B-Cell Lymphoma Clinical Trial
Official title:
A Multicenter, Randomized, Double-blinded, Parallel Controlled Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients
| Verified date | June 2020 |
| Source | Innovent Biologics (Suzhou) Co. Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
| Status | Completed |
| Enrollment | 181 |
| Est. completion date | October 16, 2019 |
| Est. primary completion date | March 21, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: 1. CD20-positive B-cell lymphoma. 2. 18 years to 65 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Signed an informed consent. 5. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy. Exclusion Criteria: 1. Participation in another interventional clinical trial in the past 28 days. 2. Known allergic reactions against monoclonal antibody or rituximab. 3. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months. 4. Blood concentration of Rituximab>24ug/ml. 5. HIV positive patients. 6. HCV antigen and antibody positive. 7. Acute and chronic hepatitis B virus infection. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing cancer hospital | Beijing | Beijing |
| China | Peking University third hospital | Beijing | Beijing |
| China | The 307th Hospital of Military Medical Sciences | Beijing | Beijing |
| China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
| China | Xiangya Hospital of Central South University | Changsha | Hunan |
| China | West China Hospital,Sichuan University | Chengdu | Sichuan |
| China | Harbin Medical University Cancer Hospital | Haerbin | Heilongjiang |
| China | The First Affiliated Hospital Zhejiang University | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Jiangsu province people's hospital | Nanjing | Jiangsu |
| China | Tianjin People's Hospital | Tianjin | Tianjin |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Innovent Biologics (Suzhou) Co. Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | AUC0-inf of IBI301 and rituximab | 91 days | ||
| Secondary | Peak Plasma Concentration (Cmax) | 91 days | ||
| Secondary | Percentage and absolute value of CD19+ | 91 days | ||
| Secondary | Percentage and absolute value of CD20+ B-cell | 91 days | ||
| Secondary | Positive rate of ADA | 91 days | ||
| Secondary | Positive rate of NAb | 91 days | ||
| Secondary | Safety profiles | Including AE type?incidence rate?severity and drug- related | up to 1 year | |
| Secondary | Area under the plasma concentration versus time curve (AUC) | 91days | ||
| Secondary | AUC(0-t) of IBI301 and rituximab | 91 days |
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