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

NCT ID: NCT03003039

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2019-05-20

Brief Summary

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

Conditions

B-Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GB241

GB241:375 mg/m2, iv, one infusion

Group Type: EXPERIMENTAL

GB241

Intervention Type: BIOLOGICAL

Single intravenous infusion (IV) 375 mg/m2

Rituximab

Rituximab: 375 mg/m2, iv, one infusion

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: BIOLOGICAL

Single intravenous infusion (IV) 375 mg/m2

Interventions

GB241

Single intravenous infusion (IV) 375 mg/m2

Intervention Type: BIOLOGICAL

Rituximab

Single intravenous infusion (IV) 375 mg/m2

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

GB241NHL1

Identifier Type: -

Identifier Source: org_study_id