NCT07525817

A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma

A Prospective, Multicenter, Real-World Study of Pirtobrutinib in Patients With Mature B-Cell Lymphoma Resistant or Intolerant to Covalent Bruton Tyrosine Kinase Inhibitors

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Ou Bai, MD/PHD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, multicenter, observational real-world study enrolls 40 patients with histologically confirmed mature B-cell lymphoma who have failed or are intolerant to at least one covalent BTK inhibitor. Patients receive pirtobrutinib 200 mg once daily until disease progression or unacceptable toxicity. Efficacy is assessed per Lugano 2014, iwCLL 2018, and IWWM-11 criteria. Safety is evaluated using CTCAE v5.0. The primary outcome is ORR. Secondary outcomes include BOR, DOR, PFS, OS, and safety profile.

Conditions

• Mature B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Pirtobrutinib 200 mg administered orally once daily, in accordance with standard clinical practice, until disease progression, unacceptable toxicity, or study completion.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China