Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
Condition: Childhood Acute Promyelocytic Leukemia With PML-RARA; Myeloid Neoplasm
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: Arsenic Trioxide; Cytarabine; Diagnostic Laboratory Biomarker Analysis; Idarubicin; Mercaptopurine; Methotrexate; Mitoxantrone Hydrochloride; Tretinoin
Intervention description: Given IV; Given IT or IV; Correlative studies; Given IV; Given orally; Given orally; Given IV; Given orally
Intervention MeSH terms: Vitamins; Vitamin A; Cytarabine; Methotrexate; Mercaptopurine; Mitoxantrone; Idarubicin; Tretinoin; Retinol palmitate; Arsenic Trioxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 2 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase III trial is studying combination chemotherapy to see how well it works in
      treating young patients with newly diagnosed acute promyelocytic leukemia. Drugs used in
      chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more cancer cells.
    

Eligibility criteria:

        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