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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the complete remission rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a Karnofsky (adult) Performance Status of at least 70%.
- •Patients must have adequate organ function
排除标准
- •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).
研究组 & 干预措施
Investigational Treatment
Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor (Biological)
结局指标
主要结局
Change in the complete remission rate
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Guenther Koehne
Deputy Director and Chief of Blood and Marrow Transplant, Hematologic Oncology and Benign Hematology
Baptist Health South Florida