|Inclusion Criteria:||1) A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, PCR, or POD test.|
2) Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study.
3) Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early).
4) Patients age 10 years and older are eligible.
5) Women of child-bearing potential must have a negative serum pregnancy test at screening. In addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug.
6) All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study.