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New drug combo shows promise against rare brain cancer

NCT ID NCT06115824

Disease control Sponsor: Huashan Hospital 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed study looked at 136 people with newly-diagnosed primary central nervous system lymphoma (a rare brain cancer). Researchers compared standard chemo alone versus chemo plus the targeted drug orelabrutinib. The goal was to see if the combination improved tumor shrinkage and delayed cancer growth. Results are being analyzed to determine if adding orelabrutinib is more effective.

What this could mean

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

Active substance
Orelabrutinib (a targeted cancer drug taken as a pill)
What this could lead to
If successful, adding orelabrutinib to standard chemo could improve tumor shrinkage and delay cancer progression in people with newly-diagnosed primary CNS lymphoma.
What could go wrong
This is a small, single-center retrospective study, not a randomized trial. Results may not apply broadly, and orelabrutinib may cause side effects like infections or bleeding.

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

136 people

The number who actually took part.

Started

Aug 2023

Finished

Jul 2024

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

PCNSL is a rare and highly aggressive subtype of primary extranodal non-Hodgkin's lymphoma with a distinctive clinical presentation, and more than 95% of the pathological types are diffuse large B-cell lymphomas.The current National Comprehensive Cancer Network (NCCN) guidelines recommend first-line induction therapy with high-dose methotrexate (HD-MTX) in combination with rituximab, but long-term efficacy is still unsatisfactory, with 50% of patients relapsing at around 2 years

Ages

18 to 75 years

Sex

Anyone

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: * Pathologically confirmed primary central nervous system lymphoma * Methotrexate-based chemotherapy ± orelabrutinib regimen as first-line treatment for patients Exclusion Criteria: * Patients receiving ≤2 cycles of treatment without efficacy evaluation * Those with uncontrolled or significant cardiovascular disease, including: uncontrolled diabetes mellitus, severe cardiac, pulmonary, hepatic, renal insufficiency) and haematological, endocrine system lesions, history of other uncontrollable malignancies

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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.

Primary central nervous system lymphoma

Contacts and locations

Locations

  • Department of Hematology, Huashan Hospital, Fudan University

    Shanghai, China

More trials for these conditions

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