NCT02328950Unknown不适用
A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Relapse rate at one year after allo-SCT
研究概览
简要总结
A 5 day course of fludarabine and cytarabine (FA) will be administered followed by full intensity conditioning regimen (Bucy) in the setting of allogeneic stem cell transplantation (SCT). The purpose of this study is to explore the antileukemic, immunosuppressive effects and safety of FA as the backbone of a conditioning regiment for the treatment of patients with high-risk, recurrent or refractory acute Leukemia and advanced myelodysplastic syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Aged between 0-65 years
- •Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
- •Patients with advanced MDS
- •Cardiac: Left ventricular ejection fraction ≥ 50%
- •Adequate renal and hepatic function
- •Performance status: Karnofsky ≥ 70%
排除标准
- •Pregnant or lactating females
- •Current participation in another clinical trial
- •Contra-indication to one of the drug of the regimen
- •Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
结局指标
主要结局
Relapse rate at one year after allo-SCT
时间窗: one year
次要结局
- Even free survival(two year)
研究者
Ting YANG
Prof. Dr.
Fujian Medical University
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)CMLMDSAMLLeukemiaNCT01019317M.D. Anderson Cancer Center151
已完成
2 期
A phase II trial of high dose cytarabine and fludarabine without anthracycline for patients with core binding factor acute myeloid leukaemia, measuring efficacy, safety and monitoring minimal residual diseaseCore binding factor acute myeloid leukaemiaCancer - Leukaemia - Acute leukaemiaACTRN12605000152628Australasian Leukaemia and Lymphoma Group53
终止
2 期
Combination Therapy With Fludarabine, Mitoxantrone and Rituximab in Mantle Cell LymphomaMantle Cell LymphomaNCT00183989University of Southern California30
已完成
2 期
A Phase II Study of 5-Fluorouracil Administered as a One Hour Infusion in Combination With Calcium Leucovorin and Interferon Alpha-2A in Advanced Colorectal CancerColorectal NeoplasmsNCT00001428National Cancer Institute (NCI)65
已完成
2 期
Gemcitabine (GFF) in Patients With Pancreatic CancerMetastatic Pancreatic CancerNCT00919282CONKO-Studiengruppe78