Composite Health Assessment Risk Model (CHARM) for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and BioMarkers on Non-Relapse Mortality After Allogeneic Transplant (BMT CTN 1704)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,229
- 试验地点
- 50
- 主要终点
- One Year Non-Relapse Mortality
研究概览
简要总结
Prospective observational multicenter study of allogeneic Hematopoietic Stem Cell Transplantation (HCT) in recipients 60 years and older to assess important determinants of health status to be combined into a composite health risk model to improve risk assessment of non-relapse mortality (NRM).
详细描述
At baseline, standardized Geriatric Assessment (GA) tools incorporating subject reported data and bedside testing will be collected. HCT-Comorbidity Index (CI) scores will be assigned and C-reactive protein (CRP) and albumin will be measured locally. Serial measures at 3, 6, and 12 months for frailty, skilled facility admission, and quality of life (QOL) using PROMIS measures for physical function, depression and anxiety will be determined. Graft Versus Host Disease (GVHD) through one year, serious toxicities through day 100, cognitive status at day 100 and causes of death will be captured.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is > 60.0 years old at time of enrollment.
- •Hematological malignancy as an indication for allogeneic transplantation.
- •Eligible for allogeneic transplantation based on institutional standards
- •First allogeneic transplant planned. Any conditioning regimen and allogeneic donor is acceptable.
- •Able to speak and read English. Spanish, and Mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages.
- •Written informed consent
排除标准
- •Prior allogeneic HCT
结局指标
主要结局
One Year Non-Relapse Mortality
时间窗: 1 year
To determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of NRM by analyzing data collected from all measures pre and post transplant.
次要结局
- Cumulative Incidence of Frailty(1 Year)
- HRQOL using PROMIS domains(1 Year)
- Cumulative incidence of serious organ toxicity by day 100(100 Days)
- Cumulative incidence of admission to a skilled nursing facility(1 Year)
- Overall survival(1 year)
- Cumulative incidence of disability(1 Year)
- Cognitive decline at day 100(Day 100)
- Cumulative incidence of acute grade 2-4 GVHD(1 year)
- Chronic GVHD requiring treatment with systemic immune-suppression(1 year)
- Survival after development of acute grade 2-4 GVHD(1 year)