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Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

NCT03070093 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2021-04-20

No results posted yet for this study

Summary

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission \[CR\], complete remission with incomplete hematologic recovery \[CRi\], complete remission with incomplete platelet recovery \[CRp\]) with MRD without access to comparable or alternative therapy.

Conditions

  • Acute Myeloid Leukemia (AML)
  • FMS-like Tyrosine Kinase-3 (FLT3) Mutations

Interventions

DRUG

gilteritinib

oral

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States
  • Canada
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070093 on ClinicalTrials.gov