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Completed

NCT Number: NCT03992352

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

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).

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Key information

Conditions

Hematologic Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona and Phoenix Children's Hospital, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Prior allogeneic HCT

Treatment and study plan

Age 60+ with planned HCT for Hematologic Malignancy

Diagnostic Test

questionnaires, geriatric assessments

Primary outcomes

  1. One Year Non-Relapse Mortality

    Time frame: 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.

Secondary outcomes

  1. Overall survival

    Time frame: 1 year

    Overall survival

  2. Cumulative Incidence of Frailty

    Time frame: 1 Year

    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'.

  3. Cumulative incidence of disability

    Time frame: 1 Year

    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.

  4. Cumulative incidence of admission to a skilled nursing facility

    Time frame: 1 Year

    Cumulative incidence of admission to a skilled nursing facility

  5. HRQOL using PROMIS domains

    Time frame: 1 Year

    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.

  6. Cumulative incidence of serious organ toxicity by day 100

    Time frame: 100 Days

    Cumulative incidence of serious organ toxicity by day 100

  7. Cumulative incidence of acute grade 2-4 GVHD

    Time frame: 100 days

    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

  8. Cumulative incidence of acute grade 2-4 GVHD

    Time frame: 6 months

    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

  9. Cumulative incidence of acute grade 2-4 GVHD

    Time frame: 1 year

    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

  10. Chronic GVHD requiring treatment with systemic immune-suppression

    Time frame: 6 months

    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

  11. Chronic GVHD requiring treatment with systemic immune-suppression

    Time frame: 1 year

    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

  12. Survival after development of acute grade 2-4 GVHD

    Time frame: 1 year

    Survival after development of acute grade 2-4 GVHD

  13. Cognitive decline at day 100

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

  • Blood and Marrow Transplant Clinical Trials Network
  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • National Marrow Donor Program

Registry information

Official study title

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)

Acronym: BMT CTN 1704

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 20, 2019
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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