Acute promyelocytic leukemia Acute promyelocytic leukemia
Conditions
Interventions
Induction therapy: low-risk group
ATRA 45mg / m2 2-3x po day1-max day 60
After detection of ATO 0.15mg / kg div PML / RARA fusion gene-max day60
Regulate white blood cell count during treatment wit
Sponsors
Takase Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Acute promyelocytic leukemia (APL) cases morphologically diagnosed as AML M3 or AML M3 variant. 2) Initial treatment cases not receiving chemotherapy and radiation therapy. 3) Cases aged between 15 and 75 years old at the time of obtaining consent. 4) Perfomance status (ECOG): 0 to 2 cases. 5) Cases that are expected to survive for 3 months or longer. 6) Cases without serious organ damage. 7) Cases in which written consent has been obtained from the patient after explaining the content of this study. However, in the case of minors, cases in which written consent has been obtained from the substitute and the person.
Exclusion criteria
Exclusion criteria: 1) Cases with active double cancer. 2) Cases with infectious diseases that are difficult to control. 3) Cases with severe mental disorders. 4) Cases of pregnancy or ongoing lactation. 5) In addition, cases that the doctor in charge judged to be inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival 2 years after the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Complete remission rate 2 years after the start of treatment 2) Protocol completion rate 3) Rate of adverse events 4) Differentiation syndrome incidence rate 5) Frequency of additional administration of Idarubicin 6) PML / RARA fusion gene subtypes and therapeutic responsiveness due to gene mutations 7) Analysis of gene expression, protein expression, etc. related to treatment resistance in APL cells | — |
Contacts
Public ContactKen Takase
National Hospital Organization Kyushu Medical Center
Outcome results
None listed