NCT00435916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 7, 2015

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

February 14, 2007

Last Update Submit

December 17, 2014

Conditions

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

Keywords

Antigens, CD40Antibody, MonoclonalLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHematologic DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersLymphoma

Outcome Measures

Primary Outcomes (1)

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

    Every 1 or 2 months

Secondary Outcomes (3)

  • Progression-free survival, disease-free survival, and overall survival.

    Study duration

  • Adverse events, laboratory values, and anti-drug antibody immune responses.

    Within 3 weeks of final infusion

  • PK profile.

    Within 3 weeks of final infusion

Study Arms (1)

1

EXPERIMENTAL
Drug: SGN-40

Interventions

SGN-40DRUG

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.

Also known as: dacetuzumab
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Mayo Clinic-Arizona

Scottsdale, Arizona, 85259, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

Sharp Healthcare

San Diego, California, 92123, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29403, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related 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) and correlative analyses of patient-specific factors. J Hematol Oncol. 2014 Jun 12;7:44. doi: 10.1186/1756-8722-7-44.

    PMID: 24919462RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHematologic DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersLymphoma

Interventions

dacetuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-CellNeoplasms by Histologic TypeNeoplasmsHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Nancy Whiting, PharmD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 16, 2007

Study Start

December 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 7, 2015

Record last verified: 2014-12

Locations

US(14)