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This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisatoclax Combined with R-CHOP or Pola-R-CHP | Experimental | In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study. In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CHOP | Drug | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) for Phase 1b | To identify the DLT | The first cycle (each cycle is 21 days) after lisaftoclax administration. |
| Complete response rate (CRR) for Phase 2 | The proportion of patients who achieve complete response (CR) | Up to 8 cycles (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients who achieve complete response (CR) or partial response (PR) | Up to 8 cycles (each cycle is 21 days) |
| Duration of Response (DOR) | To investigate the preliminary anti-tumor efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 02087342823 | caiqq@sysucc.org.cn | |
| Yi Xia, MD. PhD. | Contact | 02087342823 | xiayi@sysucc.org.cn |
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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 |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C571759 | R-CHOP protocol |
| C000726452 | Lisaftoclax |
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| POLA-R-CHP | Drug | Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone |
|
| Lisaftoclax | Drug | Lisaftoclax (400 mg or 600 mg) is added from the second cycle of chemotherapy. |
|
| Up to 5 years |
| Progression-free survival (PFS) | To investigate the preliminary anti-tumor efficacy | Up to 5 years |
| Overall survival (OS) | To investigate the preliminary anti-tumor efficacy | Up to 5 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |