Acute promyelocytic leukemia
Conditions
Interventions
Five courses of multi-agent combination chemotherapy (2 courses for remission induction and 3 for intensification) consisted of ATRA, anthracyclines, and cytarabine, followed by single-agent maintenan
Sponsors
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with a diagnosis of APL Genetically or cytogenetically diagnosed by either one of three examination; chromosome, FISH, or southern blot Age less than 18 years old ECOG performance status score of 0-2, or of 3 when caused by leukemia No previous treatment Sufficient hepatic, renal, and cardiac function Possible clinical observation for more than 3 years Written informed consent obtained from guardians
Exclusion criteria
Exclusion criteria: CNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis Pregnancy Septic shock History of organ transplantation History of congenital or acquired immunodeficiency Any inappropriate status judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year event-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission induction rate Three-year overall survival rate Rate of adverse events Rate of DIC or retinoic acid syndrome in the first remission induction therapy Rate of mortality in the first remission induction therapy Three-year CNS relapse rate | — |
Countries
Japan
Contacts
Public ContactTetsuya Takimoto
JPLSG Deta Center
Outcome results
None listed