acute promyelocytic leukemia
Conditions
Interventions
Induction:ATRA 45mg/m2 2-3x po day1-max day74 Consolidation:ATO 0.15mg/kg div day15-max day74
Sponsors
FBMTG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute promyelocytic leukemia by WHO classification 2. The first time treatment example which does not catch chemotherapy or the radiotherapy 3. The case that is equal to or less than 65 years old more than age 15 years old 4. Performance status 0-2 5. A case without the dangerously ill internal organs disorder 6. The case that an agreement by the document is provided from a patient on explanation because of final examination contents
Exclusion criteria
Exclusion criteria: 1. The case having double cancers 2. The case with an infectious disease having difficulty with control 3. The case with a severe mental disorder 4. The pregnancy or breast-feeding woman 5. The case that the medical attendant judged to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 years disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 years disease free survival CR rate Perfection rate of protocol regimen treatment-related toxicities Incidence rate of differentiation syndrome Frequency of additional administration of idarubicune Frequency of mutation in PML-RARA fusion gene and its influence for therapy efficacy | — |
Countries
Japan
Contacts
Public ContactFBMTG Study Office
FBMTG FBMTG Study Office
Outcome results
None listed