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

Not Recruiting

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.

Official Title

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)

Stanford Investigator(s)


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.


drug: SGN-40

drug: placebo

drug: rituximab

drug: etoposide

drug: carboplatin

drug: ifosfamide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury

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