A 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
NCT ID: NCT02945215
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
181 participants
INTERVENTIONAL
2016-12-13
2019-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IBI301
IBI301
IBI301 375mg/㎡
Rituximab
Rituximab
Rituximab 375mg/㎡
Interventions
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IBI301
IBI301 375mg/㎡
Rituximab
Rituximab 375mg/㎡
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lugui Qiu
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences
Locations
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Beijing cancer hospital
Beijing, Beijing Municipality, China
Peking University third hospital
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
Countries
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Other Identifiers
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CIBI301A201
Identifier Type: -
Identifier Source: org_study_id
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