B-cell Non Hodgkin's Lymphoma
Conditions
Brief summary
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of SCT400 versus rituximab (MabThera®) in patients with CD20+ B-cell Non-Hodgkin's Lymphoma. The secondary objective of the study is to evaluate the pharmacodynamics (PD) and safety of SCT400 versus rituximab (MabThera®), as well as the presence of human anti-chimeric antibodies (HACA).
Interventions
DRUGSCT400
DRUGRituximab
Sponsors
Sinocelltech 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
1. aged from 18 to 75 years; 2. having histologically confirmed NHL expressing CD20 antigen; 3. having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy; 4. ECOG performance status of 0 to 1 5. expected survival of at least ≥ 3 months; 6. signed an informed consent form which was approved by the institutional review board of the respective medical center .
Exclusion criteria
1. had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment; 2. having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or have not recovered from significant toxicities of prior therapy; 3. participating in other clinical trial within 30 days before enrolment; 4. 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); 5. had received live vaccine within 4 weeks prior to study entry; 6. with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related lymphoma; or active opportunistic infection, a serious nonmalignant disease; 7. 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, 8. recent major surgery (within 28 days prior to study entry ); 9. with a history of allergic reaction or protein product allergy including murine proteins; 10. pregnant or lactating or not accepted birth control methods including male patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) for SCT400 and rituximab concentrations | 85 days |
Secondary
| Measure | Time frame |
|---|---|
| AUC for SCT400 and rituximab concentrations | 1 week ,2 weeks, 4 weeks, 8 weeks and 12 weeks |
| Maximum observed concentration of the SCT400 and rituximab | 85 days |
| Change from baseline of CD19+ , CD20+ B-cells | 85 days |
| Comparison of AEs between the two study arms | 85 days |
| Comparison of HACA between the two study arms | 85 days |
Countries
China
Outcome results
None listed