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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


Outcome Timeframe 3, 6, 12 and 24 months

NCTID NCT04982354

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2022-07-05

Completion Date 2031-08-01

Enrollment Target 20

Interventions

DRUG CPX-351

DRUG Midostaurin

DRUG Busulfan

DRUG Melphalan

DRUG Fludarabine

BIOLOGICAL CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor

Locations Recruiting

Miami Cancer Institute at Baptist Health of South Florida

United States, Florida, Miami


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