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

Not Recruiting

Trial ID: NCT00866918


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.

Official Title

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® ) During Consolidation

Stanford Investigator(s)


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

   - 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


drug: arsenic trioxide

drug: cytarabine

drug: idarubicin

drug: methotrexate

drug: mitoxantrone hydrochloride

drug: tretinoin

other: diagnostic laboratory biomarker analysis

drug: Mercaptopurine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

New Trial Alerts

Receive email alerts when trials open to patients.