acute myeloid leukemia
Conditions
Interventions
Single course of combination chemotherapy consisted of G-CSF, fludarabine, cytosine arabinoside, and idarubicin is performed for all the eligible patients
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. AML (excluding AML with Down syndrome, APL, secondary AML, NK/myeloid leukemia, and granulocytic sarcoma) 2. the first bone marrow relapse (including extramedullary relapse at the same time) or induction failure 3. age less than 18 years old at diagnosis 4. age over than 1 years old and less than 20 years old at enrollment 5. ECOG performance status score :0-3 6. sufficient hepatic, renal and cardiac function satisfying the laboratory data listed below; T. Bil. :less than 3 mg/dl ALT: within 10X of the institutional normal range serum creatinine value: less than 5 years old, less than 0.8mg/dl. 5-10 years old, less than 1.2 mg/dl. 10-20 years old, less than 1.5 mg/dl ECG: no severe abnormalities (example; QTc 0.45 or more sec) UCG: EF 50% or more, FS 25% or more, no finding of cardiac dysfunction 7. written informed consent obtained from guradians
Exclusion criteria
Exclusion criteria: 1. isolated extramedullary relapse 2. history of allogeneic stem cell transplantation 3. history of FLAG therapy 4. any complication listed below; active or unmanageable infectious disease, severe CNS bleeding(example; CTCAE Ver. 4.0; grade 3 or more, uncontrolled DM, severe mental abnormalities, heart diseases, hemophillia, autoimmune diseases 5. pregnancy 6. history of congenital or acquirede immunodeficiency 7. contraindication of cytosine arbinoside or idarubicin 8. administration of anti-cancer agent within 14 days of the enrollment 9. unusual treatment schedule or intermission in the first induction chemotherapy for AML because of personal request etc 10. any inappropriate status judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of bone marrow remission after the treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive rate of MRD by FACS after the treatment regimen Two-year event free survival rate and over all survival rate Rate of remission, two-year event free survival and over all survival between the first bone marrow relapse patients and induction failure patients Rate of remission, two-year event free survival and over all survival among times of relapse and chromosomal abnormalities Rate of adverse events (CTCAE ver.4.0, grade 3 or more) Rate of accomplishment of the protocol Rate of early death | — |
Countries
Japan
Contacts
Public ContactAkiko Saito
National Hospital Organization Nagoya Medical Center Clinical Research Center, Laboratory of Clinical, Epidemiological and Health
Outcome results
None listed