Acute myeloid Leukemia Myelodysplastic syndrome
Conditions
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group(JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)AML(excluding APL) and MDS with Down syndrome 2)age more than 4 month and less than 18 years old 3)ECOG performance status score of 0-3 4)no history of previous chemotherapy (except administration of cytarabine for transient myeloproliferative disorder) or radiotherapy 5)sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below: T-Bil: within 3 times of the age-dependent normal range serum creatinine value: within 3 times of the age-dependent normal range ECG: no severe abnormalities (example; QTc >0.45) 6)written informed consent obtained from guardians
Exclusion criteria
Exclusion criteria: 1)CNS hemorrhage which is likely to intervent protocol therapy 2)uncontrolled DM 3)uncontrolled cardiac failure 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)CNS leukemia 8)any inappropriate status judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two-year event-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission rate after initial induction chemotherapy Remission rate for high risk group Three-year overall survival rate Two-year event free survival for each risk group Three-year overall survival for each risk group Incidence of FLT3-ITD Two-year event free survival with or without FLT3-ITD Incidence of adverse events during chemotherapy Compliance rate of protocol specified regimen Three-year event free survival of the patients less than 4 years old | — |
Countries
Japan
Contacts
Public ContactTakashi Taga
Shiga University of Medical Science Departiment of Pediatrics
Outcome results
None listed