Overview

Chemotherapy for Participants With Lymphoma

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Gemcitabine
Oxaliplatin
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