The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection.
This is a multi-center, randomized, double-blind, parallel controlled, single-dose study to evaluate the pharmacokinetic, safety and efficacy of 304 injection compared with rituximab injection. To avoid the impact of tumor burden on pharmacokinetics, this study will be conducted in CD20 positive B-cell non-Hodgkin lymphoma patients who have achieved CR/CRu status and have not yet deteriorated or relapsed. All patients will be randomly averagely entered into the experimental group and the control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Monoclonal antibodies, 100mg/10ml per injection
100mg/10ml per injection ,manufactured by Roche
The 307 Hospital of People's Liberation Army
Beijing, Beijing Municipality, China
RECRUITINGBeijing Luhe Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAUC [0-t]
To assess PK parameter of plasma 304 or rituximab: Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC \[0-t\])
Time frame: For 85 days
AUC [0-∞]
To assess PK parameter of plasma 304 or rituximab: Area under the concentration-time curve from time zero extrapolated to infinity (AUC \[0-∞\])
Time frame: For 85 days
Cmax
To assess PK parameter of plasma 304 or rituximab:Observed maximum plasma concentration (Cmax)
Time frame: For 85 days
tmax
To assess PK parameter of plasma 304 or rituximab:Time to Cmax (tmax)
Time frame: For 85 days
t1/2
To assess PK parameter of plasma 304 or rituximab:Elimination half-life (t1/2)
Time frame: For 85 days
MRT
To assess PK parameter of plasma 304 or rituximab:Mean residence time (MRT)
Time frame: For 85 days
Vz
To assess PK parameter of plasma 304 or rituximab:Apparent volume of distribution(Vz)
Time frame: For 85 days
CLz
To assess PK parameter of plasma 304 or rituximab:apparent clearance (CLz)
Time frame: For 85 days
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Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, China
RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, Heibei, China
RECRUITINGZhengzhou Central Hospital
Zhengzhou, Henan, China
RECRUITINGThe First Affiliated Hospita of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGWeihai Municipal Hospital
Weihai, Shandong, China
RECRUITINGTianjin Medical University Cancer Institute &Hospital
Tianjing, Tianjing, China
RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Zhejiang, China
RECRUITINGADA
To evaluate the incidence of anti-304 and anti-rituximab antibodies
Time frame: Up to 9 months
Adverse events
To evaluate the adverse events (incidence, severity, outcome, causality with the investigational drug, etc.).
Time frame: Up to 85 days