 13. No treatment history of chemotherapy or radiotherapy, except for stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) for non-cancer diseases (such as arteriovenous malformations). 14. Adequate organ function. i) Neutrophil count \>=1,000/mm3 ii) Hemoglobin \>= 8.0 g/dl iii) Platelet count \>= 75,000/mm3 iv) AST \<=120 U/L v) ALT \<= 120 U/L vi) Total Bilirubin \<= 2.25 mg/dl vii) Creatinine \<= 1.5 mg/dL 15. Written informed consent. Exclusion Criteria: 1. Synchronous or metachronous malignancies. 2. Infections requiring systemic treatment at the time of registration. 3. Body temperature \>=38 degree celsius at the time of registration. 4. Serious lung disorders, such as interstitial pneumonia, obstructive lung disease, hypersensitive pneumonitis, symptomatic bronchospasm) at the time of registration. 5. History or presence of aspergillus pneumonitis or pneumocystis pneumonia. 6. History of serious drug allergy or serious anaphylaxis. 7. Heart failure (\>= III in New York Heart Association functional classification), unstable angina pectoris, or history of myocardial infarction within the preceding 180 days prior to registration. 8. Treated by anticoagulants at the time of registration. 9. Treated by antiplatelets at the time of registration. 10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP). 11. Immune deficiency, such as acquired immunodeficiency syndrome (AIDS), X-linked agammaglobulinemia, chronic granulomatous disease, Wiskott-Aldrich syndrome, or any other iatrogenic immunosuppressive conditions. 12. Post organ transplant immunosuppression. 13. Prednisone use of \>10 mg/day for condition other than intracranial tumor, or regular use of immunosuppressants. 14. Uncontrolled diabetes mellitus. 15. Treated either by CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inducers within 14 days prior to registration. 16. Gadolinium allergy. 17. Positive HIV antibody. 18. Positive HBs antigen. 19. Positive HBs antibody or HBc antibody, and HBV-DNA positive. 20. Positive HCV antibody. 21. Unable to take oral medicine, 22. Females during pregnancy, or within 28 days postpartum, or during lactation. Males who wish childbearing of his partner. 23. Prior history of treatment by BTK inhibitors. 24. Severe psychiatric disorders.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kyorin University Hospital
RECRUITINGTokyo, 181-8611, Japan
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