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

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.


Sandra Horning
Michael Link

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Peds Hem/Onc CRAs