Acute promyelocytic leukemia
Conditions
Interventions
ALL eligible patients receive 2 courses of induction therapy comprising ATRA, cytarabine and anthracyclines. Patients who achieved hematological CR (standard risk group) receive 3 courses of consoli
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 methods; karyotyping, FISH, or RT-PCR. ECOG performance status score of 0-2, or of 3 when caused by leukemia. No previous treatment. Written informed consent obtained either from patient or guardians.
Exclusion criteria
Exclusion criteria: 17q12/RARA not detected genetically and cytogenetically APL with t(11;17)(q23;q12)/PLZF-RARA CNS hemorrhage which is likely to interfere protocol therapy Secondary APL due to previous chemotherapy or radiation therapy Unmanageable infectious disease including tuberculosis 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 Molecular remission rate at the end of consolidation therapy Three-year overall survival rate Rate of DIC, APL-DS, and mortality during first remission induction therapy Rate of adverse events during ATO therapy Rate of adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Takahashi
Toho University Department of Pediatrics
Outcome results
None listed