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

B-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003039
• Other study ID #: GB241NHL1
• Status: Completed
• Phase: Phase 1
• Start date: June 5, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: March 2021
• Source: Nanjing Yoko Biomedical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• GB241
Single intravenous infusion (IV) 375 mg/m2
• Rituximab
Single intravenous infusion (IV) 375 mg/m2

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Yoko Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) for GB241 and rituximab concentrations		85 days
Secondary	AUC for GB241 and rituximab concentrations		1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Secondary	Maximum observed concentration of the GB241 and rituximab		85 days
Secondary	Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms		85 days
Secondary	Comparison of AEs between the two study arms		85 days
Secondary	Comparison of the incidence rate of HACA(host anti-chimeric antibody) between the two study arms		85 days