OPTIM DASATINIB

Official Title

A prospective randomized phase II study evaluating the optimization of the residual plasmatic level of dasatinib (Sprycel®) in patients newly diagnosed with chronic phase chronic myelogenous leukaemia (CP-CML).

Summary:

See Trial Description.

Trial Description

• To reduce the rate of AEs observed in de novo CP-CML patients treated with dasatinib 100 mg QD.
• To compare the rate of treatment interruptions
• To compare the cumulative duration of dasatinib interruption
• To compare the median dose of dasatinib administered during the first 12 months
• To compare the mean dose of dasatinib administered during the first 12 months
• To compare the cumulative rate of complete cytogenetic response (CCR) at 6, 12 and 18 months, and every 12 months thereafter
• To compare the cumulative rate of major molecular response (MMR) at 3, 6, 12, and 18 months, and every 6 months thereafter
• To compare the cumulative rate of complete molecular response at 3, 6, 12 and 18 months, and every 6 months thereafter 
• To compare the time to molecular response (major or complete) 
• To analyse the relationship between peak plasmatic level (Cmax) and efficacy in the three arms 
• To analyse the relationship between through plasmatic level (Cmin) and efficacy in the three arms
• To compare the progression-free survival (PFS) at 5 years in the three arms
• To compare the event-free survival (EFS) at 5 years in the three arms
• To compare the overall survival at 5 years in the three arms
• To analyse lymphocyte populations before and during dasatinib therapy