Femme et Homme
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Extrait
The primary objective of the study is to evaluate the efficacy of the GIVe regimen in patients with TP53 deletion (17p-) and/or mutation and previously untreated CLL requiring treatment. For this, the CR rate at cycle 15 (d1; final restaging) will be used as primary parameter for efficacy. The CR rate is defined as the proportion of patients having achieved a CR or a CR with incomplete recovery of the bone marrow (CRi) as best response (according to iwCLL criteria) until cycle 15 (d1; final restaging) from start of therapy. Efficacy of the regimen will be further assessed by evaluation of the proportion of patients free of disease progression (PD-free rate) after 12 cycles of therapy, overall response rate (ORR), minimal residual disease (MRD) and overall survival as well as other time to event endpoints as outlined below.
Critère d'inclusion
- Physically fit and unfit patients with TP53 deletion (17p-) and/or mutation and previously untreated CLL requiring therapy