Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)
Study Type
OBSERVATIONAL
Enrollment
136
Ulsan University Hospital
Ulsan, South Korea
The rate of complete remission
The rate of complete remission and complete remission with incomplete platelet recovery (CRp) will be measured by 4 cycles of decitabine treatment.
Time frame: after 4 cycles of decitabine treatment (about 4 months)
The rate of composite CR
CR+CRp+ CR with incomplete blood count recovery (CRi)
Time frame: after 4 cycles of decitabine treatment (about 4 months)
Clinical benefit rate
cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)
Time frame: after 4 cycles of decitabine treatment (about 4 months)
Change of quality of life scale using EQ-5D-3L
Quality of life measurement by EQ-5D will be compared between pre- and post-decitabine therapy.
Time frame: after 4 cycles of decitabine treatment (about 4 months)
Change of quality of life scale using EORTC QLQ-C30
Quality of life measurement by EORTC QLQ-C30 will be compared between pre- and post-decitabine therapy.
Time frame: after 4 cycles of decitabine treatment (about 4 months)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
CTCAE version 4.03
Time frame: until 4 cycles of decitabine treatment (about 4 months)
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