Title: Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)
Description: In a phase 3 trial, researchers are comparing combination ibrutinib and venetoclax with ibrutinib alone in patients with relapsed/refractory or treatment-naïve mantle cell lymphoma (MCL).
Participants are randomly assigned to receive ibrutinib plus venetoclax or ibrutinib plus placebo until disease progression or unacceptable toxicity. The study has a safety run-in period and a randomization period.
The primary outcome measures include the occurrence of tumor lysis syndrome, dose-limiting toxicities, adverse events, overall response rate, duration of response, progression-free survival (PFS), and overall survival in the safety run-in period, as well as PFS during the randomization period and complete response rate in the treatment-naïve arm.
To be eligible for this study, patients must have pathologically confirmed MCL with documentation of either cyclin D1 overexpression in association with other relevant markers or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization, or polymerase chain reaction. For a complete list of eligibility criteria, please refer to the reference.
Status: Active, not recruiting
This study is sponsored by Pharmacyclics LLC, in collaboration with Janssen Research & Development, LLC.
Clinicaltrials.gov. Study of ibrutinib combined with venetoclax in subjects with mantle cell lymphoma (SYMPATICO). NCT03112174. Accessed November 15, 2021.