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The study is being conducted to evaluate the safety and efficacy of SHR2554 with CHOP/CHOEP in treatment- naïve peripheral T-cell lymphoma.
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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 |
|---|---|---|---|---|
| SHR2554/CHOP | Drug | SHR2554 with CHOP |
| |
| SHR2554/CHOEP |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: incidence and severity of adverse events (AEs) | Ib phase | through study completion, an average of about 6 months |
| Overall response rate (ORR) | II phase | 90 days since the date of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration | Ib phase | Day 1 of cycle 1 to day 1 of cycle 4 (21 days/cycle) |
| Progression Free Survival (PFS) | II phase | through study completion, an average of about 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Wu | Contact | 0518-82342973 | yang.wu.yw96@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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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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SHR2554 with CHOP/CHOEP.
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| Drug |
SHR2554 with CHOEP |
|
| Overall Survival (OS) | II phase | 2 years since the date of first dose |
| Duration of response (DOR) | II phase | through study completion, an average of about 6 months |
| Incidence and severity of adverse events (AEs) | II phase | through study completion, an average of about 6 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |