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1008 : Efficacy, Safety, and Pharmacokinetics (PK) of Azacitidine (AZA) in Children and Young Adults with Acute Myeloid Leukemia (AML) in the Phase 2 AZA-AML-004 Trial

Researchers

Presenter

  • Dirk Reinhardt

Principal Investigators

  • Henrik Hasle

  • Karsten Nysom

  • Andr Baruchel

  • Franco Locatelli

  • Bouchra Benettaib

  • Noha Biserna

  • Meera Patturajan

  • Mathew Simcock

  • Allison Gaudy

  • C. Michel Zwaan

Medical Centers

  • Department of Pediatric Oncology and Hematology, Essen University Hospital, Essen, Germany

  • Aarhus University Hospital, Aarhus, Denmark

  • Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark

  • Service d'Immuno-hématologie pédiatrique, Hôpital universitaire Robert-Debré AP-HP, Université de Paris, Paris, France

  • Bristol-Myers Sqiubb, Princeton, NJ

  • Celgene, a Bristol-Myers Squibb Company,Uxbridge,United Kingdom

  • Princess Maxima Center for Pediatric Oncology, Netherlands

  • Erasmus MC, Sophia Children's hospital, Rotterdam, Netherlands

Locations

  • Germany

  • Denmark

  • France

  • Italy

  • United States

  • United Kingdom

  • Netherlands

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Acute myelocytic leukemia

Biomarkers

  • Nucleophosmin 1

Drug/Treatment

  • Vidaza

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Multiple Arm

  • Cohort

Phase

  • II

Study Id's

  • NCT02450877

Sponsors

  • N/A

Result

  • N/A

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