NCT01746147已完成不适用
Assessment of Body, Liver and Labile Plasma Iron and Their Association With Outcome and Immunological Recovery in MDS or AML Patients Undergoing Allogeneic Stem Cell Transplantation - ALLIVE (ALLogeneic Iron inVEstigators) Observational Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 134
- 试验地点
- 5
- 主要终点
- Description of dynamic changes of LPI prior, during and after conditioning for allo-SCT using standard descriptive parameters (Mean or Median and appropriate confidence intervals)
研究概览
简要总结
The ALLIVE (ALLogeneic Iron inVEstigators) trial aims at quantifying the extent and dynamic change of LPI occurrence during conditioning and at identifying LPI-predictive peri-transplant parameters. Further points of interest are the improvement of systemic iron overload (SIO) diagnostics and the correlation of different SIO parameters with outcome after transplantation. The results of this trial will help to design prospective interventional studies addressing therapeutic options in patients at risk for SIO-associated toxicity during allogeneic stem-cell transplantation (allo-SCT).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age >= 18 years at the time of signing the informed consent form
- •Signed informed consent
- •Diagnosis of AML or MDS according to WHO classification
- •Planned allogeneic stem cell transplantation after reduced intensity or myeloablative conditioning from related or unrelated donors
- •At risk for iron toxicity as defined by ferritin >500 ng/ml and/or history of more than 10 RBC transfusions prior to allo-SCT
排除标准
- •Claustrophobia or other mental disorders making MRI imaging unbearable for the patient
- •Cardiac pacemakers, metal implants splinters or other contraindications for MRI
- •More than 1 Human leukocyte antigen (HLA) allele or antigen mismatch between donor and recipient
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- •Patients with a history of chronic drug abuse or another illness which does not allow the patient to assess the nature and/or possible consequences of the study
- •Patients who are not likely to follow the trial protocol (lack of willingness to cooperate)
结局指标
主要结局
Description of dynamic changes of LPI prior, during and after conditioning for allo-SCT using standard descriptive parameters (Mean or Median and appropriate confidence intervals)
时间窗: one year
次要结局
- • Area under the Receiver-Operator-Characteristic (ROC) as well as sensitivity and specificity of specific thresholds of serum ferritin and transfusion history for prediction of LIC(one year)
- • Association of serum ferritin and LIC with hematopoietic cell transplantation comorbidity index (HCT-CI)(one year)
- • Cumulative incidence of infections with respect to serum ferritin >1000 µg/l, transfusion burden >20 parasitized red blood cell (PRBC), LIC >125 µmol/g and peak value and duration of detectable labile plasma iron above median(one year)
- • Correlation coefficient of Liver iron concentration (LIC) and duration of detectable LPI during and after conditioning(one year)
- • Median change of serum ferritin and LIC 100 days and 1 year after allo-SCT(one year)
- • Association between immune profile and iron parameters (serum ferritin >1000 µg/l, transfusion burden >20 units RBC, LIC >90 µmol/g and peak value and duration of detectable labile plasma iron above median(one year)
- • Time course of LPI, enhanced labile plasma iron (eLPI), directly chelatable iron (DCI) and hepcidin during allo-SCT(one year)
- • Cumulative incidence of graft versus host disease (aGvHD) grade 2-4 with respect to serum ferritin >1000 µg/l, transfusion burden >20 units of Red blood cells (RBC), LIC >125 µmol/g, peak value and duration of detectable labile plasma iron above median(one year)
- • Association of detectable LPI or eLPI during conditioning and occurrence of elevated liver enzymes during in hospital treatment course for allo-SCT(one year)
- • Cumulative incidence of day 100 non-relapse mortality (NRM) with respect to serum ferritin >1000 µg/l, transfusion burden >20 units of RBC, LIC >125 µmol/g and peak value and duration of detectable labile plasma iron above median(one year)
研究者
研究点 (5)
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