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This is a multicenter, randomized, open-label, phase 3 clinical study to evaluate the efficacy of SHR-A1912 combined with R-GemOx in relapsed refractory diffuse large B-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1912 combined with Rituximab + Gemcitabine + Oxaliplatin | Experimental |
| |
| Rituximab + Gemcitabine + Oxaliplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1912 Injection | Drug | SHR-A1912 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CRR) | Up to 1 years following the first dose of the last enrolled patient. | |
| Overall survival (OS) | Up to 5 years following the first dose of the last enrolled patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Up to 5 years following the first dose of the last enrolled patient. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengbo Zhao | Contact | +86-0518-82342973 | mengbo.zhao@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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| Rituximab Injection | Drug | Rituximab injection. |
|
| Gemcitabine Hydrochloride for Injection | Drug | Gemcitabine hydrochloride for injection. |
|
| Oxaliplatin Injection | Drug | Oxaliplatin injection. |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-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 |
|---|---|
| D000069283 | Rituximab |
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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