AML-P13
- Conditions
- Acute promyelocytic leukemia
- Registration Number
- JPRN-jRCTs051180191
- Lead Sponsor
- TAKAHASHI Hiroyuki
- Brief Summary
Three-year EFS rate in the JPLSG AML-P13 study was 96.3%. Molecular remission rate and 3-year OS rate was 100.0% and 100.0%, respectively, indicating favorable outcome in patients registered with this study. ATO-related grade 3 and higher non-hematological AEs were observed only in 3. Hence, ATO could be administered safely in children with APL. In conclusion, AML-P13 study conferred favorable outcome in children with APL and provided substantial findings especially in safety and efficacy of ATO.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 32
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Three-year event-free survival rate
- Secondary Outcome Measures
Name Time Method Remission induction rate <br>Molecular remission rate at the end of consolidation therapy <br>Three-year overall survival rate <br>Rate of DIC, APL-DS, and mortality during first remission induction therapy <br>Rate of adverse events during ATO therapy <br>Rate of adverse events