HOVON 139 CLL: A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial).

Chronic lymphocytic leukemia

MRD negative bone marrow after maximum 24 cycles of (planned) venetoclax and no progression according to IWCLL criteria at any earlier timepoint

Efficacy as assessed by additional outcome measures, including overall response, PFS, EFS and OS, MRD in blood, Toxicity of venetoclax after pre-induction, especially tumorlysis and neutropenia, Quality of life, Geriatric assessment, P16 expression in skin biopsy, Predictive factors for response and resistance mechanisms: NGS at baseline and at progression, Predictive factors for response and resistance mechanisms: Flow-based subset analysis on expression levels of Bcl-2 proteins at baseline, during therapy and at progression, Predictive factors for response and resistance mechanisms: Analyses of malignant and non-malignant immune cells in PB and in LN at baseline and during treatment, Relationship between MRD dynamics and T cell diversity and/or function (amendment December 2021)

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