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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
Open (Enrolling)
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

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

- Known cerebral/meningeal disease.

Type of Study:


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:


Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




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



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