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A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
Trial ID: NCT00529503
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.
A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
- 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
- At least one measureable lesion that is both greater than or equal to 1.5cm by
radiographic imaging and by positive FDG-PET scan.
- 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.
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