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

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Disease Information

Descriptive Information
Brief Title † A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Official Title †
Brief Summary The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Area under the curve (AUC) for GB241 and rituximab concentrations
Secondary Outcome Measure † AUC for GB241 and rituximab concentrations
Condition † B-Cell Lymphoma
Intervention † BiologicalGB241
Study Arms / Comparison Groups GB241 GB241:375 mg/m2, iv, one infusion Rituximab Rituximab: 375 mg/m2, iv, one infusion
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 80
Start Date † October 2016
Completion Date
Primary Completion Date March 2018
Eligibility Criteria † 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 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
Gender Both
Ages 18 Years - 75 Years
Accepts Healthy Volunteers No
Contacts †† xu tie, master, 86-18036618680, 15252822887@163.com
Location Countries † China
Administrative Information
NCT ID † NCT03003039
Organization ID GB241NHL1
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Nanjing Yoko Biomedical Co., Ltd.
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date December 2016
First Received Date † December 20, 2016
Last Updated Date December 23, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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