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)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512469-15-00

Acronym

2215-CL-0603

Enrollment

Registered

2024-05-23

Start date

2020-12-08

Completion date

2025-03-17

Last updated

2025-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Brief summary

• Phase 1: Determination of MTD and/or RP2D • Phase 2: o CRc rates (overall best response) after 2 cycles of therapy. o CR rates after 2 cycles of therapy; CR rate will be further described by the duration of CR (only for USA).

Detailed description

Inhibition of phosphorylated FLT3 (pFLT3) measured by PIA assay, Gilteritinib plasma concentration, Pharmacokinetic parameters (e.g., oral clearance [CL/F], apparent volume of distribution [Vd/F], maximum concentration [Cmax], time of maximum concentration [tmax], area under the concentration-time curve [AUC]) of gilteritinib, Safety, tolerability and toxicity assessments of gilteritinib when given in combination with FLAG, EFS rate, OS rate, MRD assessment, Acceptability and palatability assessment of the formulation

Interventions

DRUGZarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe

DRUGGilteritinib

DRUGARA-cell® 40 mg Injektion 20 mg/ml Injektionslösung / Konzentrat zur Herstellung einer Infusionslösung

DRUGBendarabin 50 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung

DRUGCitarabina Hikma 1 g/10mL Soluzione Iniettabile

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
• Phase 1: Determination of MTD and/or RP2D • Phase 2: o CRc rates (overall best response) after 2 cycles of therapy. o CR rates after 2 cycles of therapy; CR rate will be further described by the duration of CR (only for USA).	—

Secondary

Measure	Time frame
Inhibition of phosphorylated FLT3 (pFLT3) measured by PIA assay, Gilteritinib plasma concentration, Pharmacokinetic parameters (e.g., oral clearance [CL/F], apparent volume of distribution [Vd/F], maximum concentration [Cmax], time of maximum concentration [tmax], area under the concentration-time curve [AUC]) of gilteritinib, Safety, tolerability and toxicity assessments of gilteritinib when given in combination with FLAG, EFS rate, OS rate, MRD assessment, Acceptability and palatability assessment of the formulation	—

Measure

Time frame

—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026