Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia

Inclusion Criteria:

   - Patients must be newly diagnosed with a clinical diagnosis of acute promyelocytic
   leukemia initially by morphology (bone marrow or peripheral blood); bone marrow is
   highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral
   blood will be accepted; APL is considered a hematological emergency and treatment
   should be initiated as quickly as possible without waiting for molecular or
   cytogenetic/fluorescence in situ hybridization (FISH) confirmation; for patients who
   are unable to begin receiving ATRA in a timely manner following a presumed diagnosis
   of APL, consideration should be given to initiating ATRA and proceeding with treatment
   outside of the AAML0631 protocol; if the RQ-PCR results are known at the time of study
   enrollment, the patient must demonstrate PML-RARA and/or RARA-PML transcripts by
   RQ-PCR to be eligible; patients without evidence of APL by bone marrow or peripheral
   blood morphology but with isolated myeloid sarcoma (myeloblastoma; chloroma, including
   leukemia cutis) are eligible provided that the t(15;17) translocation is documented on
   either marrow or tumor tissue by cytogenetics, FISH, or PCR prior to study enrollment;
   in this situation, touch preps from the tumor site can be evaluated by FISH with
   PML-RARA probes; NOTE: A lumbar puncture is not required to be enrolled on study; if
   the diagnosis of APL is known or suspected, extreme caution must be exercised in
   performing a lumbar puncture during active coagulopathy; in addition a computed
   tomography (CT) or magnetic resonance imaging (MRI) should be considered to rule out
   the possibility of an associated chloroma if central nervous system (CNS) disease is
   suspected or proven; if CNS disease is documented, patients are still eligible

   - No minimal performance status criteria

   - The patient must not have received systemic definitive treatment for APL or other
   suspected leukemia, including cytotoxic chemotherapy, retinoids, or arsenic; prior
   therapy with corticosteroids, hydroxyurea, or leukopheresis will not exclude the
   patient; if a patient received intrathecal cytarabine prior to the diagnosis of APL
   being known, the patient will still be eligible as long as they meet all other
   eligibility requirements

Exclusion Criteria:

   - Pregnant women or nursing mothers are excluded; treatment under this protocol would
   expose an unborn child to significant risks; patients should not be pregnant or plan
   to become pregnant while on treatment; women and men of reproductive potential should
   agree to use an effective means of birth control; there is an extremely high risk of
   fetal malformation if pregnancy occurs while on ATRA in any amount even for short
   periods

   - Patients with a pre-existing prolonged QT Syndrome will not be eligible for this
   protocol due to the use of arsenic trioxide which can prolong the QT interval