A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma
What is the purpose of this trial?
Primary Objective The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab will result in prolongation of progression-free survival (PFS) in subjects with newly diagnosed MCL who are 65 years of age or older. Secondary Objectives Secondary objectives include evaluation of overall survival; CR rate; overall response rate (CR+ partial response [PR]); patient-reported lymphoma symptoms and concerns as measured by the lymphoma (Lym) subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym); minimal residual disease (MRD) negative rate; duration of response; time-to-next treatment (TTNT); safety of ibrutinib when combined with BR; and to characterize the pharmacokinetics of ibrutinib and explore the potential relationships between ibrutinib metrics of exposure with relevant clinical, pharmacodynamic, or biomarker information. Exploratory Objectives Exploratory objectives are to evaluate patient-reported outcomes (PRO) related to well-being and general health status utilizing the FACT-Lym and EuroQol (EQ-5D-5L); and to explore biomarkers identified from other studies of ibrutinib in samples collected for MRD assessments.
- 65 Years - N/A
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- Janssen Pharmaceuticals
- Last Updated:
- Study HIC#: