NCT00529503

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	SGN-40	2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.
DRUG	placebo	Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.
DRUG	rituximab	375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1
DRUG	etoposide	100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.
DRUG	carboplatin	AUC=5 mg/mL min IV. Cycles 1-3: Day 2.
DRUG	ifosfamide	5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-12-01
• Completion: 2011-05-01
• First posted: 2007-09-14
• Last updated: 2015-02-25

Locations

66 sites across 10 countries: United States, Australia, Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Spain