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Can a daily pill keep brain lymphoma at bay after remission?

NCT ID NCT06940791

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Kyorin University Hospital

    RECRUITING

    Tokyo, 181-8611, Japan

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