©2024 Stanford Medicine
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
Purpose
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)
Eligibility
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.
Intervention(s):
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
6507362563