A Multicentre, Open-Label, Randomized, Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator’s Choice of Treatment in Adults (> 18 Years) with Chronic Lymphocytic Leukemia and Moderate to Severe Cardiac Impairment

Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment

Frequency and time to discontinuation of any study treatment due to worsening in cardiovascular. function or cardiovascular Adverse events (AEs)., Incidence of Grade 4 and 5 cardiovascular events of interest., Incidence and relationship to study treatment of: - Grade ≥ 3 AEs. - Serious adverse events (SAEs). - Adverse events of special interest (AESI) defined per acalabrutinib Invetigator’s Brochure (IB). - Non-cardiovascular AE that lead to discontinuation of any study treatment. - Events of clinical interest (ECI)as defined in the Statistical Analysis Plan (SAP).

Overall survival (OS), defined as the time from randomisation to death from any cause., Per iwCLL 2018 criteria (Hallek et al, 2018): Event-free survival (EFS), defined as the time from randomisation to disease progression, initiation of subsequent anti-CLL therapy, or death from any cause, whichever occurs first., Overall response rate (ORR), defined as the proportion of patients with a complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR)., Duration of response (DOR), defined as the time from the first documented response (PR or better) to disease progression or death (by any cause in the absence of disease progression)., Progression‑free survival (PFS), defined as the time from randomisation to disease progression or death (by any cause in the absence of disease progression).

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