B-Cell Lymphoma
Conditions
Keywords
GB241, Rituximab, B-cell Lymphoma
Brief summary
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.
Interventions
BIOLOGICALGB241
Single intravenous infusion (IV) 375 mg/m2
BIOLOGICALRituximab
Single intravenous infusion (IV) 375 mg/m2
Sponsors
Nanjing Yoko Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* having histologically confirmed NHL expressing CD20 antigen * having obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy * signed an informed consent form which was approved by the institutional review board of the respective medical center * aged from 18 to 75 years * ECOG performance status of 0 to 1 * expected survival of at least ≥ 3 months
Exclusion criteria
* had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy * participating in other clinical trial within 30 days before enrolment * with serious hematologic dysfunction (white blood cell count of \<3.0×103/uL; absolute neutrophil count of \<1.5×103/ uL; platelet count of \< 75×103/uL; hemoglobin level of \< 8.0 g/dL); hepatic dysfunction (total bilirubin level of \> 1.5×ULN; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN; renal dysfunction (serum creatinine level of \> 1.5×ULN ); and International normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT) \> 1.5 × ULN (unless on therapeutic coagulation) * had received live vaccine within 4 weeks prior to study entry * with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease * seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may participle following consultation with a hepatitis expert regarding monitoring and use of HBV antiviral therapy, and provided they agree to receive treatment as indicated * recent major surgery (within 28 days prior to study entry ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients * patients considered unsuitable by PI * previous malignant tumor except cured cervical cancer,basal cell carcinoma and squamous cell skin cancer * active opportunistic infections and other serious non neoplastic diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) for GB241 and rituximab concentrations | 85 days |
Secondary
| Measure | Time frame |
|---|---|
| AUC for GB241 and rituximab concentrations | 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks |
| Maximum observed concentration of the GB241 and rituximab | 85 days |
| Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms | 85 days |
| Comparison of AEs between the two study arms | 85 days |
| Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms | 85 days |
Countries
China
Outcome results
None listed