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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Disease, Hodgkin

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant


Inclusion Criteria:



- Patients with HL who have received ASCT in the previous 30-45 days

- Patients at high risk of residual HL post ASCT

- Histologically-confirmed HL

- ECOG of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Previous treatment with brentuximab vedotin

- Previously received an allogeneic transplant

- Patients who were determined to have a best clinical response of progressive disease
with salvage treatment immediately prior to ASCT

- History of another primary malignancy that has not been in remission for at least 3
years

- Post ASCT or current therapy with other systemic anti-neoplastic or investigational
agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Until disease progression or study closure

Safety Issue:

No

Principal Investigator

Naomi Hunder, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-005

NCT ID:

NCT01100502

Start Date:

April 2010

Completion Date:

April 2016

Related Keywords:

  • Disease, Hodgkin
  • Antigens, CD30
  • Antibody-Drug Conjugate
  • Antibodies, Monoclonal
  • Disease, Hodgkin
  • Drug Therapy
  • Hematologic Diseases
  • Immunotherapy
  • Lymphoma
  • Monomethylauristatin E
  • Hodgkin Disease
  • Lymphoma

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Medical Center Rochester, New York  14642
Hackensack University Medical Center Hackensack, New Jersey  07601
City of Hope National Medical Center Los Angeles, California  91010
Baylor University Medical Center Dallas, Texas  75246
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
Stanford Cancer Center Stanford, California  94305-5824
University of Minnesota Minneapolis, Minnesota  55455
Northwestern University Chicago, Illinois  60611
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
Johns Hopkins Medical Center Baltimore, Maryland  
Cancer Center of the Carolinas Greenville, South Carolina  29615
University of California at San Francisco San Francisco, California  94115
Northside Hospital Atlanta, Georgia  30342
Saint Francis Hospital Greenville, South Carolina  29601
New York University Cancer Institute New York, New York  10016
Colorado Blood Cancer Institute Denver, Colorado  80218
Karmanos Cancer Institute / Wayne State University Detroit, Michigan  48201
MD Anderson Cancer Center / University of Texas Houston, Texas  77030-4003
Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood, Illinois  60153
UNC Lineberger Comprehensive Cancer Center / University of North Carolina Chapel Hill, North Carolina  27599
University of Chicago Section of Hematology/Oncology Lymphoma Program Chicago, Illinois  60637-1470
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380 Indianapolis, Indiana  46202
Cleveland Clinic, The Cleveland, Ohio  44195
James Cancer Hospital / Ohio State University Columbus, Ohio  43210
Oregon Health and Science University / Center for Hematologic Malignancies Portland, Oregon  97239-3098
Temple Bone Marrow Transplant Program Philadelphia, Pennsylvania  19111
Virginia Commonwealth University Medical Center Richmond, Virginia  23298