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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03409081
Study type Expanded Access
Source Astellas Pharma Inc
Contact
Status No longer available
Phase

See also
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