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Brief Title: 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)
Official Title: 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)
Study ID: NCT03409081
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Site AU61001, Canberra, , Australia
Site IT39001, Milan, , Italy
Site IT39003, Milan, , Italy
Site UK44001, Birmingham, , United Kingdom
Site UK44003, Bristol, , United Kingdom
Site UK44002, London, , United Kingdom
Name: Study Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR