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The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL. The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab Biosimilar HLX01 in Combination With CHOP | Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL. | ||
| MabThera in Combination With CHOP | MabThera in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL. |
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| Measure | Description | Time Frame |
|---|---|---|
| overall survival | The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL. | up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL. | up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who have participated in Phase III study. Phase III study(NCT02787239)was rituximab biosimilar HLX01 and MabThera in patients with diffuse large B-cell lymphoma.
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, Doctor | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | China |
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| 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 |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |