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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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02945215
Collaborator
(none)
181
Enrollment
12
Locations
2
Arms
34.1
Actual Duration (Months)
15.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Dec 13, 2016
Actual Primary Completion Date :
Mar 21, 2019
Actual Study Completion Date :
Oct 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: IBI301

Drug: IBI301
IBI301 375mg/㎡
Active Comparator: Rituximab

Drug: Rituximab
Rituximab 375mg/㎡

Outcome Measures

Primary Outcome Measures

  1. AUC0-inf of IBI301 and rituximab [91 days]

Secondary Outcome Measures

  1. Peak Plasma Concentration (Cmax) [91 days]

  2. Percentage and absolute value of CD19+ [91 days]

  3. Percentage and absolute value of CD20+ B-cell [91 days]

  4. Positive rate of ADA [91 days]

  5. Positive rate of NAb [91 days]

  6. Safety profiles [up to 1 year]

    Including AE type、incidence rate、severity and drug- related

  7. Area under the plasma concentration versus time curve (AUC) [91days]

  8. AUC（0-t） of IBI301 and rituximab [91 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing cancer hospital Beijing Beijing China
2 Peking University third hospital Beijing Beijing China
3 The 307th Hospital of Military Medical Sciences Beijing Beijing China
4 Harbin Medical University Cancer Hospital Haerbin Heilongjiang China
5 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
6 The Third Xiangya Hospital of Central South University Changsha Hunan China
7 Xiangya Hospital of Central South University Changsha Hunan China
8 Jiangsu province people's hospital Nanjing Jiangsu China
9 West China Hospital,Sichuan University Chengdu Sichuan China
10 Tianjin People's Hospital Tianjin Tianjin China
11 The First Affiliated Hospital Zhejiang University Hangzhou Zhejiang China
12 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

  • Principal Investigator: Lugui Qiu, Hematology Hospital of Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT02945215
Other Study ID Numbers:
  • CIBI301A201
First Posted:
Oct 26, 2016
Last Update Posted:
Sep 1, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Rituximab

Study Results

No Results Posted as of Sep 1, 2020