Asciminib as single agent or in combination with nilotinib in the 1st-line treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a GIMEMA-GELMC phase II study. CML1624

BCR-ABL1+ Chronic Myeloid Leukemia

The primary endpoint is the rate of deep molecular response (MR4) at 2 years; patients with not evaluable molecular analysis may repeat a QPCR analysis in 1 month (25 months from day 1)

The rate of sustained MR4 or MR4.5 at 4 years (TFR eligibility) and the proportion of patients free from relapse (BCR::ABL1 transcript < 0.1%) 12 months after treatment discontinuation, The rate of major molecular response (MR3) at and by 1, 2, 3, 6, 12, 18 and 24 months, and the rate of MR4 and MR4.5 at and by 1, 2, 3, 4 years, The median time to response (MR3, MR4, MR4.5) and the relationship between the time to response (response at milestones) and the TFR eligibility at 4 years and the TFR rate 12 months after discontinuation, Outcome measures at 2 and 5 years: overall survival (OS), survival without leukemia-related death, progression-free survival (PFS), Outcome measures at 5 years according to baseline prognostic factors (Sokal and ELTS score, CCA in Ph+ cells, BCR::ABL transcript type, and according to the early response (BCR::ABL transcript level at 3 and 6 months), Incidence and VAF of treatment emergent BCR::ABL1 mutations, Incidence and VAF of BL and treatment emergent cancer related somatic mutations and relationship with treatment efficacy, including treatment-free remission and outcome, Incidence of hematologic and non-hematologic adverse events, Mean HRQoL scores trajectories by the EORTC QLQ-C30 and QLQ-CML24 questionnaires according to treatment arm

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