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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

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ClinicalTrials.gov Identifier: NCT02945215
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Study Description
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Brief Summary:
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma

Condition or disease Intervention/treatment Phase
B-Cell Lymphoma Drug: IBI301 Drug: Rituximab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2016
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : October 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: IBI301 Drug: IBI301
IBI301 375mg/㎡
Active Comparator: Rituximab Drug: Rituximab
Rituximab 375mg/㎡


Outcome Measures
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Primary Outcome Measures :
  1. AUC0-inf of IBI301 and rituximab [ Time Frame: 91 days ]

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: 91 days ]
  2. Percentage and absolute value of CD19+ [ Time Frame: 91 days ]
  3. Percentage and absolute value of CD20+ B-cell [ Time Frame: 91 days ]
  4. Positive rate of ADA [ Time Frame: 91 days ]
  5. Positive rate of NAb [ Time Frame: 91 days ]
  6. Safety profiles [ Time Frame: up to 1 year ]
    Including AE type、incidence rate、severity and drug- related

  7. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 91days ]
  8. AUC（0-t） of IBI301 and rituximab [ Time Frame: 91 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945215


Locations
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China, Beijing
Beijing cancer hospital
Beijing, Beijing, China
Peking University third hospital
Beijing, Beijing, China
The 307th Hospital of Military Medical Sciences
Beijing, Beijing, China
China, Heilongjiang
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
China, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Jiangsu
Jiangsu province people's hospital
Nanjing, Jiangsu, China
China, Sichuan
West China Hospital,Sichuan University
Chengdu, Sichuan, China
China, Tianjin
Tianjin People's Hospital
Tianjin, Tianjin, China
China, Zhejiang
The First Affiliated Hospital Zhejiang University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
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Principal Investigator: Lugui Qiu Hematology Hospital of Chinese Academy of Medical Sciences
More Information
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT02945215    
Other Study ID Numbers: CIBI301A201
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents