Trials / Terminated
TerminatedNCT04240002
A 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)
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
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the phase 1 portion (dose escalation) of the study was 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) was to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study also assessed safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluated FLT3 inhibition, assessed pharmacokinetics (PK), performed serial measurements of minimal residual disease, obtained preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assessed the acceptability as well as palatability of the formulation. One cycle was defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 had the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).
Conditions
- Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | gilteritinib | Administered orally. |
| DRUG | fludarabine | Administered by intravenous (IV) infusion |
| DRUG | cytarabine | Administered by intravenous (IV) infusion |
| DRUG | granulocyte colony-stimulating factor (G-CSF) | Administered by subcutaneous injection |
Timeline
- Start date
- 2020-09-04
- Primary completion
- 2025-03-11
- Completion
- 2025-03-17
- First posted
- 2020-01-27
- Last updated
- 2026-01-05
- Results posted
- 2026-01-05
Locations
7 sites across 5 countries: United States, Germany, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04240002. Inclusion in this directory is not an endorsement.