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

Trial Status: Complete

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

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-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
  • Received any previous autologous stem cell transplant 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 brentuximab vedotin.
  • 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.

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: COMPLETED

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

New York

New York
Memorial Sloan Kettering Cancer Center
Status: COMPLETED

Ohio

Columbus
Nationwide Children's Hospital
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: COMPLETED

Tennessee

Memphis
St. Jude Children's Research Hospital
Status: COMPLETED

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Seattle Genetics

Principal Investigator
unknown unknown

  • Primary ID SG035-0004
  • Secondary IDs NCI-2009-00983, 2008-006035-12
  • Clinicaltrials.gov ID NCT00866047