Eligibility Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA NCT02339740

patients must be newly diagnosed with a clinical diagnosis of apl (initially by morphology of 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

if the rq-pcr results are known at the time of study enrollment, the patient must demonstrate the pml-raralpha transcript by rq-pcr to be eligible

note: a lumbar puncture is not required in order to be enrolled on study nor are lumbar punctures recommended at the time of diagnosis; if the diagnosis of apl is known or suspected, diagnostic lumbar punctures in patients with neurologic symptoms should be deferred until any coagulopathy is corrected; if central nervous system (cns) disease is suspected or proven, a computed tomography (ct) or magnetic resonance imaging (mri) should be considered to rule out the possibility of an associated chloroma; if cns disease is documented, patients are still eligible and will receive protocol directed intrathecal treatments

patients may receive up to a maximum of 5 days of pre-treatment with atra prior to administration of protocol therapy

treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it should be noted that lumbar puncture and intrathecal therapy at initial diagnosis of apl is not recommended

all patients and/or their parents or legal guardians must sign a written informed consent

all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met

patients with secondary apl are excluded; this includes all patients with apl that may have resulted from prior treatment (chemotherapy or radiation)

patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of apl by bone marrow or peripheral blood morphology are excluded

patients with a pre-existing diagnosis of a prolonged qt syndrome (even if corrected qt interval [qtc] is normal at the time of apl diagnosis) are excluded

patients with a baseline qtc of > 450 msec are excluded; bazett's formula is to be used for measurement of the corrected qt interval: the qt interval (msec) divided by the square root of the rr interval (msec)

patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded

patients with right bundle branch block plus left anterior hemiblock, bifascicular block are excluded

patients with serum creatinine > 3.0 mg/dl and patients on active dialysis for renal dysfunction are excluded

patients who have received treatment with any other cytotoxic chemotherapy prior to beginning protocol therapy (other than allowed in above criteria) are excluded

female patients who are pregnant are exclude; patients should not be pregnant or plan to become pregnant while on treatment; a pregnancy test prior to enrollment is required for female patients of childbearing potential

lactating females who plan to breastfeed their infants are excluded

sexually active patients of reproductive potential who have not agreed to be abstinent or use 2 forms of effective contraception during treatment through 1 month off therapy are excluded