IRB Number:

06-002988

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study will compare patients who are using the investigational drug enzastaurin every day, to patients who are following the current standard of care. This will help us:

- Find out what effects (good and bad) the enzastaurin (a drug) has on the patient and their cancer
- Determine if there are indicators (markers) in a patient's blood or tissue that might tell us if an individual would respond better to this drug than others
- Find out how enzastaurin is used by the body, how long it stays in the body, and how the body gets rid of it
- Find out what effect this drug has on a patient's over all quality of life. We will do this by having patients complete questionnaires at some of their study visits.

Who is Eligible to Participate in the Study?

-Diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL) and have completed first-line treatment for the cancer.

More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

-Medical history and physical exams
-Blood tests
-Pregnancy test, if woman of childbearing potential
-CT(s) or MRI(s)
-Completion of questionnaires
-Medication given in pill form

How long will the Study run?

Patients will be in the study for up to three years. If patient's lymphoma returns, they will stop the study.

Sponsor(s): Eli Lilly and Company, Mayo Clinic Cancer Research Consortium (MCCRC)

Study Activation/Registration Date: 08/17/2007

IRB Review and Approval Date: 01/10/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 459 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Thomas Habermann, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 07/10/2009