Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

December 17, 2014 updated by: Seagen Inc.

A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic-Arizona
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Palo Alto, California, United States, 94305
        • Stanford University Medical Center
      • San Diego, California, United States, 92123
        • Sharp HealthCare
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic-Rochester
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology Associates, PA
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of DLBCL.
  • Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent.
  • Progression or relapse since most recent therapy.
  • At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT.

Exclusion Criteria:

  • Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma.
  • Primary refractory disease.
  • Received an allogenic stem cell transplant.

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: 1
Drug: SGN-40
1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.
Other Names:
  • dacetuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time Frame: Every 1 or 2 months
Every 1 or 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival, disease-free survival, and overall survival.
Time Frame: Study duration
Study duration
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time Frame: Within 3 weeks of final infusion
Within 3 weeks of final infusion
PK profile.
Time Frame: Within 3 weeks of final infusion
Within 3 weeks of final infusion

Collaborators and Investigators

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

Sponsor

Seagen Inc.

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Nancy Whiting, PharmD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

February 14, 2007

First Submitted That Met QC Criteria

February 15, 2007

First Posted (Estimate)

February 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 7, 2015

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SG040-0004

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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