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

February 5, 2024 updated by: Center for International Blood and Marrow Transplant Research

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona and Phoenix Children's Hospital
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Cancer Institute
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana Blood and Marrow Transplantation
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas, Blood and Marrow Transplant Program
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of MIchigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Bone Marrow Transplant Program
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Nebraska Medicine
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital/Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • Siedman Cancer Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State Universtiy
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • HCA Health Services of Oklahoma, Inc., University of OK
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health - Upstate
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • San Antonio, Texas, United States, 78229
        • Texas Transplant Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Hospitals, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
Overall survival
1 year
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'.
1 Year
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.
1 Year
Cumulative incidence of admission to a skilled nursing facility
Time Frame: 1 Year
Cumulative incidence of admission to a skilled nursing facility
1 Year
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.
1 Year
Cumulative incidence of serious organ toxicity by day 100
Time Frame: 100 Days
Cumulative incidence of serious organ toxicity by day 100
100 Days
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
100 days
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
6 months
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
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
6 months
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
1 year
Survival after development of acute grade 2-4 GVHD
Time Frame: 1 year
Survival after development of acute grade 2-4 GVHD
1 year
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.
Day 100

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for International Blood and Marrow Transplant Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
National Marrow Donor Program
Blood and Marrow Transplant Clinical Trials Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Artz, MD, MS, City of Hope Medical Center
  • Principal Investigator: Mohamed Sorror, MD, MSc, Fred Hutchinson Cancer Center
  • Study Chair: Wael Saber, MD, MS, Medical College of Wisconsin/CIBMTR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BMT CTN 1704
  • 5U24HL138660-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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