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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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pirtobrutinib

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Pirtobrutinib Treatment Cohort1 intervention

Trial outcomes

Primary outcomes

1

ORR

Overall Response Rate

Time frame
24months

Secondary outcomes

1

BOR

Best Overall Response

Time frame
24 months
2

DOR

Duration of Response

Time frame
24 months
3

PFS

Progression-Free Survival

Time frame
24 months
4

OS

Overall Survival

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ou Bai, MD/PHD

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: