NCT03003039CompletedPhase 1
A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Nanjing Yoko Biomedical Co., Ltd.1 site in 1 country85 target enrollmentStarted: June 5, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Area under the curve (AUC) for GB241 and rituximab concentrations
Study Overview
Brief Summary
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab concentrations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Area under the curve (AUC) for GB241 and rituximab concentrations
Time Frame: 85 days
Secondary Outcomes
- Maximum observed concentration of the GB241 and rituximab(85 days)
- AUC for GB241 and rituximab concentrations(1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks)
- Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms(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)
Investigators
Study Sites (1)
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