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
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in the complete remission rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: CPX-351 (Drug)
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: Midostaurin (Drug)
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: Busulfan (Drug)
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: Melphalan (Drug)
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: Fludarabine (Drug)
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
Intervention: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor (Biological)
Outcomes
Primary Outcomes
Change in the complete remission rate
Time Frame: 3, 6, 12 and 24 months
Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients
Change in Progression Free Survival (PFS)
Time Frame: 3, 6, 12 and 24 months
to determine the PFS of these patients following allo SCT. To estimate PFS the Kaplan-Meier method will be used.
Change in Overall Survival (OS)
Time Frame: 3, 6, 12 and 24 months
to determine the OS of these patients following allo SCT. To estimate OS the Kaplan-Meier method will be used.
Secondary Outcomes
- Change in the rate of Minimal Residual Disease (MRD) negativity(3, 6, 12 and 24 months)
- Correlation of Minimal Residual Disease (MRD)(3, 6, 12 and 24 months)
Investigators
Guenther Koehne
Deputy Director and Chief of Blood and Marrow Transplant, Hematologic Oncology and Benign Hematology
Baptist Health South Florida