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Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Treatment of Newly Diagnosed AML


Hematopoietic growth factors such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) during AML induction therapy have been evaluated in multiple placebo-controlled studies in adults with AML in attempts to reduce the toxicity associated with prolonged myelosuppression.[16,17] These studies have generally shown a reduction of several days in the duration of neutropenia with the use of either G-CSF or GM-CSF [16] but have not shown significant effects on treatment-related mortality or OS.[16] A randomized study in children with AML evaluating G-CSF administered following induction chemotherapy showed a reduction in duration of neutropenia, but no difference in infectious complications or mortality.[18] A higher relapse rate has been reported for children with AML expressing the differentiation defective G-CSF receptor isoform IV.[19] Thus, routine prophylactic use of hematopoietic growth factors is not recommended for children with AML.

Treatment options under clinical evaluation

The following are examples of national and/or institutional clinical trials that are currently being conducted. Information about ongoing clinical trials is available from the NCI Web site.

  • AML08(Clofarabine Plus Cytarabine Versus Conventional Induction Therapy and a Study of Natural Killer Cell Transplantation in Newly Diagnosed AML): St. Jude Children's Research Hospital is conducting a randomized trial for children with newly diagnosed AML. This trial compares two induction regimens: cytarabine/daunorubicin/etoposide (ADE) versus clofarabine/cytarabine. Responses are assessed via morphology and flow cytometry (MRD) at the end of the induction phase.
  • COG-AAML1031 (Bortezomib and Sorafenib Tosylate in Patients With Newly Diagnosed AML With or Without Mutations): COG-AAML1031 uses an ADE induction therapy backbone. For patients without FLT3-ITD–positive AML, the study is using a randomized design to evaluate whether the addition of bortezomib throughout the course of therapy improves EFS and OS. For patients with high allelic ratio FLT3-ITD–positive AML, the primary objective is to evaluate the feasibility of combining sorafenib (a small molecule FLT3 inhibitor) with standard chemotherapy. A secondary objective for this patient population is to determine the antileukemic activity of sorafenib for FLT3-ITD–positive AML.

Central Nervous System (CNS) Prophylaxis for AML

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