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

July 31, 2014 updated by: Sinocelltech Ltd.

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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;
Biological: Chimeric anti-CD20 monoclonal antibody
Other Names:
  • SCT400

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with infusion-related reaction and with drug-related adverse events.
Time Frame: up to 27 weeks
up to 27 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the plasma concentration versus time curve (AUC) of SCT400
Time Frame: prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose

Other Outcome Measures

Outcome Measure
Time Frame
Time to disease progression
Time Frame: up to 27 weeks
up to 27 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 2014

Study Record Updates

Last Update Posted (Estimate)

August 1, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCT400NHLI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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