This study is comparing the effectiveness of R-CHOP chemotherapy with or without enzastaurin (Kinenza) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The main outcome to be measured will be overall survival at the end of the study.
The current standard first-line treatment for DLBCL is R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy. However, about 30 – 40% of patients fail to achieve a complete response (disappearance of all signs of cancer). Improving this rate can help improve outcomes for these patients.
This study is comparing R-CHOP plus enzastaurin versus R-CHOP alone in patients with previously untreated DLBCL. Enzastaurin blocks cancer cell growth. This leads to cancer cell death. The main outcome will be measured is overall survival (the number of patients still alive) at 3.5 years after treatment.
Who are they looking for?
This study is recruiting 235 patients with previously untreated DLBCL. Patients should be willing to use contraception during the study, and for 3 months after finishing the study treatment. Patients should agree to have blood samples stored for future potential analysis. Patients who have been disease-free from a secondary cancer for more than 5 years are also eligible.
Patients should not have any active infections, secondary cancers, brain metastases, or heart disease. Patients should not have a history of severe allergic reactions to monoclonal antibody therapy. Patients should not receive a live vaccine at least 28 days before starting study treatment.
How will it work
During the induction phase of the study, patients will be divided into two groups. The first group will receive R-CHOP plus enzastaurin. The second group will receive R-CHOP plus placebo (a substance with no active effect). During the maintenance phase of the study, patients in the enzastaurin group who responded to treatment will receive enzastaurin monotherapy for up to 2 years. All patients will be followed-up for 3.5 years.
Effectiveness will be measured as overall survival at follow-up. Safety will also be measured as the number of patients who experience side effects at follow-up.