Individual Patient Expanded Access Gilteritinib (ASP2215)

AML Clinical Trial

Official title: Individual Patient Expanded Access for Use of Gilteritinib (ASP2215) for Patient Y.A.

Status No longer available

Clinical Trial Summary

The purpose of this study is to provide expanded access to ASP2215 for a single subject with refractory FLT3-mutated AML without access to comparable or alternative therapy.

Clinical Trial Description

This treatment protocol is being conducted in a single pediatric patient while phase 3 ASP2215 studies are ongoing in adult subjects with FLT3-mutated AML.

The subjects will enter the screening period up to 2 weeks prior to the start of treatment.

The subject will be administered treatment over 28-day cycles.

The subjects will complete visits on cycle 1 days 1, 4, 8, 15; cycle 2 days 1, 15, and day 1 of each cycle thereafter until discontinued from the study for toxicity, disease progression, or lack of continued benefit in the judgement of the investigator.

An end of treatment visit will be performed within 7 days after last dose of the investigation product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs earlier, followed by a 30-day follow up. ;

Related Conditions & MeSH terms

• AML

• NCT number: NCT03315299
• Study type: Expanded Access
• Source: Children's Hospital Los Angeles
• Status: No longer available