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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 : Recruiting
First Posted : October 26, 2016
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
Study Start Date : November 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: IBI301 Drug: IBI301
IBI301 375mg/㎡

Active Comparator: Rituximab Drug: Rituximab
Rituximab 375mg/㎡




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 ]


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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.

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


Contacts
Contact: Chao Zhang 008651269566088 ext 8066 chao.zhang@innoventbio.com

Locations
China, Beijing
Beijing cancer hospital Not yet recruiting
Beijing, Beijing, China
Contact: Jun Zhu         
Peking University third hospital Recruiting
Beijing, Beijing, China
Contact: Xiaoyan Ke         
The 307th Hospital of Military Medical Sciences Recruiting
Beijing, Beijing, China
Contact: Hang Su         
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Haerbin, Heilongjiang, China
Contact: qingyuan Zhang         
China, Henan
The First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, Henan, China
Contact: Mingzhi Zhang         
China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Jing Liu         
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
Contact: Xielan Zhao         
China, Jiangsu
Jiangsu province people's hospital Recruiting
Nanjing, Jiangsu, China
Contact: Wei Xu         
China, Sichuan
West China Hospital,Sichuan University Recruiting
Chengdu, Sichuan, China
China, Tianjin
Tianjin People's Hospital Recruiting
Tianjin, Tianjin, China
Contact: Huaqing Wang         
China, Zhejiang
The First Affiliated Hospital Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Xiaohong Zhang         
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Investigators
Principal Investigator: Lugui Qiu Hematology Hospital of Chinese Academy of Medical Sciences

Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT02945215     History of Changes
Other Study ID Numbers: CIBI301A201
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antirheumatic Agents