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This is an open-label, phase Ib study evaluating the combination treatment of sintilimab and linperlisib in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma (NKTCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab and Linperlisib Combination Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab and Linperlisib Combination Treatment | Drug | Sintilimab administered via intravenous infusion; Linperlisib administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose-limiting toxicity | Cycle 1 (21 days) |
| RP2D | Phase II Recommended Dose | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To investigate the antitumor efficacy | Up to 24 weeks |
| AE and SAE | Number of participants with adverse events (AE) and severe adverse events (SAE) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, MD. PhD. | Contact | 0086-20-87342823 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Universitiy Cancer Center | Recruiting | Guangzhou | Guangdong | 51000 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| Up to 24 weeks |
| 2-year Progression-free survival(PFS) | To investigate the antitumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment |
| 2-year Overall survival(OS) | To investigate the antitumor efficacy | Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment |