A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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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).

Official Title
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A Phase II, Multi-center, Randomized and Open Study to Evaluate and Compare the PK, PD and Safety of SCT400 With Rituximab in Patients With CD20+ B-cell Non-Hodgkin's Lymphoma

Conditions
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B-cell Non Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: SCT400
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>SCT400:375 mg/m2, iv, one infusion | Drug: SCT400<br> <br> |
| Active Comparator: Active Comparator<br>Rituximab: 375 mg/m2, iv, one infusion | Drug: Rituximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) for SCT400 and rituximab concentrations |  | 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |