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

NCT07525817 | Not Yet Recruiting

• 1 other identifier: 25K492-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mature B-Cell Lymphoma

Keywords

Pirtobrutinib; Covalent BTK inhibitor; Mature B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall Response Rate

  24months

Secondary Outcomes (5)

• BOR

  24 months

• DOR

  24 months

• PFS

  24 months

• OS

  24 months

• Number of participants with treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0

  24 months

Study Arms (1)

Pirtobrutinib Treatment Cohort

Patients with cBTKi-resistant/intolerant mature B-cell lymphoma receiving pirtobrutinib 200 mg once daily in real-world clinical practice.Receive pitobrutinib as monotherapy or in combination, with a recommended dose of 200 mg once daily until disease progression or unacceptable toxicity occurs.

Drug: Pirtobrutinib

Interventions

Pirtobrutinib DRUG

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

Pirtobrutinib Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ou Bai, MD/PHD: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

pirtobrutinib

Central Study Contacts

Ou BAI, MD, PhD

CONTACT

+86-13039046656; oubai16@163.com

Jia Li, MD

CONTACT

+86 13844898514; lijia0810@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)