B-cell Non Hodgkin's Lymphoma
Conditions
Keywords
Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics
Brief summary
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
Interventions
BIOLOGICALChimeric anti-CD20 monoclonal antibody
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* aged from 18 to 75 years * having histologically confirmed NHL expressing CD20 antigen * having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months * signed an informed consent form which was approved by the institutional review board of the respective medical center
Exclusion criteria
* single measurable lesion ≥7 cm in diameter * with serious hematologic dysfunction (white blood cell count of \<3.0×103/μL; absolute neutrophil count of \<1.5×103/ μL; platelet count of \< 75×103/μL; hemoglobin level of \< 8.0 g/dL; serum immunoglobulin G(IgG) level of \<600 mg/dL);, hepatic dysfunction (total bilirubin level of \> 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of \> 1.5×ULN ) * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy * had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment * had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry * with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease * having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus * with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with infusion-related reaction and with drug-related adverse events. | up to 27 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Area Under the plasma concentration versus time curve (AUC) of SCT400 | prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose |
Other
| Measure | Time frame |
|---|---|
| Time to disease progression | up to 27 weeks |
Outcome results
None listed