NCT00655837

Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL

A Phase Ib Study of SGN-40 in Combination With Rituximab and Gemcitabine for the Treatment of Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety and tolerability of combination therapy of SGN-40 with gemcitabine and rituximab for the treatment of lymphoma. This study is also intended to estimate how well your disease responds to this treatment.

Conditions

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

Interventions

Type	Name	Description
DRUG	SGN-40	4-12mg/kg IV; Days 1, 4, 8, 15 and 22 of Cycle 1 and Days 1, 8 and 15 of Cycles 2-8.
DRUG	rituximab	375 mg/m2 IV injection; Days -2, 8, 15 and 22 of Cycle 1 and Day 1 of Cycles 2-8.
DRUG	gemcitabine	1000 mg/m2 IV Injection; Days 1 and 15 of all Cycles.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-04-10
• Last updated: 2014-12-18

Locations

9 sites across 1 country: United States