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

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ClinicalTrials.gov Identifier: NCT03992352
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Brief Summary:
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).

Condition or disease Intervention/treatment
Hematologic Malignancy Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Age 60+ with planned HCT for Hematologic Malignancy
Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy
Criteria

Inclusion Criteria:

  1. Subject is > 60.0 years old at time of enrollment.
  2. Hematological malignancy as an indication for allogeneic transplantation.
  3. Eligible for allogeneic transplantation based on institutional standards
  4. First allogeneic transplant planned. Any conditioning regimen and allogeneic donor is acceptable.
  5. Able to speak and read English. Spanish, and Mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages.
  6. Written informed consent

Exclusion Criteria:

1. Prior allogeneic HCT


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992352


Contacts
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Contact: Kelsey Schertz, MPH 763-406-4135 kschertz@nmdp.org
Contact: Erin Leckrone 763-406-5124 eleckron@nmdp.org

Locations
Show Show 36 study locations
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Investigators
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Principal Investigator: Andrew Artz, MD, MS City of Hope Medical Center
Principal Investigator: Mohamed Sorror, MD, MSc Fred Hutchinson Cancer Research Center
Study Chair: Wael Saber, MD, MS Medical College of Wisconsin/CIBMTR
Publications:
Muffly L, Pasquini MC, Martens M, et al. Increasing Use of Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients Age 70 Years and Older: A CIBMTR Study of Trends and Outcomes. Biology of Blood and Marrow Transplant.22:S68-S69.
Basak GW, Sánchez-Ortega I, Beohou E, et al. Allogeneic Hematopoietic Cell Transplantation in Elderly Patients Aged 65 and Older: A Retrospective Analysis By the Complications and Quality of Life Working Party of the EBMT. Blood. 2016;128:681-681.
Olin RL, Andreadis C, Martin TG, et al. Comprehensive Geriatric Assessment Identifies Significant Functional Impairments in Older Hematopoietic Cell Transplant Recipients. Biology of Blood and Marrow Transplant.20:S65-S66.

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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT03992352    
Other Study ID Numbers: BMT CTN 1704
5U24HL138660-02 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases