Study design and patients
DISEASE PROGRESSION, DISEASE
M20-075 is an open-label, single-arm, Phase 2 study (NCT04477486). There were 12 sites that participated in the study, of which eight sites enrolled patients. The full eligibility criteria are described in the Supplementary Materials. Briefly, patients aged 20 years or older with pathologically confirmed MCL with at least one measurable disease were enrolled. Patients must have been previously treated with one to five prior lines of therapy including at least one prior rituximab/anti-CD20–containing regimen. Failure to achieve at least a partial response (PR) with, or documented disease progression after, the most recent treatment regimen was required. No prior therapy with ibrutinib or other BTKis was allowed. The full analysis set (FAS) comprised patients who received ≥ 1 dose of study drug. The per protocol set (PPS) excluded FAS patients who were determined to have non-evaluable disease at baseline based on assessment by independent review committee (IRC). The study was approved by institutional review boards and/or independent ethics committees. The study was conducted in accordance with the International Council for Harmonisation guidelines and the Declaration of Helsinki. All patients provided written consent.