Overview

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Status:
Not yet recruiting
Trial end date:
2032-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Baptist Health South Florida
Collaborator:
Jazz Pharmaceuticals
Treatments:
Busulfan
Fludarabine
Melphalan
Midostaurin
Criteria
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).