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A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)


Phase 2
12 Years
N/A
Open (Enrolling)
Both
Disease, Hodgkin

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Trial Information

A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)


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-avid disease by positron emission tomography and measurable
disease of at least 1.5 cm as documented by spiral computed tomography.

- 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 brentuximab vedotin.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate by Independent Review Group

Outcome Description:

Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG035-0003

NCT ID:

NCT00848926

Start Date:

February 2009

Completion Date:

August 2015

Related Keywords:

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

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Stanford University Medical Center Stanford, California  94305-5408
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Medical Center Rochester, New York  14642
Rocky Mountain Cancer Center Denver, Colorado  80218
City of Hope National Medical Center Los Angeles, California  91010
University of Washington Seattle, Washington  98195
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Oregon Health & Science University Portland, Oregon  97201
Georgetown University Washington, District of Columbia  20007-2197
Ohio State University Columbus, Ohio  43210
University of Texas MD Anderson Cancer Center Houston, Texas  77030
University of Miami Miami, Florida  33136
Karmanos Cancer Institute Detroit, Michigan  48201
Mayo Clinic Rochester Rochester, Minnesota  55905
University of California at Los Angeles Los Angeles, California  90095
Weill Cornell Medical College New York, New York  10021
Baylor Sammons Cancer Center Dallas, Texas  75246
Loyola University Medical Center Cardinal Bernardin Cancer Center Maywood, Illinois  60153