A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma
ConditionMature B-Cell Lymphoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOu Bai, MD/PHD
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Pirtobrutinib
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Ou Bai, MD/PHD
Lead sponsor
The First Hospital of Jilin University
Sponsor institution
Source ClinicalTrials.gov