Outcomes
death, Cancer
ADVERSE EVENT, CLL, RECRUITMENT, ADVERSE EVENT, CANCER
Per protocol, the primary end point was the ORR at the interim staging after end of induction therapy (after six cycles), for patients who received at least two cycles of study treatment, including at least one administered dose in cycle three, who comprised the full analysis set (FAS; see below). Response was assessed according to the refined Lugano criteria based on positron emission tomography–computed tomography or, if not available, based on computed tomography scansPost hoc exploratory analyses included the assessment of ORR after six cycles and time-to-event analyses for all enrolled patients of the ITT population, the assessment of a modified TTNT (defined as the time from enrollment until initiation of next treatment for CLL/RT or death from any cause), univariate analyses of potential prognostic factors for ORR after six cycles, overall survival, PFS, DOR and the assessment of ORR and PFS, comparing of the RT and BTK-naive patients to previously treated patients.Adverse events were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events v.5.0. An interim safety analysis was conducted by the principal investigator, coordinating physician, statistician and safety management team of the German CLL Study Group (GCLLSG), after the first six patients had been treated for three cycles. Recruitment was only continued if no safety concerns were raised by the interim safety review.