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Mantle cell lymphoma (MCL) is an aggressive yet often indolent type of B-cell non-Hodgkin lymphoma (NHL). Rocbrutinib (LP-168) is a novel, highly selective, fourth-generation Bruton's tyrosine kinase (BTK) inhibitor that exhibits both covalent (irreversible) and non-covalent (reversible) binding. This unique dual mechanism of action has shown promising efficacy and a favorable safety profile across various B-cell NHL subtypes in prior Phase 1 and 2 studies. This is a Phase 3, randomized, open-label study comparing Rocbrutinib versus investigator's choice of BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) in patients with MCL who have received at least one prior line of therapy and are naïve to BTK inhibitor treatment (except for intolerance).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Rocbrutinib) | Experimental |
| |
| Arm B (ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocbrutinib | Drug | Rocbrutinib at 150 mg once daily orally until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by IRC | approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by INV | approximately 30 months | |
| Overall Response Rate (ORR) assessed by IRC and INV, respectively | Up to approximately 24 months | |
| Duration of Response (DOR) assessed by IRC and INV, respectively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song | Contact | +86-010-88196118 | SongYQ_VIP@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Ibrutinib | Drug | Ibrutinib, 560 mg once daily orally and continuously |
|
| Acalabrutinib | Drug | Acalabrutinib, 100 mg twice daily orally and continuously |
|
| Zanubrutinib | Drug | Zanubrutinib, 160 mg twice daily orally and continuously |
|
| Orelabrutinib | Drug | Orelabrutinib, 150 mg once daily orally and continuously |
|
| approximately 30 months |
| Overall Survival | approximately 40 months |
| Number of participants with treatment-emergent adverse event as assessed by CTCAE v5.0 | Up to approximately 40 months |
| Number of participants with treatment-related adverse event as assessed by CTCAE v5.0 | Up to approximately 40 months |
| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | 530021 | China |
|
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| 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 |
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| ID | Term |
|---|---|
| C551803 | ibrutinib |
| C000604908 | acalabrutinib |
| C000629551 | zanubrutinib |
| C000729508 | orelabrutinib |
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