A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma (NCT07525817) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma
China40 participantsStarted 2026-04-01
Plain-language summary
This is a prospective, multicenter, real-world study to evaluate the efficacy and safety of pirtobrutinib in patients with mature B-cell lymphoma who are resistant or intolerant to prior covalent BTK inhibitors. The primary endpoint is overall response rate (ORR). Secondary endpoints include best overall response (BOR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 40 patients will be enrolled across 8 centers in China.
Who can participate
Age range18 Years
SexALL
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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 hepatit…