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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin

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.