Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
- Registration Number
- NCT04982354
- Lead Sponsor
- Guenther Koehne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 20
- Patients must have a Karnofsky (adult) Performance Status of at least 70%.
- Patients must have adequate organ function
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Treatment CPX-351 Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. Investigational Treatment Midostaurin Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. Investigational Treatment Busulfan Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. Investigational Treatment Fludarabine Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. Investigational Treatment CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts. Investigational Treatment Melphalan Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
- Primary Outcome Measures
Name Time Method Change in the complete remission rate 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) 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) 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 Outcome Measures
Name Time Method Change in the rate of Minimal Residual Disease (MRD) negativity 3, 6, 12 and 24 months Ascertain the rate of MRD negativity by next generation sequencing at sequential time post following induction treatment at complete remission prior to allo Stem Cell Transplantation (SCT)
Correlation of Minimal Residual Disease (MRD) 3, 6, 12 and 24 months Correlation of duration of MRD negative status with duration of complete remission of these patients will be assessed using Spearman's correlation with reported p value.
Trial Locations
- Locations (1)
Miami Cancer Institute at Baptist Health of South Florida
🇺🇸Miami, Florida, United States