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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 CenterNew York, New York  10021
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Medical CenterRochester, New York  14642
Hackensack University Medical CenterHackensack, New Jersey  07601
City of Hope National Medical CenterLos Angeles, California  91010
Baylor University Medical CenterDallas, Texas  75246
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Stanford Cancer CenterStanford, California  94305-5824
University of MinnesotaMinneapolis, Minnesota  55455
Northwestern UniversityChicago, Illinois  60611
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Johns Hopkins Medical CenterBaltimore, Maryland  
Cancer Center of the CarolinasGreenville, South Carolina  29615
University of California at San FranciscoSan Francisco, California  94115
Northside HospitalAtlanta, Georgia  30342
Saint Francis HospitalGreenville, South Carolina  29601
New York University Cancer InstituteNew York, New York  10016
Colorado Blood Cancer InstituteDenver, Colorado  80218
Karmanos Cancer Institute / Wayne State UniversityDetroit, Michigan  48201
MD Anderson Cancer Center / University of TexasHouston, Texas  77030-4003
Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywood, Illinois  60153
UNC Lineberger Comprehensive Cancer Center / University of North CarolinaChapel Hill, North Carolina  27599
University of Chicago Section of Hematology/Oncology Lymphoma ProgramChicago, Illinois  60637-1470
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380Indianapolis, Indiana  46202
Cleveland Clinic, TheCleveland, Ohio  44195
James Cancer Hospital / Ohio State UniversityColumbus, Ohio  43210
Oregon Health and Science University / Center for Hematologic MalignanciesPortland, Oregon  97239-3098
Temple Bone Marrow Transplant ProgramPhiladelphia, Pennsylvania  19111
Virginia Commonwealth University Medical CenterRichmond, Virginia  23298