OPTIM DASATINIB

Titre officiel

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).

Sommaire:

Voir la description de l'essai.

Description de l'essai

  • 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

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Société canadienne du cancer

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