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New oral drug takes on tough brain cancer in phase 3 trial

NCT ID NCT07104032

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 10 times

Summary

This phase 3 trial is testing whether the oral targeted drug tirabrutinib works better than a standard combination of rituximab and temozolomide for people with relapsed or refractory primary central nervous system lymphoma (PCNSL). About 132 participants will be randomly assigned to receive either tirabrutinib alone or the combination therapy. The main goal is to see how long the cancer stays under control, with secondary goals including overall response and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirabrutinib (a targeted cancer pill)
What this could lead to
If it works, this could offer a more convenient oral treatment option for people with relapsed brain lymphoma, potentially improving survival without the need for combination chemotherapy.
What could go wrong
This is still an early-stage comparison in a rare cancer, so results may not apply broadly. Tirabrutinib may cause side effects like bleeding or infection, and it's not yet proven to be better than the standard combination therapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

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

Started

Jun 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Pathology report confirming the diagnosis of B-cell PCNSL 2. Relapsed or refractory B-cell PCNSL with at least 1 prior high-dose methotrexate (HD-MTX) based therapy for PCNSL: * Relapsed disease: Participants who achieved a response (CR, CRu, PR) to the last treatment and subsequently experienced disease progression. * Refractory disease: Participants whose best response to the last treatment was stable disease or PD. 3. One or more bi-dimensionally measurable brain lesions with a minimum diameter greater than or equal to (≥)1 centimeter (cm) × ≥1 cm in gadolinium-enhanced magnetic resonance imaging (MRI) 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 5. Adequate bone marrow, renal, and hepatic function per central lab values 6. Participants must agree to comply with all defined contraceptive requirements Exclusion Criteria 1. Participants with isolated intraocular PCNSL or spinal PCNSL with no brain lesions 2. Participants with non-B-cell PCNSL 3. Participants with systemic presence of lymphoma 4. Refractory to temozolomide with or without rituximab-containing regimens in the last PCNSL treatment 5. Concomitant systemic corticosteroid exposure within 14 days before starting study drug per Investigator assessment with the exception of the following: * Equivalent of up to 10 milligram per day (mg/day) of prednisone for a disease other than PCNSL * Equivalent of up to 50 mg/day of prednisone (equal to 8 mg/day dexamethasone) for participants with lesions of the brain and/or spinal cord 6. Active malignancy, other than PCNSL requiring systemic therapy 7. Poorly controlled comorbidity, or history of medical conditions contraindicated per Investigator assessment 8. Participants who are unable to swallow oral medication 9. Prior Bruton's tyrosine kinase inhibitor treatment

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Conditions

The condition(s) this trial relates to.

primary central nervous system lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory primary central nervous system lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 6 countries. 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

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Italy, 25123, Italy

  • Atlantic Health Overlook Medical Center

    RECRUITING

    Summit, New Jersey, 07901, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Epworth Healthcare

    RECRUITING

    Melbourne, Victoria, 3002, Australia

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • HonorHealth Cancer Center

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Hospital Center University De Montpellier

    RECRUITING

    Montpellier, France, 34090, France

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Spain, Spain

  • Hospital Universitario 12 De Octubre

    RECRUITING

    Madrid, Spain, 28041, Spain

  • Hôpitaux de Marseille

    RECRUITING

    Marseille, France, 13005, France

  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST

    RECRUITING

    Meldola, Italy, 47014, Italy

  • John Hopkins University

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Cancer Center

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Cancer Center

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Cancer Center

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Penn State Health Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Providence Medical Foundation

    RECRUITING

    Fullerton, California, 92835, United States

  • Providence Neurological Specialties West

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • UC Irvine Health

    RECRUITING

    Orange, California, 92868, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University Hospital Královské Vinohrady

    RECRUITING

    Prague, Czechia, 10034, Czechia

  • University Hospital Ostrava

    RECRUITING

    Ostrava, Czechia, 708 52, Czechia

  • University of Florida Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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