Procedures and outcomes
death, infections
MALIGNANCIES, DISEASE PROGRESSION, EVENT, INFECTIONS
Patients were randomly assigned 1:1 to either six 28-day cycles of Ven-Obi, followed by single-agent venetoclax once daily for six cycles, or six cycles of Clb-Obi, followed by single-agent chlorambucil on day 1 and 15 for six cycles. Randomization procedure, dosing schedules and prophylactic measures have been previously publishedBaseline assessments prior to study enrolment included immunophenotyping of circulating lymphocytes by flow cytometry, central analysis of genomic aberrations by FISH, sequencing of the IGHV and The primary endpoint was PFS, with disease progression or death from any cause constituting a PFS event, according to the iwCLL guidelines as determined by the study investigators. Secondary endpoints included MRD rates (measured by ASO-PCR, flow cytometry and NGS) in peripheral blood and bone marrow, TTNT and OS. The exploratory analyses included the relationship between various pre- and post-treatment markers and clinical outcome parameters (including cytogenetic aberrations, IGHV status, transcriptional profiles and MRD; particularly landmark analyses according to MRD status and analysis of time to MRD conversion).AEs were reported until 28 days after the last dose of study treatment. Grade 3 or 4 AEs were to be reported for up to 6 months after last dose of study drug or until initiation of new anti-leukemic therpay. Grade ≥3 infections were reported for 2 years after last dose of study treatment, unless the patient received another line of anti-leukemic therapy after disease progression. After disease progression, only study treatment-related serious AEs and second primary malignancies were required to be reported by the investigator per protocol (Supplementary Table 