A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

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

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Genentech, Inc.
• Treatments: Carboplatin; Dacetuzumab; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Rituximab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.

• Received at least four cycles of first-line therapy with R-CHOP, or equivalent.

• Best clinical response to first-line therapy of stable disease, partial response, or complete response.

• At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan.

Exclusion Criteria:

• Leptomeningeal or central nervous system lymphoma.

• Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.

• Received a hematopoietic stem cell transplant.