Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Prior allogeneic HCT

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age 60+ with planned HCT for Hematologic Malignancy<br>Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy. | Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy<br>* questionnaires, geriatric assessments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One Year Non-Relapse Mortality | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 1 year | 
| Cumulative Incidence of Frailty | Cumulative Incidence of Frailty determined by score determined through the Hopkins Frailty Phenotype assessment on a scale of 0-5 where a score of 3 or more is considered 'frail'. | 1 Year | 
| Cumulative incidence of disability | Cumulative incidence of disability measured through Lawton instrumental activities of daily living (IADL) assessment. Disability is defined as any assistance needed for a specific IADL domain, and measured by a worsening of disability score by one or more IADL within one year. | 1 Year | 
| Cumulative incidence of admission to a skilled nursing facility | Cumulative incidence of admission to a skilled nursing facility | 1 Year | 
| HRQOL using PROMIS domains | Health Related Quality of Life as measured using the PROMIS Global Health Physical Function, Anxiety, and Depression domains on scales from 0-100 where 50 is the mean score in a healthy reference population. A higher score indicates 'more' of that domain - for this study that would be more physical function, more anxiety, or more depression than the reference population. | 1 Year | 
| Cumulative incidence of serious organ toxicity by day 100 | Cumulative incidence of serious organ toxicity by day 100 | 100 Days | 
| Cumulative incidence of acute grade 2-4 GVHD | Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year | 100 days | 
| Cumulative incidence of acute grade 2-4 GVHD | Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year | 6 months | 
| Cumulative incidence of acute grade 2-4 GVHD | Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year | 1 year | 
| Chronic GVHD requiring treatment with systemic immune-suppression | Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year | 6 months | 
| Chronic GVHD requiring treatment with systemic immune-suppression | Cumulative incidence of acute grade 2-4 GVHD at 100 days, 6 months and 1 year and chronic GVHD requiring treatment with systemic immune-suppression at 6 months and 1 year | 1 year | 
| Survival after development of acute grade 2-4 GVHD | Survival after development of acute grade 2-4 GVHD | 1 year | 
| Cognitive decline at day 100 | Cognitive decline at day 100 as measured using the Montreal Cognitive Assessment (MoCA) as a rapid screening instrument for mild genitive dysfunction. MoCA uses a scale of 0-30 where 26-30 indicates the normal range in healthy populations. Cognitive decline will be defined as a 2 point or greater decline from baseline on total score. | Day 100 |