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Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI301 | Experimental |
| |
| Rituximab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI301 | Drug | IBI301 375mg/㎡ |
| |
| Rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of IBI301 and rituximab | 91 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 91 days | |
| Percentage and absolute value of CD19+ | 91 days | |
| Percentage and absolute value of CD20+ B-cell |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing cancer hospital | Beijing | Beijing Municipality | China | |||
| Peking University third hospital |
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| Drug |
Rituximab 375mg/㎡ |
|
| 91 days |
| Positive rate of ADA | 91 days |
| Positive rate of NAb | 91 days |
| Safety profiles | Including AE type、incidence rate、severity and drug- related | up to 1 year |
| Area under the plasma concentration versus time curve (AUC) | 91days |
| AUC（0-t） of IBI301 and rituximab | 91 days |
| Beijing |
| Beijing Municipality |
| China |
| The 307th Hospital of Military Medical Sciences | Beijing | Beijing Municipality | China |
| Harbin Medical University Cancer Hospital | Haerbin | Heilongjiang | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Jiangsu province people's hospital | Nanjing | Jiangsu | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | China |
| Tianjin People's Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital Zhejiang University | Hangzhou | Zhejiang | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| 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 |
| 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 |
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