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New hope for lymphoma patients who fail standard therapies

NCT ID NCT07525817

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a drug called pirtobrutinib in 40 people with mature B-cell lymphoma whose cancer has worsened or who cannot tolerate other BTK inhibitor drugs. Participants take one pill daily. Researchers will measure how many patients respond, how long the response lasts, and track side effects. The study is not yet recruiting and will take place at 8 centers in China.

What this could mean

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

Active substance
Pirtobrutinib
What this could lead to
If successful, this could provide a new treatment option for patients with B-cell lymphoma who have stopped responding to other BTK inhibitors.
What could go wrong
This is a small, early real-world study with only 40 participants. It may not show strong enough results or could have unexpected side effects.

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 40 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

This study enrolls 40 adult patients (≥18 years old) with histologically confirmed mature B-cell lymphoma who are resistant or intolerant to at least one prior covalent BTK inhibitor (cBTKi) therapy, across 8 clinical centers in China.

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: * Age ≥18 years; * Histopathological confirmation of mature B-cell lymphoma, primarily including CLL/SLL, MCL, FL, MZL, WM/LPL, etc.; * Disease progression and/or intolerance after prior treatment with ≥1 cBTKi (including ibrutinib, ibrutinib, zanubrutinib, or acitinib); * ECOG PS 0-2; * Adequate liver and kidney function: the following criteria must be met simultaneously: 1) AST and ALT ≤ 3×ULN; 2) Total bilirubin ≤ 1.5×ULN; 3) Creatinine clearance rate ≥ 30 mL/min; * Participants must be voluntary and capable of completing the study procedures and follow-up examinations; * Informed consent must be obtained voluntarily prior to screening. Exclusion Criteria: * Patients with known allergic reactions to any component or excipient of piteutinib; * Patients concurrently participating in other clinical studies; * A history of clinically significant, uncontrolled cardiac, * Cardiovascular disease, or myocardial infarction within 6 months prior to planned initiation of piteutinib therapy; * Uncontrolled systemic bacterial, viral, fungal, or parasitic infections; current use of potent CYP3A4 inhibitors or inducers and/or potent P-gp inhibitors; * Positive human immunodeficiency virus (HIV) testing; * Active hepatitis B or C: 1) Patients with positive hepatitis B virus (HBV) DNA testing and controlled disease status may be enrolled with investigator approval. For HBV DNA-positive patients, concurrent antiviral therapy is required. 2) Patients with prior hepatitis C virus (HCV) infection history who have completed antiviral therapy with viral loads below the quantitative limit may be enrolled; * Based on the investigator's assessment, participants may be unable to complete all study protocol requirements, including follow-up visits, and/or adhere to all study procedures; * A history of other clinically significant diseases or comorbidities; and any safety risks or potential interference with study completion as evaluated by investigators.

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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

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021, China

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