AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 8
- 主要终点
- Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry
研究概览
简要总结
The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy-haploidentical NK cell transplantation-in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.
详细描述
The overall objective of this protocol is to improve the cure rate of acute myeloid leukemia (AML).
We will compare the immunologic complete response rate after one course of therapy in patients who receive cytarabine + daunorubicin + etoposide (ADE) with that in patients who receive clofarabine + cytarabine (Clo/AraC)
Secondary objectives include
- To estimate the event-free survival (EFS) of standard risk (SR) patients who receive chemotherapy alone and the EFS of SR patients who receive chemotherapy followed by natural killer (NK) cell transplantation.
Exploratory Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than or equal to 21 years at time of study entry.
- •No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.
- •Written informed consent according to institutional guidelines
- •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- •Male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
排除标准
- •Down syndrome
- •Acute Promyelocytic Leukemia (APL)
- •Juvenile Myelomonocytic Leukemia (JMML)
- •Fanconi anemia (FA)
- •Kostmann syndrome
- •Shwachman syndrome
- •Other bone marrow failure syndromes
- •Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- •Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy.
- •Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Pregnant or lactating patients.
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
研究组 & 干预措施
ADE
Cytarabine + Daunorubicin + Etoposide
NK cells for infusion are prepared using the CliniMACS System.
干预措施: Cytarabine (Drug)
ADE
Cytarabine + Daunorubicin + Etoposide
NK cells for infusion are prepared using the CliniMACS System.
干预措施: Daunorubicin (Drug)
ADE
Cytarabine + Daunorubicin + Etoposide
NK cells for infusion are prepared using the CliniMACS System.
干预措施: Etoposide (Drug)
ADE
Cytarabine + Daunorubicin + Etoposide
NK cells for infusion are prepared using the CliniMACS System.
干预措施: CliniMACS (Device)
Clo/AraC
Clofarabine + Cytarabine
NK cells for infusion are prepared using the CliniMACS System.
干预措施: Cytarabine (Drug)
Clo/AraC
Clofarabine + Cytarabine
NK cells for infusion are prepared using the CliniMACS System.
干预措施: Clofarabine (Drug)
Clo/AraC
Clofarabine + Cytarabine
NK cells for infusion are prepared using the CliniMACS System.
干预措施: CliniMACS (Device)
结局指标
主要结局
Day 22 Minimal Residual Disease (MRD) Measured by Flow Cytometry
时间窗: Day 22 MRD measurement after one course of therapy
MRD-negative is defined as \<0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as \>=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
次要结局
- Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Alone.(3 years after completion of therapy)
- Event-free Survival of Standard Risk Patients Who Receive Chemotherapy Followed by Natural Killer Cell Transplantation.(3 years after completion of therapy)