A Pivotal Open-Label Trial of SGN-35 for Hodgkin Lymphoma - Full Text View

Sponsor:	Seattle Genetics, Inc.
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00848926

Purpose

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of SGN-35 as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Condition	Intervention	Phase
Disease, Hodgkin	Drug: SGN-35	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin's Lymphoma (HL)

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

U.S. FDA Resources

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of response, progression-free survival, overall survival [ Time Frame: Every 3 months until death or study closure ] [ Designated as safety issue: No ]
Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
PK profile [ Time Frame: Every 2 or 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: SGN-35 Every 21 days by IV infusion (1.8 mg/kg)

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm as documented by spiral CT.
At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

Previous treatment with SGN-35.
Previously received an allogeneic transplant.
Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
History of another primary malignancy that has not been in remission for at least 3 years.
Known cerebral/meningeal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848926

Hide Study Locations

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
University of California at Los Angeles
Los Angeles, California, United States, 90095
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Medical Center Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14642
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Belgium
Cliniques Universitaires UCL de Mont-Goddine
Yvoir, Belgium, 5530
UZ Gasthuisberg
Leuven, Belgium, 3000
Canada, British Columbia
B.C Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
France
Hospital Saint Louis
Paris, France, 75475
Centre Henri Becquerel
Rouen, France, 76038
Institut Paoli Calmettes
Marseille, France, 13273
Italy
Instituto di Ematologia ed Oncologia Medica
Bologna, Italy, 40138

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Eric Sievers, MD

Seattle Genetics, Inc.

More Information

No publications provided

Responsible Party:	Seattle Genetics ( Eric Sievers, MD )
Study ID Numbers:	SG035-0003
Study First Received:	February 18, 2009
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00848926 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Hematologic Diseases

Lymphoma
monomethylauristatin E
Drug Therapy
Immunotherapy

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on November 27, 2009