None listed
Conditions
Interventions
Drug : - Group 1(mLDAC): For 1st chemotherapy cycle, application of cytarabine 20mg/m^2 subcutaneously every 12 hours a day, totally for 14 days. When the patients is severely morbid or in severe infe
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with 65 years or older and unfit for intensive chemotherapy (Satisfying at least 1 condition below) - Poor-risk molecular cytogenetics group - At least 2 conditions among followings (75 years old or older, ECOG (Eastern Cooperative Oncology Group) performance score 2-4, leukocyte counts at diagnosis > 50,000/microL) - HCT-CI (Hematopoietic cell transplantation - comorbidity index) score with 3 or more • Sufficient liver or renal function (= 2.5 x upper normal limit)
Exclusion criteria
Exclusion criteria: • Acute promyelocytic leukemia presenting t(15;17) or PML/RARa • Central nervous system involvement • Myeloid sarcoma without bone marrow involvement • Uncontrolled prior infectious disease • Uncontrolled bleeding • Remnant previous malignancies in another organ • Serious cardiovascular disease within 6 months from screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival and disease free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment response including complete remission and incomplete remission, treatment complication and infectious complications and mortaility rate | — |
Countries
Korea, Republic of
Contacts
Public ContactJae-Ho Yoon
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed