New hope for lymphoma patients who fail standard therapies
NCT ID NCT07525817
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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The First Bethune Hospital of Jilin University
Changchun, Jilin, 130021, China
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