A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.

Official Title
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A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

Conditions
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B-Cell Lymphoma

Intervention / Treatment
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* Biological: GB241
* Biological: Rituximab


Participation Criteria
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Eligibility Criteria
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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

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: GB241<br>GB241:375 mg/m2, iv, one infusion | Biological: GB241<br>* Single intravenous infusion (IV) 375 mg/m2<br>|
| Active Comparator: Rituximab<br>Rituximab: 375 mg/m2, iv, one infusion | Biological: Rituximab<br>* Single intravenous infusion (IV) 375 mg/m2<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 GB241 and rituximab concentrations |  | 85 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GB241, Rituximab, B-cell Lymphoma