NCT00915811终止2 期
Pilot Study of Reduced Intensity Haematopoietic Stem Cell Transplantation in Patients With Poor Risk Myelodysplastic Syndrome and Acute Myeloid Leukaemia Utilising Conditioning With Fludarabine, Busulphan and Thymoglobulin
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Treatment related mortality to Day 100
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of conditioning with fludarabine, busulphan and thymoglobuline in patients with myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative disorders (MDS/MPD) or acute myeloid leukaemia (AML) undergoing haematopoietic stem cell allograft with granulocyte colony-stimulating factor (G-CSF)-mobilised peripheral blood stem cells (PBSC) (or bone marrow) from HLA compatible sibling 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Selection
- •Availability of a HLA compatible sibling donor
- •Age >18 years
- •Myelodysplastic Syndromes with IPSS Intermediate-2 or High.
- •Poor risk acute myeloid leukaemia, de novo or transformed from MDS
- •Ineligibility for standard conditioning allograft due to age or co-existing morbidities
- •Donor selection
- •Related donors compatible for HLA-A, B, C, DRB1 and DQB1 by molecular typing.
排除标准
- •Patient selection
- •Cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
- •Hepatic disease, with AST > 2 times normal.
- •Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 70% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 60% of predicted.
- •Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
- •Patients who have received previous treatment with Thymoglobuline
- •HIV-positive patients.
- •Female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
- •Life expectancy severely limited by diseases other than MDS or MPD.
- •Serious concurrent untreated infection
- •Patients with limited life expectancy for other reasons
- •Serious psychiatric/ psychological disorders
- •Absence of /inability to provide informed consent
- •Donor selection
- •Age >75 years, unless independently assessed to be medically fit to donate
- •Donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
- •Donors who are HIV-positive, or hepatitis B or C PCR positive.
- •Donors who are medically unsuitable to donate
研究组 & 干预措施
FBATG
Experimental
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
干预措施: Fludarabine (Drug)
FBATG
Experimental
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
干预措施: Busulphan (Drug)
FBATG
Experimental
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
干预措施: Thymoglobuline (Anti-thymocyte globulin [rabbit]) - Genzyme (Drug)
FBATG
Experimental
Haematopoietic stem cell transplantation utilising conditioning with Fludarabine, Busulphan and Thymoglobuline
干预措施: Haematopoietic stem cell infusion (Procedure)
结局指标
主要结局
Treatment related mortality to Day 100
时间窗: Days 28, 56 and 100
次要结局
- Incidence of single or multi-organ acute toxicity(Days 28, 56 and 100)
- Disease free survival/relapse risk(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Incidence of graft failure/rejection(Days 28, 56 and 100)
- Incidence of acute graft-versus-host disease(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Incidence of systemic infections(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- EBV activation(Fortnightly for first 6 weeks after transplantation and then weekly for the first 6 months.)
- Overall survival(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
研究者
研究点 (1)
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