Trial | NCT02206308  Report issue

Title

Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rituximab ...

  • Study Participants

    15
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
Study Started
May 31
2012
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Aug 01
2014
Estimate

Biological Chimeric anti-CD20 monoclonal antibody

  • Other names: SCT400

single arm Experimental

Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses;

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
No Results Posted