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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirtobrutinib Maintenance After CAR-T Cell Therapy | Experimental | Patients will receive pirtobrutinib 200 mg orally once daily starting on Day 30 after commercial anti-CD19 CAR-T cell infusion. Pirtobrutinib maintenance therapy will be continued for 6 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur. Patients who do not achieve complete response after 6 months of maintenance therapy, or who achieve complete response with detectable ctDNA, may receive a second infusion of commercial CAR-T cells at the investigator's discretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirtobrutinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months after initiation of pirtobrutinib maintenance therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| Best objective response rate (bORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-sen university cancer center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C000723100 | pirtobrutinib |
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| Second Infusion of Commercial Anti-CD19 CAR-T Cells | Biological | 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. |
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bORR is defined as the proportion of patients whose best response is complete response or partial response according to the Lugano 2014 criteria.
| 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. | 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. | 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. | Up to 24 months |
| Progression-free survival (PFS) | PFS is defined as the time from enrollment to disease progression or death from any cause, whichever occurs first. | Up to 24 months |
| Overall survival (OS) | OS is defined as the time from enrollment to death from any cause. | 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. | Up to 30 days after the last dose of pirtobrutinib |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |