Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
Lead Sponsor:
Sinocelltech Ltd.
Conditions:
B-cell Non Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02206308
Start Date
May 1 2012
End Date
July 1 2013
Last Update
August 1 2014
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