Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3… (NCT03070093) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
United States, Canada, Japan
Plain-language summary
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or 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 MRD without access to comparable or alternative therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is considered an adult according to local regulation at the time of signing informed consent.
* Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome (MDS) or therapy-related AML according to World Health Organization (WHO) classification.
* Subject has presence of the FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD in bone marrow or peripheral blood. \[Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.\]
* Subject has refractory or relapsed AML (with or without hematopoietic stem cell transplant \[HSCT\]) or AML in CRc (CR, CRi, CRp) with MRD by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT. \[Specific to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD subjects will not be included.\]
* Subject must wait for at least 5 half-lives after stopping therapy with any investigational agent and before starting ASP2215.
* Subject must meet the following criteria as indicated on clinical laboratory tests:
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x institutional upper limit of normal (ULN)
* Serum total bilirubin ≤ 2.5 mg/dL, except for subjects with Gilbert's syndrome
* Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).
* Subject is able to tolerate or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since gilteritinib has already been approved for marketing for FLT3-mutated AML, does that mean I could access it as a standard prescription rather than through an expanded access program, and which path makes more sense for my situation?
2I have a FLT3 mutation in my AML — can you tell me whether my specific type of FLT3 mutation, ITD or TKD, is the kind that gilteritinib is most likely to target, and how that affects whether it's worth discussing as an option?
3Since this was an expanded access study for patients with relapsed or refractory AML, or AML in complete remission but with minimal residual disease still detectable, which of those categories fits my current situation and how does that change what gilteritinib might realistically be expected to do for me?
4What are the known safety concerns with gilteritinib that have emerged now that it's been approved and used more broadly, and are there any risks that would be especially relevant given my current health status or other medications?
5Before considering gilteritinib, are there standard-of-care treatments or combination approaches I should try first, or is this something that works best at a specific point in my treatment journey?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.