None listed
Conditions
Interventions
None listed
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria a) Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts =20%) b) 65 years of age or older c) Taking informed consent with signature and date d) Not eligible for iIC based on either: 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) vii) investigator’s judgment incompatible with iIC
Exclusion criteria
Exclusion criteria: Exclusion criteria a) Candidate for iIC at the time of enrollment b) Promyelocytic leukemia, or AML with t(15;17) or PML/RARa rearrangement c) AML with t(9;22) or BCR/ABL rearrangement d) Leukemia central nervous system involvement e) Extramedullary myeloid sarcoma without bone marrow involvement f) Prior treatment with decitabine or azacitidine of any cause g) Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine h) Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer i) Premenopausal woman j) Severe active infection k) Uncontrolled bleeding l) Hypersensitivity to decitabine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy assessments:Peripheral blood (PB) will be assessed at baseline and on Day 1 of each cycle for response evaluation. It is recommended that Bone marrow (BM) aspirate/biopsy will be performed at screening and then at the end of cycles 4 unless PB shows persistence of leukemic blasts that excludes the possibility of a marrow response. After cycle 4 BM assessment, it is recommended that BM aspirate/biopsy will be repeated every 4 months for the first year on study and then every 6 months thereafter until PB or BM assessment shows disease progression or relapse. Response evaluation will be based on BM assessment and the most concomitant PB counts.;Safety assessments: Documented safety assessments will include AEs, concomitant medications, physical examination results, vital signs, ECOG performance status, hematology and chemistry according to the schedule of events. Report of SAE will be done according to IRB SOP. Other safety assessemt will be a part of usual practice at the investigator’s discretion. | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-3L (Korean version) and QLQ-C30 (Korean version) will be administered before treatment on screening and cycle 5 (or end of cycle 4), or at the end of study when treatment is early terminated before cycle 4);Blood and BM samples will be collected at screening for biomarker study (microRNA, TET2 activation and whole genome sequencing). | — |
Countries
Korea, Republic of
Contacts
Public ContactJonghee Han
Gachon University Gil Medical Center
Outcome results
None listed