Full TitleA Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
R-CHOP (a combination of the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is the standard chemotherapy regimen for patients with DLBCL. However, many patients do not respond adequately to this treatment or experience a return of the cancer after responding to therapy, especially those with a subset of DLBCL called non-germinal center B-cell lymphoma.
In this study, researchers want to determine if adding the drug ibrutinib (PCI-32765) to R-CHOP therapy is more effective than R-CHOP alone in patients with non-germinal center DLBCL who are newly diagnosed and have not been previously treated. Ibrutinib works by blocking a protein inside the lymphoma cells called Bruton’s tyrosine kinase (BTK), which helps the lymphoma cells to live and grow. It has been shown to be effective in patients with non-germinal center DLBCL, but it is not known if adding it to R-CHOP therapy is better than R-CHOP alone in untreated patients.
Patients in this study will be randomly assigned to receive R-CHOP with ibrutinib or R-CHOP with a placebo (sugar pill). Ibrutinib is a capsule that is taken orally (by mouth), while R-CHOP is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have stage II, III, or IV non-germinal center diffuse large B-cell lymphoma that has not been previously treated.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 and older.