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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGN-40
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large B-Cell, Diffuse focused on measuring Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic-Arizona
  • University of California Los Angeles
  • Stanford University Medical Center
  • Sharp Healthcare
  • Georgetown University
  • Northwestern University
  • Rush University Medical Center
  • Mayo Clinic-Rochester
  • Washington University School of Medicine
  • Weill Medical College of Cornell University
  • Charleston Hematology Oncology Associates, PA
  • Swedish Cancer Institute
  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.

Secondary Outcome Measures

Progression-free survival, disease-free survival, and overall survival.
Adverse events, laboratory values, and anti-drug antibody immune responses.
PK profile.

Full Information

First Posted
February 14, 2007
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00435916
Brief Title
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma
Official Title
A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin
Keywords
Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SGN-40
Other Intervention Name(s)
dacetuzumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
Time Frame
Every 1 or 2 months
Secondary Outcome Measure Information:
Title
Progression-free survival, disease-free survival, and overall survival.
Time Frame
Study duration
Title
Adverse events, laboratory values, and anti-drug antibody immune responses.
Time Frame
Within 3 weeks of final infusion
Title
PK profile.
Time Frame
Within 3 weeks of final infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Whiting, PharmD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic-Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mayo Clinic-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24919462
Citation
de Vos S, Forero-Torres A, Ansell SM, Kahl B, Cheson BD, Bartlett NL, Furman RR, Winter JN, Kaplan H, Timmerman J, Whiting NC, Drachman JG, Advani R. A phase II study of dacetuzumab (SGN-40) in patients with relapsed diffuse large B-cell lymphoma (DLBCL) and correlative analyses of patient-specific factors. J Hematol Oncol. 2014 Jun 12;7:44. doi: 10.1186/1756-8722-7-44.
Results Reference
result

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

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