At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating enzastaurin, gemcitabine, and 2 other interventions for Lymphoma, Large Cell, Diffuse. Completed, enrolled 68 participants across 18 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
100 mg/m², IV, once every two weeks, four to eight 2 week cycles