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This is an open-label, multi-center clinical study to evaluate the efficacy and safety of XNW5004 tablets in subjects with R/R PTCL. The study plans to enroll approximately 50 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XNW5004 | Experimental | XNW5004 tablets Oral administration, twice daily, with a 28-day continuous dosing as one cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XNW5004 tablets | Drug | XNW5004 will be administered orally as tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by independent review committee (IRC) | Percentage of participants achieving complete response (CR) and partial response (PR) in the study. | 24 mounths |
| Measure | Description | Time Frame |
|---|---|---|
| ORR assessed by investigator | Percentage of participants achieving complete response (CR) and partial response (PR). | 24 mounths |
| Progression free survival | time from the first dose of to the first disease progression(PD) or death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiming Li M.D. | Contact | 13719189172 | lizhm@sysucc.org.cn | |
| Hui Zhou M.D. | Contact | 13975879796 | zhouhui@hnca.org.cn |
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| 24 mounths |
| Time to Response | time from the first dose of XNW5004 to first CR or PR | around 4 months |
| Duration of response | time from the first CR or PR to the first PD or death | 24 mounths |
| Overall survival | time from the fist dose of XNW5004 to death | around 5 years |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |