A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)



In this phase I/II trial  children, adolescents and young adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) relapsed or refractory Acute Myeloid Leukemia (AML) are treated with gilteritinib. Patients > 6 months and <21 years of age are eligible.   

Gilteritinib inhibts the AXL-receptor-tyrosinkinase. This disrupts the growth factor signal pathway and leads to apoptosis of the affected cells. The substance can also be classified as a FLT3 inhibitor or a multikinase inhibitor, as it also inhibits FLT3 and ALK. The FLT3 receptor, which plays an important role in the differentiation of haematopoietic stem cells, is inhibited and leads to the death of cells that have an internal tandem duplication of the FLT receptor. Gilteritinib is given in the form of film-coated tablets.

The aim of the study is to test the safety, pharmacokinetics and effectiveness of the investigational drug in combination with standard chemotherapy.

Main inclusion criteria

  • Age: 6 months to 20 years at screening visit
  • Relapsed or refractory acute myeloid leukema (AML) 
  • Karnofsky or Lansky > 50


Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

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