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

Not Recruiting

Trial ID: NCT00866047


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)

Stanford Investigator(s)


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)

   - 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.


drug: brentuximab vedotin

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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