Clinical trial NCT02698124: Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myeloid Leukemia
Elderly
Intensive Chemotherapy Unfit
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Society of Hematology, AML/MDS Working Party
First posted: 2016-03-03
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients with previously untreated AML who are ufit to receive and not considered candidates for iIC at the time of enrollment

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
2. 65 years of age or older
3. Taking informed consent with signature and date
4. 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:

1. Candidate for iIC at the time of enrollment
2. Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement
3. AML with t(9;22) or BCR/ABL rearrangement
4. Leukemia central nervous system involvement
5. Extramedullary myeloid sarcoma without bone marrow involvement
6. Prior treatment with decitabine or azacitidine of any cause
7. Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine
8. 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
9. Premenopausal woman
10. Severe active infection
11. Uncontrolled bleeding Hypersensitivity to decitabine

Primary outcomes:
measure: The rate of complete remission
timeFrame: after 4 cycles of decitabine treatment (about 4 months)
Secondary outcomes:
measure: The rate of composite CR
timeFrame: after 4 cycles of decitabine treatment (about 4 months)
measure: Clinical benefit rate
timeFrame: after 4 cycles of decitabine treatment (about 4 months)
measure: Change of quality of life scale using EQ-5D-3L
timeFrame: after 4 cycles of decitabine treatment (about 4 months)
measure: Change of quality of life scale using EORTC QLQ-C30
timeFrame: after 4 cycles of decitabine treatment (about 4 months)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: until 4 cycles of decitabine treatment (about 4 months)
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
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