Overview
Chemotherapy for Participants With Lymphoma
Status:
Completed
Completed
Trial end date:
2012-11-01
2012-11-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eli Lilly and CompanyTreatments:
GemcitabineOxaliplatin
Rituximab
Criteria
Inclusion Criteria:- Diagnosis of DLBCL or transformed (cluster differentiation 20 [CD20]+) indolent
lymphoma
- Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or
participants who have not progressed after stable disease (SD) obtained in 1st- or
2nd-line.
- Measurable disease (lymph node greater than 1.5 cm)
- Adequate organ function
- Greater than or equal to 60 years or less than 60 (but greater than or equal to 18
years) who are not eligible for high-dose chemotherapy high-dose chemotherapy (HDC)
and autologous stem cell transplant (ASCT)
Exclusion Criteria:
- Prior Allogeneic transplantation
- More than 2 prior anticancer treatment regimens
- Pregnant or breastfeeding
- Human-immunodeficiency-virus (HIV)associated lymphomas
- Brain metastases