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

Sponsor

Nanjing Yoko Biomedical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03003039

Collaborator

(none)

Enrollment

Location

Arms

23.5

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
B-Cell Lymphoma	Biological: GB241 Biological: Rituximab	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 5, 2017

Actual Primary Completion Date :

May 20, 2019

Actual Study Completion Date :

May 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GB241 GB241:375 mg/m2, iv, one infusion	Biological: GB241 Single intravenous infusion (IV) 375 mg/m2
Active Comparator: Rituximab Rituximab: 375 mg/m2, iv, one infusion	Biological: Rituximab Single intravenous infusion (IV) 375 mg/m2

Arm

Intervention/Treatment

Experimental: GB241

GB241:375 mg/m2, iv, one infusion

Biological: GB241

Single intravenous infusion (IV) 375 mg/m2

Active Comparator: Rituximab

Rituximab: 375 mg/m2, iv, one infusion

Biological: Rituximab

Single intravenous infusion (IV) 375 mg/m2

Outcome Measures

Primary Outcome Measures

Area under the curve (AUC) for GB241 and rituximab concentrations [85 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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