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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

Tracking Information
First Submitted Date June 18, 2019
First Posted Date June 20, 2019
Last Update Posted Date September 16, 2021
Actual Study Start Date July 19, 2019
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2019)
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.
Original Primary Outcome Measures
 (submitted: June 18, 2019)
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.
Change History
Current Secondary Outcome Measures
 (submitted: June 19, 2019)
  • Overall survival [ Time Frame: 1 year ]
    Overall survival
  • 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'.
  • 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.
  • Cumulative incidence of admission to a skilled nursing facility [ Time Frame: 1 Year ]
    Cumulative incidence of admission to a skilled nursing facility
  • 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.
  • Cumulative incidence of serious organ toxicity by day 100 [ Time Frame: 100 Days ]
    Cumulative incidence of serious organ toxicity by day 100
  • 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
  • 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
  • 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
  • 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
  • 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
  • Survival after development of acute grade 2-4 GVHD [ Time Frame: 1 year ]
    Survival after development of acute grade 2-4 GVHD
  • 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.
Original Secondary Outcome Measures
 (submitted: June 18, 2019)
  • Overall survival [ Time Frame: 1 year ]
    Overall survival
  • Cumulative Incidence of Frailty [ Time Frame: 1 Year ]
    Cumulative Incidence of Frailty
  • Cumulative incidence of disability [ Time Frame: 1 Year ]
    Cumulative incidence of disability
  • Cumulative incidence of admission to a skilled nursing facility [ Time Frame: 1 Year ]
    Cumulative incidence of admission to a skilled nursing facility
  • HRQOL [ Time Frame: 1 Year ]
    Health Related Quality of Life
  • Cumulative incidence of serious organ toxicity by day 100 [ Time Frame: 100 Days ]
    Cumulative incidence of serious organ toxicity by day 100
  • 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
  • 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
  • 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
  • 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
  • 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
  • Survival after development of acute grade 2-4 GVHD [ Time Frame: 1 year ]
    Survival after development of acute grade 2-4 GVHD
  • Cognitive decline at day 100 [ Time Frame: Day 100 ]
    Cognitive decline at day 100
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
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)
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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy
Condition Hematologic Malignancy
Intervention Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments
Study Groups/Cohorts Age 60+ with planned HCT for Hematologic Malignancy
Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
Intervention: Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2019)
1100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kelsey Schertz, MPH 763-406-4135 kschertz@nmdp.org
Contact: Erin Leckrone 763-406-5124 eleckron@nmdp.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03992352
Other Study ID Numbers BMT CTN 1704
5U24HL138660-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Center for International Blood and Marrow Transplant Research
Study Sponsor Center for International Blood and Marrow Transplant Research
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
Investigators
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
PRS Account Center for International Blood and Marrow Transplant Research
Verification Date September 2021