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This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XNW5004 ; Chidamide placebo | Drug | XNW5004 + Chidamide placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by BICR | 24 mounths |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | 24 mounths | |
| Time to Response | around 4 months | |
| Duration of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqin Song | Contact | 010-88196118 | SongYQ_VIP@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| XNW5004 placebo; Chidamide |
| Drug |
XNW5004 placebo + Chidamide |
|
| 24 mounths |
| Overall survival | around 5 years |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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