An observational study in Acute Myeloid Leukemia, Elderly and Intensive Chemotherapy Unfit, sponsored by Ulsan University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2016-03-07.
Sponsored by Ulsan University Hospital · Observational
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)
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 136 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →Ulsan University Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
elderly patients with previously untreated AML who are ufit to receive and not considered candidates for iIC at the time of enrollment
i) ≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC
Exclusion Criteria:
Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.
Drug: Decitabine
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)
Plan to share: No
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Ulsan University Hospital