Midostaurin was given ≥ six months prior to disease relapse.įemales who are non-pregnant and non-nursing.įemales of reproductive age and males must agree to avoid getting pregnant or toįather a child while on therapy and for five months after the last dose of Subjects who previously received midostaurin are allowed if the last dose of Life expectancy of greater than one month. Laboratory values can be outside of this range if secondary to AML disease.Īn ejection fraction of > 45% confirmed by echocardiogram. Karnofsky Performance Status of ≥ 70% or Eastern Cooperative Oncology Group (ECOG) Relapsed AML is defined as any evidence of disease recurrence after achieving CR ofīoth males and females ≥ eighteen years of age For the purpose of this study, refractoryĪML is defined as failure to achieve CR after one cycle of induction chemotherapy and
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Written informed consent obtained from the subject prior to registration on the studyĪnd the ability for the subject to adhere to the study visit schedule and all theĪ diagnosis of relapsed or refractory AML. Morphologic response rate Ĭompare the morphologic response rate (using International Working Group 2003 criteria) of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone.Number of participants with treatment-related adverse events as assessed by National Cancer Institute (NCI) Common Terminology for Adverse Events(CTCAE) v4.0 Īssess the incidence and severity of toxicities of midostaurin and cytarabine using CTCAE v4.0Ĭompare the overall survival of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone.Progression Free Survival Ĭompare the progression free survival of patients receiving midostaurin and cytarabine to that historically achieved in patients receiving cytarabine alone.Outcome Measures Primary Outcome Measures
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