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Old drug, new hope? ibrutinib tackles tough brain cancer

NCT ID NCT05782374

Disease control Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study reviews medical records of 36 adults with relapsed or refractory primary central nervous system lymphoma (PCNSL) who were treated with ibrutinib alone or with R-CHOP chemo. The goal is to see how many patients respond to treatment. PCNSL is a rare and aggressive brain lymphoma, and this research aims to find better options for those who have failed initial therapy.

What this could mean

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

Active substance
ibrutinib
What this could lead to
If this works, it could offer a treatment option for people with relapsed PCNSL, a rare and aggressive brain lymphoma.
What could go wrong
This is a small, retrospective study with only 36 participants, so results may not apply to everyone. Ibrutinib can cause side effects like bleeding or infections.

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.

Participants

About 36 people

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

Started

Aug 2022

Expected to finish

Aug 2026

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.

Who is studied

Adult patients diagnosed with relapsed or refractory PCNSL who in the period between August 2020 and May 2022 were candidates for treatment with ibrutinib alone or in combination with R-CHOP or R-CHOP like (in compassionate use, or off- label).

Ages

18 to 80 years

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: * Histological or cytological diagnosis of DLBCL * Disease localized exclusively in the CNS (brain, meninges, cranial nerves, eyes and / or spinal cord) both at first diagnosis and at failure * Progressive or recurrent disease * Previous treatment with high-dose methotrexate-based chemotherapy ± WBRT * Age 18 - 80 years * ECOG performance status 0-3 * Adequate hematopoiesis (platelets\> 25,000 / mm3, hemoglobin\> 8 g / dL, ANC\> 1,000 / mm3), renal (serum creatinine \<2 times UNL and creatinine clearance ≥40 mL / min), cardiac (VEF ≥50% ) and liver function (SGOT / SGPT \<3 times UNL, bilirubin and alkaline phosphatase \<2 times UNL). * Patients who have been given treatment with ibrutinib, alone or in combination with immunochemotherapy, and who have or have not received the same. Exclusion Criteria: * Patients with concomitant extra-CNS disease at presentation or relapse * Symptomatic coronary heart disease, cardiac arrhythmias not well controlled with drugs, or myocardial infarction within the past 6 months (New York Heart Association class III or IV heart disease) * Any other serious medical condition that could compromise the patient's ability to adhere to treatment. * Presence of any psychological, family, sociological or geographical condition that may hinder compliance with the study protocol and the follow-up program. * In therapy with strong CYP3A inhibitors

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Conditions

The condition(s) this trial relates to.

primary central nervous system lymphoma

As listed by the trial registrant

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

PCNSL

Contacts and locations

Locations

  • Ospedale San Raffaele

    Milan, Italy, 20132, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.