Clinical trial NCT00435916: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-02-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma.
timeFrame: Every 1 or 2 months
Secondary outcomes:
measure: Progression-free survival, disease-free survival, and overall survival.
timeFrame: Study duration
measure: Adverse events, laboratory values, and anti-drug antibody immune responses.
timeFrame: Within 3 weeks of final infusion
measure: PK profile.
timeFrame: Within 3 weeks of final infusion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic-Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Seagen Inc.
name: Nancy Whiting, PharmD
role: STUDY_DIRECTOR
References:
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.