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

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

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.