Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligi… (NCT02624570) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
United States
Plain-language summary
The purpose of this study is to provide access to Midostaurin and gather additional safety data on the combination of Midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Written informed consent must be obtained prior to any screening procedures. Patients must meet all Inclusion Criteria:
* Patient is able to communicate well with the investigator, to understand and comply with the requirements of the study.
* Patients must be 18 years of age or older; elderly patients must be fit to receive intensive induction and consolidation chemotherapy
* Patients must have a documented FLT3 mutation (ITD or TKD)
* Patients must have an ECOG Performance Status of ≤ 2
* Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification (\>20% blasts in the bone marrow and/or peripheral blood), excluding M3 (acute promyelocytic leukemia).
* Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
* AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
* Secondary AML, e.g. patients with antecedent history of treatment for prior malignancy Patients must have the following laboratory values (Direct Bilirubin ≤ 2.5 x ULN, Serum Creatinine ≤ 2.5 x ULN)
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
* Prior therapy for AML with th…