Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 … (NCT03409081) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
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)
Australia, Italy, United Kingdom
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient is considered an adult according to local regulation at the time of signing informed consent.
* Patient has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome or therapy-related AML according to World Health Organization (WHO) classification as determined by pathology review at the treating institution.
* Patient has presence of the FLT3 mutation (internal tandem duplication and/or tyrosine kinase domain \[D835/I836\] mutation) in bone marrow or peripheral blood.
* Patient has refractory or relapsed AML (with or without Hematopoietic stem cell transplant (HSCT)) or has AML in CRc (CR, CRi, CRp) with Minimal residual disease (MRD) by flow cytometry or genetic testing for the FLT3 mutation after induction/consolidation regimen or HSCT.
* There is no comparable or satisfactory alternative therapy to treat the patient's AML.
* Patient has not received any chemotherapy or investigational agent within at least 5 half-lives after stopping that drug and before starting gilteritinib (ASP2215).
* Patient must meet the following criteria as indicated on clinical laboratory tests:
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 institutional upper limit of normal
* Serum total bilirubin ≤ 2.5 mg/dL, except for patients with Gilbert's syndrome
* Serum potassium and serum magnesium ≥ institutional lower limit of normal.
* Patient is able to tolerate oral administration of gilteritinib (ASP2215).
* Pa…