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The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR1459 + YY-20394 (Stage 1) | Experimental |
| |
| SHR1459 + YY-20394 (Stage 2) | Experimental |
| |
| GemOx (Stage 2) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1459 ;YY-20394 | Drug | SHR1459 plus YY-20394 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: MTD (Maximum tolerated dose)or RP2D(Recommended Phase II Dose) of SHR1459 and YY-20394; | Minimum observation period is 28 days for the maximum dose cohort | |
| Stage 2: Overall response rate (ORR) | 8 weeks after last patient first visit (LPFV) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | At every treatment and follow up visit until disease progression. Expected to be for up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwei Wang | Contact | 021-61053363 | weiwei.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C508870 | gemcitabine-oxaliplatin regimen |
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Parallel Assignment
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| SHR1459 ;YY-20394 |
| Drug |
SHR1459 plus YY-20394 |
|
| Gemcitabine-Oxaliplatin | Drug | Gemcitabine-Oxaliplatin |
|
| 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 |