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

Nanjing Yoko Biomedical

Status and phase

Completed

Phase 1

Conditions

B-Cell Lymphoma

Treatments

Biological: Rituximab

Biological: GB241

Study type

Interventional

Funder types

Industry

Identifiers

NCT03003039

GB241NHL1

Details and patient eligibility

About

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

Enrollment

85 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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