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

NCT ID: NCT02206308

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-07-31

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

Conditions

B-cell Non Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

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;

Group Type: EXPERIMENTAL

Chimeric anti-CD20 monoclonal antibody

Intervention Type: BIOLOGICAL

Interventions

Chimeric anti-CD20 monoclonal antibody

Intervention Type: BIOLOGICAL

Other Intervention Names

SCT400

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan kai Shi, PhD

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China

Other Identifiers

SCT400NHLI

Identifier Type: -

Identifier Source: org_study_id