10-day decitabine, fludarabine and 2 Gray TBI as conditioning strategy for poor and very poor risk AML in CR1 - Decitabine in the conditioning strategy for AML. PLMA34 study

Radboud university medical center0 个研究点目标入组 45 人开始时间: 2014年6月20日最近更新: 2020年9月7日

适应症

试验速览

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•Inclusion criteria
•Patients eligible for allogeneic HCT, independent of age
•Patients of any age with a cytopathologically confirmed diagnosis according to WHO classification of newly diagnosed AML (not APL = AML-M3), de novo AML or secondary AML
•in first complete remission (CR1)
•Poor risk or very poor risk subgroups
•WHO performance status = 2
•Written informed consent
•Poor risk is defined as: - Normal karyotype, WBC = 100, not in CR after first cycle of chemo
•- Normal karyotype, WBC > 100
•- Abnormal karyotype, non CBF, MK, no abn 3q26, EVI1-
•Very poor risk is defined as:- Non CBF, MK+
•- Non CBF, abn eq26
•- Non CBF, EVI1+
•- Non CBF, high Flt3-ITD allelic burden
•CBF = Core Binding Factor
•MK = monosomal karyotype
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Exclusion criteria
•Patient not in CR1
•Patients who have senile dementia, mental impairment of any other psychiatric disorder that prohibits the patient from understanding and giving informed consent
•Active serious infections like HIV, HBV and HCV
•Patient is unwilling to use contraceptive techniques during and for 12 months following treatment
•Female patient who is pregnant or breastfeeding

发起方