This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pirtobrutinib will be administered orally at a dose of 200 mg once daily for 6 months, beginning on Day 30 after commercial anti-CD19 CAR-T cell infusion. Dose interruption, dose reduction, or treatment discontinuation will be performed according to protocol-specified toxicity management rules.
A second infusion of commercial anti-CD19 CAR-T cells may be administered after completion of 6 months of pirtobrutinib maintenance therapy in selected patients who do not achieve complete response, or who achieve complete response but remain ctDNA-positive, based on investigator assessment and protocol-defined criteria.
Sun yat-sen university cancer center
Guangzhou, Guangdong, China
Complete response rate (CRR)
CRR is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy
Best complete response rate (bCRR)
bCRR is defined as the proportion of patients whose best response is complete response according to the Lugano 2014 criteria.
Time frame: Up to 24 months
Best objective response rate (bORR)
bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.
Time frame: Up to 24 months
Objective response rate (ORR)
ORR is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria at 6 months after initiation of pirtobrutinib maintenance therapy.
Time frame: At 6 months after initiation of pirtobrutinib maintenance therapy
Duration of complete response (DoCR)
DoCR is defined as the time from the first documented complete response to disease progression or death from any cause, whichever occurs first.
Time frame: Up to 24 months
Duration of response (DOR)
DOR is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
Time frame: Up to 24 months
Progression-free survival (PFS)
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PFS is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first.
Time frame: Up to 24 months
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: Up to 24 months
Incidence of adverse events (AEs) and serious adverse events (SAEs)
The incidence and severity of adverse events will be assessed and graded according to the National Cancer In Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time frame: Up to 30 days after the last dose of pirtobrutinib