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A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft
Description
This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.
Trial Eligibility
Inclusion Criteria: * Patients must have a Karnofsky (adult) Performance Status of at least 70%. * Patients must have adequate organ function Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Active viral, bacterial or fungal infection * Patient seropositive for Human Immunodeficiency Virus (HIV-I /II); Human T-Cell Lymphotrophic Virus (HTLV -I /II) * Presence of leukemia in the Central Nervous System (CNS).
Study Info
Organization
Baptist Health South Florida
Primary Outcome
Change in the complete remission rate
Interventions
Locations Recruiting
Miami Cancer Institute at Baptist Health of South Florida
United States, Florida, Miami
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