acute myeloid leukemia
Conditions
Interventions
After induction induction up to 2 courses (DNR + Ara-C), 3 courses of consolidation therapy ((1) MIT + Ara-C (2) DNR + Ara-C (3) ACR + Ara-C))
Sponsors
Kiyoi Hitoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Newly diagnosed as acute myeloid leukemia (2) Ages, 65-74 (3) ECOG performance status score 0-2 (4) Having sufficient function of liver, kidney, lung and heart (5) Expected to be alive for more than 3 months at the enrollment (6) Having ability to concent in written forms following sufficient explanation regarding this study (7) Asian
Exclusion criteria
Exclusion criteria: (1) Having treatment history of myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement or myelosysplastic/myeloproliferative neoplasms (2) Therapy-related myeloid neoplasms other than AML (3) APL with PML-RARA, myeloid sarcoma or myeloid proliferations associated with Down syndrome (4) Hypoplastic leukemia (less than 20% hypocellularity in bone marrow biopsy along with the absence of fibrotic tissue or other hematological tumors) (5) Having treatment history for preceding bone marrow failure employing cytotoxic or DNA hypomethylating agents (6) Having 20-30% bone marrow blasts, not included in "AML with recurrent genetic abnormality" of the WHO classification, included in "myelodyplastic syndromes" in FAB classification, having dysplastic features and preceeding dyshemopoesis, and having no indication for cytotoxic treatment (7) Having other active cancer (8) Having history of myocardial infarction within a year (9) Having uncontrolable diabetes mellitus (10) Having severe infectious disease (11) Having liver cirrhosis (12) Having deep thrombosis to be treated (13) Having necessity of admission or frequent treatment modification for mental disoreders (14) Positivity of HBs antigen or HIV antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year event-free survival on all eligible cases | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 year EFS on all eligible cases 2 or 5 year EFS on each subcategory of FAB/WHO classification 2 or 5 year overall survival (OS) on all eligible cases 2 or 5 year OS on each subcategory of FAB/WHO classification 2 or 5 year relapse-free survival (RFS) on all eligible cases for consolidation therapies 2 or 5 year RFS on each subcategory of FAB/WHO classification Complete remission (CR) rate on all eligible cases and each subcategory of FAB/WHO classification RFS, OS, EFS and CR rate on each molecular subcategory Cytogenetic response rate on all eligible rate Adverse event rate on all eligible category Treatment performing rate on all eligible cases Quality of life (QOL) on all eligible cases Treatment response rate, prognosis and complication rate on each subcategory obtained from comprehensive geriatric assessment or questionnaire on QOL | — |
Contacts
Public ContactYoshikazu Ito
Tokyo Medical University Hospital
Outcome results
None listed