A Phase 2 Open Label Trial of SGN-35 for Systemic Anaplastic Large Cell Lymphoma

This study is currently recruiting participants.

Verified by Seattle Genetics, Inc., May 2009

First Received: March 19, 2009 Last Updated: May 1, 2009 History of Changes

Sponsored by:	Seattle Genetics, Inc.
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00866047

Purpose

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

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic	Drug: SGN-35	Phase II

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

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:	55
Study Start Date:	March 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: 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 systemic ALCL who have previously received front line chemotherapy.
Documented anaplastic lymphoma kinase (ALK) status.
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 and measurable disease of at least 1.5 cm as documented by both PET and spiral CT.
Received any previous ASCT at least 12 weeks (3 months) prior.
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.
Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
Known cerebral/meningeal disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866047

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Locations

United States, Colorado
Rocky Mountain Cancer Center	Recruiting
Denver, Colorado, United States, 80218
Contact: Karen Morris 303-285-5004 karen.morris@usoncology.com
Principal Investigator: Jeffrey Matous, MD
United States, Florida
University of Miami	Recruiting
Miami, Florida, United States, 33136
Contact: Francine Coleman 305-243-8226 fcoleman@med.miami.edu
Principal Investigator: Joseph Rosenblatt
United States, Minnesota
Mayo Clinic - Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office 507-538-7623
Principal Investigator: Steven Ansell, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Sarah Larson 314-362-3257 salarson@dom.wustl.edu
Principal Investigator: Nancy Bartlett, MD
United States, Texas
Baylor Sammons Cancer Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Mirjana Tadic-Ovcina 214-820-4072 mirjanao@baylorhealth.edu
Principal Investigator: Robert B Berryman
University of Texas MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Linda Lacerte 713-792-9455 llacert@mdanderson.org
Principal Investigator: Barbara Pro
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98109
Contact: Jennifer Roden 206-288-6721 jener@seattlecca.org
Principal Investigator: Andrei Shustov

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Dana Kennedy, PharmD

Seattle Genetics, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Seattle Genetics, Inc ( Dana Kennedy, PharmD )
Study ID Numbers:	SG035-0004
Study First Received:	March 19, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00866047 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic

monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hematologic Diseases
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphatic Diseases
Antibodies
B-cell Lymphomas

Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, Large-cell
Anaplastic Large Cell Lymphoma
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Neoplasms by Histologic Type

Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009