A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.

Sinocelltech Ltd.0 sites15 target enrollmentMay 2012

ConditionsB-cell Non Hodgkin's Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-cell Non Hodgkin's Lymphoma
Sponsor: Sinocelltech Ltd.
Enrollment: 15
Primary Endpoint: Number of participants with infusion-related reaction and with drug-related adverse events.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

July 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sinocelltech Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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