Study design and oversight

This study was an investigator-initiated, multicenter, single-arm, prospective phase 2 trial of a combination of ibrutinib and venetoclax in patients with previously untreated WM. The study enrolled patients at the Dana-Farber Cancer Institute (DFCI), Massachusetts General Hospital, and Beth Israel Deaconess Medical Center in Boston, Massachusetts. Enrollment began in July 2020 and was closed in January 2022. The date of data cutoff was 31 May 2023. This study was approved by the DFCI's institutional review board. All the patients provided written informed consent for participation. Pharmacyclics and AbbVie provided the research funding and study drugs. The trial was registered under ClinicalTrials.gov #{"type":"clinical-trial","attrs":{"text":"NCT04273139","term_id":"NCT04273139"}}NCT04273139.