NCT00916045终止2 期
Pilot Study of Unrelated Cord Blood Transplantation in Patients With Poor Risk Haematological Malignancies
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年9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
- 40
- 试验地点
- 1
- 主要终点
- Treatment related mortality at day 100
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of unrelated double and single cord blood transplantation in patients with haematological malignancies using reduced-intensity or myeloablative conditioning regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •reduced-intensity conditioning regimen (For both FluMel & FluCyTBI regimens):
- •Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor or 10/10 unrelated bone marrow donor
- •ECOG performance status worse than 2
- •Cardiac insufficiency requiring treatment, symptomatic coronary artery disease or LVEF less than 35%.
- •Hepatic disease, with total bilirubin greater than 2 times upper limit of normal or AST > 5 times upper limit of normal.
- •Severe hypoxaemia, pO2 < 70 mm Hg, with decreased DLCO < 50% of predicted; or mild hypoxemia, pO2 < 80 mm Hg with severely decreased DLCO < 50% of predicted.
- •Impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
- •Previous irradiation that precludes the safe administration of an additional dose of 200 cGy of total body irradiation (TBI).
- •Patients who have received previous treatment with Thymoglobulin®
- •HIV or HTLV 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 the disease indication for transplant
- •Serious concurrent uncontrolled infection e.g. active tuberculosis, mycoses or viral infection
- •Serious psychiatric/ psychological disorders
- •Absence of /inability to provide informed consent
- •Within 6 months of prior myeloablative transplant.
- •Patients with acute leukaemia in morphological relapse/ persistent/ progressive disease
- •Intermediate or high grade NHL, mantle cell NHL and Hodgkin's disease that is refractory or progressive on salvage therapy.
- •Myelofibrosis
研究组 & 干预措施
Reduced intensity conditioning regimen - FluMel
Other
干预措施: Thymoglobulin (Drug)
Myeloblative conditioning regimen
Other
干预措施: Thiotepa (Drug)
Myeloblative conditioning regimen
Other
干预措施: Fludarabine (Drug)
Myeloblative conditioning regimen
Other
干预措施: Intravenous busulphan (Drug)
Myeloblative conditioning regimen
Other
干预措施: Thymoglobulin (Drug)
Myeloblative conditioning regimen
Other
干预措施: Ciclosporin (Drug)
Myeloblative conditioning regimen
Other
干预措施: Mycophenolate mofetil (MMF) (Drug)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Fludarabine (Drug)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Cyclophosphamide (Drug)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Radiotherapy (Radiation)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Thymoglobulin (Drug)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Ciclosporin (Drug)
Reduced intensity conditioning regimen - FluCyTBI
Other
干预措施: Mycophenolate mofetil (MMF) (Drug)
Reduced intensity conditioning regimen - FluMel
Other
干预措施: Fludarabine (Drug)
Reduced intensity conditioning regimen - FluMel
Other
干预措施: Melphalan (Drug)
Reduced intensity conditioning regimen - FluMel
Other
干预措施: Ciclosporin (Drug)
Reduced intensity conditioning regimen - FluMel
Other
干预措施: Mycophenolate mofetil (MMF) (Drug)
结局指标
主要结局
Treatment related mortality at day 100
时间窗: Day 100
次要结局
- Incidence of grade II-IV and III-IV acute GVHD(Days 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Dynamics of EBV infection and immunity following cord blood transplantation(Days 14, 28, 56, 100 and months 6, 9 and 12)
- The development (if any) of transplant associated post transplant lymphoproliferative disease (PTLD)(Days 14, 28, 56, 100 and months 6, 9 and 12)
- One year overall survival for each treatment cohort(1 year)
- Incidence of CMV, adenovirus and EBV activation(Twice a week pre-transplant to day 100 then weekly or as clinically indicated)
- Immune reconstitution(Days 14, 28, 56, 100 and months 6, 9, 12, 18 and 24)
- Incidence of one year relapse or disease progression for each treatment cohort(1 year)
- Chimerism(Days 14 (myeloblative conditioning only), 28, 56, 100 and months 6 and 12)
- Incidence of chronic GVHD during the first year(Day 100 and months 6 and 12)
- Quality of life(Pre-transplant and months 6, 12, 18 and 24)
- Incidence of platelet engraftment by 6 months(Days 14, 28, 56, 100 and month 6)
- Disease free survival at one year post-transplant for each cohort(1 year)
- Incidence of neutrophil engraftment by day 42(Days 14, 28 and 42)
- Incidence of systemic infections(Twice a week pre-transplant to day 100 then weekly or as clinically indicated)
- Identify any possible predictive markers for patients most at risk of PTLD development(Days 14, 28, 56, 100 and months 6, 9 and 12)
研究者
研究点 (1)
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