NCT00436280

Chemotherapy for Participants With Lymphoma

An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to help answer the following research questions: * To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) remain free from disease and thus live longer. * To assess for any side effects that might be associated with enzastaurin and R-GEMOX . * To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body. * To look at the level of enzastaurin in the body and how long it remains.

Conditions

• Lymphoma, Large Cell, Diffuse

Interventions

Type	Name	Description
DRUG	enzastaurin	1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
DRUG	gemcitabine	1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
DRUG	rituximab	375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
DRUG	oxaliplatin	100 mg/m², IV, once every two weeks, four to eight 2 week cycles

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2012-11-01
• First posted: 2007-02-19
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

18 sites across 3 countries: France, Germany, Russia