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

Status: Complete

Description

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.

Eligibility Criteria

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.

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Seattle Genetics

Principal Investigator
unknown unknown

Trial IDs

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