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

Phase 2

Completed

• Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse
• Interventions: Drug: SGN-40

• Registration Number: NCT00435916
• Lead Sponsor: Seagen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-14
• Study First Submitted QC: 2007-02-15
• Study First Posted: 2007-02-16
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2011-05-24
• Disposition First Submitted QC: 2011-05-24
• Disposition First Posted: 2011-06-02
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SGN-40	-

Primary Outcome Measures

Name	Time	Method
Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.	Every 1 or 2 months

Secondary Outcome Measures

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

Trial Locations

Locations (14)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Charleston Hematology Oncology Associates, PA; 🇺🇸 Charleston, South Carolina, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Mayo Clinic-Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic-Arizona; 🇺🇸 Scottsdale, Arizona, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States