Clinical trial NCT02945215: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B-Cell Lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-26
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: AUC0-inf of IBI301 and rituximab
timeFrame: 91 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 91 days
measure: Percentage and absolute value of CD19+
timeFrame: 91 days
measure: Percentage and absolute value of CD20+ B-cell
timeFrame: 91 days
measure: Positive rate of ADA
timeFrame: 91 days
measure: Positive rate of NAb
timeFrame: 91 days
measure: Safety profiles
timeFrame: up to 1 year
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 91days
measure: AUC（0-t） of IBI301 and rituximab
timeFrame: 91 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cancer hospital
state: Beijing
city: Beijing
country: China
facility: Peking University third hospital
state: Beijing
city: Beijing
country: China
facility: The 307th Hospital of Military Medical Sciences
state: Beijing
city: Haerbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu province people's hospital
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Lugui Qiu
role: PRINCIPAL_INVESTIGATOR
References: