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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435916
• Other study ID #: SG040-0004
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2007
• Last updated: December 17, 2014
• Start date: December 2006
• Est. completion date: January 2009

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of California Los Angeles	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	Weill Medical College of Cornell University	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Mayo Clinic-Rochester	Rochester	Minnesota
United States	Sharp Healthcare	San Diego	California
United States	Mayo Clinic-Arizona	Scottsdale	Arizona
United States	Swedish Cancer Institute	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.		Every 1 or 2 months	No
Secondary	Progression-free survival, disease-free survival, and overall survival.		Study duration	No
Secondary	Adverse events, laboratory values, and anti-drug antibody immune responses.		Within 3 weeks of final infusion	Yes
Secondary	PK profile.		Within 3 weeks of final infusion	No