NCT03409081

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with 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 minimal residual disease (MRD) without access to comparable or alternative therapy.

Detailed description

This treatment protocol is being conducted while phase 3 gilteritinib (ASP2215) studies are ongoing in FLT3-mutated AML patients. Patients will be administered treatment over 28-day cycles. Patients will complete visits on cycle 1 days 1, 4, 8, 15; cycle 2 days 1, 15; day 1 of cycles 3 through 6; and day 1 of every 2 cycles thereafter until discontinued from the program. An end of treatment visit will be performed within 7 days after last dose of medicinal product (gilteritinib \[ASP2215\]), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow-up.

Conditions

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

Interventions

Type	Name	Description
DRUG	gilteritinib	oral

Timeline

• First posted: 2018-01-24
• Last updated: 2018-09-13

Locations

6 sites across 3 countries: Australia, Italy, United Kingdom