Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

Study Overview
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Brief Summary
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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)

Official Title
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Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice

Conditions
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Acute Myeloid Leukemia, Elderly, Intensive Chemotherapy Unfit

Intervention / Treatment
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* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%) 65 years of age or older Taking informed consent with signature and date 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) investigator's judgement incompatible with iIC Exclusion Criteria: Candidate for iIC at the time of enrollment Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement AML with t(9;22) or BCR/ABL rearrangement Leukemia central nervous system involvement Extramedullary myeloid sarcoma without bone marrow involvement Prior treatment with decitabine or azacitidine of any cause Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine 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 Premenopausal woman Severe active infection Uncontrolled bleeding Hypersensitivity to decitabine

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Decitabine<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after 4 cycles of decitabine treatment (about 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of composite CR | CR+CRp+ CR with incomplete blood count recovery (CRi) | after 4 cycles of decitabine treatment (about 4 months) | 
| Clinical benefit rate | cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD) | 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. | 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. | 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 | until 4 cycles of decitabine treatment (about 4 months) |