Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Inclusion Criteria:

* Previously untreated patients with a morphologic diagnosis of APL, confirmed by demonstration of t(15;17) using conventional cytogenetics OR florescence in situ hybridization (FISH), OR a positive RT-PCR assay for PML-RAR at the subject's local institution.
* Age ≥18 years. Karnofsky performance status of ≥ 60%.
* Adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a creatinine clearance of \> 60 ml/min.
* Adequate hepatic function as demonstrated by a bilirubin \< 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 2.5 times the upper limit of normal.
* Normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50% on echocardiogram or MUGA scan.
* QTc ≤ 500 msec on baseline ECG.
* Negative serum pregnancy test in women of childbearing potential.
* Ability to swallow oral medication.
* Men and women of child-bearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished.
* Patients with central nervous system involvement by APL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice.

Exclusion Criteria:

* Previous treatment for APL, except tretinoin, which may be given for up to 7 days prior to study entry.
* Active serious infections not controlled by antibiotics.
* Pregnant women or women who are breast-feeding.
* Concurrent active malignancy requiring immediate therapy.
* Clinically significant cardiac disease (NY Heart Association Class III or IV), including chronic arrhythmias, or pulmonary disease.
* Other serious or life-threatening conditions deemed unacceptable by the principal investigator.