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1517 : Interim Report of a Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Decitabine As an Epigenetic Priming Agent When Combined with Induction Chemotherapy in Pediatric Patients (pts) with Newly Diagnosed Acute Myelogenous Leukemia (AML)

Researchers

Presenter

  • Margaret E. Macy

Principal Investigators

  • Francoise Mechinaud

  • Peter Tarassoff

  • Mark M Jones

  • Soheil Meshinchi

  • Robert J. Arceci

  • Aru Narendran

  • Frank Alvaro

  • Carola A.S. Arndt

  • Phillip Barnette

  • Jessica Boklan

  • Todd Cooper

  • Laura Martin

  • W Tcheng

Medical Centers

  • Paediatric Oncology, John Hunter Hospital, New South Wales, Australia,

  • Pediatric Oncology, Alberta Childrens Hospital, Calgary, AB, Canada

  • Pediatric Oncology, University Hospital, Lille, France

Locations

  • France

  • Canada

  • Australia

Companies

  • Eisai Co., Ltd.

Study Components

Therapeutic Area

  • Infectious Diseases (ID)

Disease

  • Acute myelocytic leukemia

  • Alpha-thalassemia myelodysplasia syndrome

  • Hypophosphatemic rickets

  • Thrombocytopenia

  • Acute Leukemia

  • Neutropenia

  • Sepsis

Biomarkers

  • Tyrosine 3-Monooxygenase/Tryptophan 5-Monooxygenase Activation Protein Epsilon

Drug/Treatment

  • Decitabine

  • Daunorubicin

  • Cytarabine liposomal

  • Etoposide

  • Etoposide phosphate

  • AC220

Outcome

  • N/A

Study Design

  • open label

  • randomized

  • pharmacokinetics

Phase

  • NA

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • Interim

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