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CHIP-AML22/Quizartinib (Acute Myeloid Leukemia)

Clinical study concerning the safety and efficacy of quizartinib in children and adolescents with FLT3-ITD positive AML with normal NPM1.
Who can enter
  • Children and adolescents with newly diagnosed FLT3-ITD acute myeloid leukemia (AML) with normal NPM1
  • Age: 0 up to and including 18 years


The goal of this study is to investigate how safe the new drug quizartinib is in the treatment of AML with FLT3-ITD and a normal NPM-1 gene. And how effective the drug is.


In some AML-patients a genetic mutation called ‘FLT3-ITD’ is seen in the AML cells, while the so called NPM1 gene is normal. FLT3-ITD is a protein in leukemia cells that causes the AML cells to grow and survive. Patients with this mutation in AML cells in general have a worse prognosis.

Quizartinib is a drug that can slow down the growth of AML cells. Quizartinib is no chemotherapy but a FLT3-protein inhibitor. It is not yet approved for commercial use.
The drug quizartinib has been investigated in adults with relapsed AML with the same mutation in the AML cells. In this study, quizartinib was given alone, or in combination with chemotherapy. An improved reaction was seen compared to the standard chemotherapy. The drug quizartinib is also being investigated in children with relapsed AML. The results from this study are not yet known.

In this study, the new drug quizartinib will be combined with standard chemotherapy as is given according to the CHIP-AML22 protocol (CHIP-AML22/Master).

This scientific study is initiated by the NOPHO-DB-SHIP consortium (a collaboration of 14 different countries in- and outside Europe) and is being performed in several hospitals. In the Netherlands, the study is performed in the Princess Máxima Center for pediatric oncology.

In order to participate in a study please refer to your/your child’s doctor.

Last reviewed

December 29, 2023