Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Guenther Koehne

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Melphalan; Drug: Midostaurin; Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor; Drug: CPX-351; Drug: Fludarabine; Drug: Busulfan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04982354

2019-KOE-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Investigational Treatment

Experimental group

Description:

Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.

Treatment:

Drug: Busulfan

Drug: Fludarabine

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

Drug: CPX-351

Drug: Melphalan

Drug: Midostaurin