A patient guided dose reduction strategy of tyrosine kinase inhibitors in chronic myeloid leukaemia: a prospective, multi-centre, non-randomised non-inferiority study. - RODEO

Radboud univeristy medical centre0 个研究点目标入组 106 人开始时间: 2022年2月21日最近更新: 2022年5月16日

适应症

试验速览

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•All adult CML patients (aged = 18 years) in chronic phase, who are treated with a TKI (imatinib, bosutinib, dasatinib, nilotinib, ponatinib), who have reached optimal treatment response i.e. at least major molecular response (MMR or MR3) are eligible for participation. MMR is defined as two consecutive BCR-ABL levels <0,1% for at least 6 months. There are no restrictions regarding using a lower than standard dose, or previously having switched from TKI.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•Patients with molecular or cytogenetic failure to previous TKI or who have undergone previous allogeneic hematopoietic stem cell transplantation will be excluded. Furthermore, patients who are in accelerated phase or blast crisis or using a TKI directed by known kinase-domain mutations will be excluded as well. Other exclusion criteria are pregnancy, lactation or a life expectancy of less than a year.

发起方

Radboud univeristy medical centre