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)
The purpose of the phase 1 portion (dose escalation) of the study will be to establish an
optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine
maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine,
cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2
portion (dose expansion) is to determine complete remission (CR) rates and composite complete
remission (CRc) rates after two cycles of therapy. The study will also assess safety,
tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3
inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual
disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall
survival (OS) rate and assess the acceptability as well as palatability of the formulation.
One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment
cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with
gilteritinib (for up to 2 years).
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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