A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
- Registration Number
- NCT02456207
- Lead Sponsor
- Sinocelltech Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- aged from 18 to 75 years;
- having histologically confirmed NHL expressing CD20 antigen;
- having obtained CR (complete remission) or CRu (uncertain complete remisson) after the prior therapy;
- ECOG performance status of 0 to 1
- expected survival of at least ≥ 3 months;
- signed an informed consent form which was approved by the institutional review board of the respective medical center .
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental SCT400 SCT400:375 mg/m2, iv, one infusion Active Comparator Rituximab Rituximab: 375 mg/m2, iv, one infusion
- Primary Outcome Measures
Name Time Method Area under the curve (AUC) for SCT400 and rituximab concentrations 85 days
- Secondary Outcome Measures
Name Time Method Comparison of AEs between the two study arms 85 days Comparison of HACA between the two study arms 85 days Change from baseline of CD19+ , CD20+ B-cells 85 days 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
Trial Locations
- Locations (1)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China