Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Sponsor: Guenther Koehne

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04982354

Patient View

This pilot study evaluates CPX-351 with midostaurin for induction and consolidation in high-risk FLT3 mutated AML patients, followed by CD34+-selected allogeneic stem cell transplant. Eligibility requires a Karnofsky Performance Status of ≥70% and adequate organ function. Interventions include CPX-351, midostaurin, busulfan, melphalan, fludarabine, and stem cell transplant.

Patient Parameters

Program Overview

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.

Eligibility 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).

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