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This is a single-arm, open-label, multicenter phase II study evaluating sintilimab, pegaspargase, and selinexor followed by radiotherapy as first-line treatment for patients with newly diagnosed stage I/II extranodal natural killer/T-cell lymphoma (ENKTL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab, pegaspargase, and selinexor | Experimental | Patients will receive induction therapy with sintilimab, pegaspargase, and selinexor every 21 days for up to 4 cycles, followed by radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab will be given at 200 mg by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | The proportion of patients who achieve complete response at the end of radiotherapy, as assessed according to Lugano 2014 response criteria. | Up to approximately 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The proportion of patients who achieve complete response or partial response, as assessed according to Lugano 2014 response criteria. | Up to approximately 6 months |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai | Contact | +8618353201165 | caiqq@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | 广东省 - Guangdong Sheng | 510060 | China |
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| Pegaspargase | Drug | Pegaspargase will be given at 2000 U/m², with a maximum total dose of 3750 U, by intramuscular injection. |
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| Selinexor | Drug | Selinexor will be given orally once weekly at 60mg. |
|
| radiotherapy | Radiation | Patients will receive induction treatment for up to 4 cycles, followed by radiotherapy. |
|
The time from enrollment to disease progression or death from any cause, whichever occurs first.
| Up to 3 years |
| Overall Survival (OS) | The time from enrollment to death from any cause. | Up to 3 years |
| Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE) | The incidence and severity of adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events. | Up to 30 days after the last study treatment |
| Change in Quality of Life | Quality of life will be assessed using the EORTC QLQ-C30 or FACT-G questionnaire. | Up to 3 years |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C042705 | pegaspargase |
| C585161 | selinexor |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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