Clinical Trial TitleA phase 3 multi-center, randomized, double-blind, placebo-controlled trial of the FLT3 inhibitor gilteritinib (ASP2215) administered as maintenance therapy following induction/consolidation therapy for subjects with FLT3/ITD AML in 1st complete remission.
Clinical Trial Protocol Description:
Study for FLT3/ITD AML patients in first complete remission, which administers study drug as maintenance therapy following induction/consolidation therapy and to collect additional data on treatment safety.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Allow access to your diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test that is being developed in parallel with gilteritinib.
- Have confirmed morphologically documented AML in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
- Will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.
- Are less than 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior allogeneic transplant.
- Have QTcF interval > 450 msec (average of triplicate determinations).
- Have Long QT Syndrome.
- Have hypokalemia and hypomagnesemia at screening (defined as values below LLN).
This is a partial list of inclusion and exclusion criteria.