Title: Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Description: In a phase 3 multinational, randomized, double-blind trial, researchers are seeking to compare the efficacy and safety of the combination of ibrutinib and venetoclax compared with ibrutinib and placebo in patients with mantle cell lymphoma.
Primary outcomes of the trial include occurrence of tumor lysis syndrome, occurrence of dose-limiting toxicities, progression-free survival, and complete response.
In order to enroll, patients must have pathologically confirmed MCL with documentation of either overexpression of cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization, or polymerase chain reaction. Patients must also have at least 1 measurable site of disease on cross-sectional imaging (CT/PET) and at least 1 but no more than 5 prior therapies. To review the complete inclusion and exclusion criteria please refer to the reference.
This study is sponsored by Pharmacyclics LLC.
Clinicaltrials.gov. Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO). NCT03112174. Accessed April 23, 2021.