Clinical trial NCT03003039: A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Official title: A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B-Cell Lymphoma
Keywords: GB241
Rituximab
B-cell Lymphoma
Lead sponsor: Nanjing Yoko Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 \<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

Primary outcomes:
measure: Area under the curve (AUC) for GB241 and rituximab concentrations
timeFrame: 85 days
Secondary outcomes:
measure: AUC for GB241 and rituximab concentrations
timeFrame: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Maximum observed concentration of the GB241 and rituximab
timeFrame: 85 days
measure: Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
timeFrame: 85 days
measure: Comparison of AEs between the two study arms
timeFrame: 85 days
measure: Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
timeFrame: 85 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References: