Composite Health Assessment Risk Model (CHARM) for Older Adults

Composite Health Assessment Risk Model (CHARM) for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and BioMarkers on Non-Relapse Mortality After Allogeneic Transplant

Sponsors

Lead Sponsor: Center for International Blood and Marrow Transplant Research

Collaborator: 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

Source 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).

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.

Overall Status Recruiting
Start Date 2019-07-19
Completion Date 2022-09-30
Primary Completion Date 2022-07-31
Study Type Observational
Primary Outcome
Measure Time Frame
One Year Non-Relapse Mortality 1 year
Secondary Outcome
Measure Time Frame
Overall survival 1 year
Cumulative Incidence of Frailty 1 Year
Cumulative incidence of disability 1 Year
Cumulative incidence of admission to a skilled nursing facility 1 Year
HRQOL using PROMIS domains 1 Year
Cumulative incidence of serious organ toxicity by day 100 100 Days
Cumulative incidence of acute grade 2-4 GVHD 100 days
Cumulative incidence of acute grade 2-4 GVHD 6 months
Cumulative incidence of acute grade 2-4 GVHD 1 year
Chronic GVHD requiring treatment with systemic immune-suppression 6 months
Chronic GVHD requiring treatment with systemic immune-suppression 1 year
Survival after development of acute grade 2-4 GVHD 1 year
Cognitive decline at day 100 Day 100
Enrollment 1100
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Age 60+ with planned HCT for Hematologic Malignancy

Description: questionnaires, geriatric assessments

Arm Group Label: Age 60+ with planned HCT for Hematologic Malignancy

Eligibility

Sampling Method:

Probability Sample

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

Gender:

All

Minimum Age:

60 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Kelsey Schertz, MPH

Phone: 763-406-4135

Email: [email protected]

Location
Facility: Status: Contact:
City of Hope National Medical Center | Duarte, California, 91010, United States Recruiting Andrew Artz, MD, MS
University of California San Francisco | San Francisco, California, 94143, United States Recruiting Rebecca Olin, MD
Stanford University | Stanford, California, 94305, United States Recruiting Laura Johnston, MD
University of Florida | Gainesville, Florida, 32610, United States Recruiting John Wingard, MD
AdventHealth Orlando | Orlando, Florida, 32804, United States Recruiting Juan Carlos Varela, MD
H. Lee Moffitt Cancer Center | Tampa, Florida, 33612, United States Recruiting Asmita Mishra, MD
Emory University | Atlanta, Georgia, 30322, United States Recruiting Rebecca Klisovic, MD
Northside Hospital | Atlanta, Georgia, 30342, United States Recruiting Lawrence Morris, MD
Loyola University Medical Center | Maywood, Illinois, 60153, United States Recruiting Patrick Stiff, MD
Indiana University | Indianapolis, Indiana, 46202, United States Recruiting Sherif Farag, MD, PhD
Johns Hopkins University | Baltimore, Maryland, 21205, United States Recruiting Phillip Imus, MD
Tufts Medical Center | Boston, Massachusetts, 02111, United States Recruiting Andreas Klein, MD
UMass Memorial Medical Center | Worcester, Massachusetts, 01655, United States Recruiting Zeina Al-Mansour, MD
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting John Maciejewski, MD
Karmanos Cancer Center | Detroit, Michigan, 48201, United States Recruiting Joseph Uberti, MD
University of Minnesota | Minneapolis, Minnesota, 55414, United States Recruiting Mukta Arora, MD
Mayo Clinic Rochester | Rochester, Minnesota, 55902, United States Recruiting William Hogan, MD
Washington University | Saint Louis, Missouri, 63130, United States Recruiting Iskra Pusic, MD
UNC Chapel Hill | Chapel Hill, North Carolina, 27599, United States Recruiting Shannon McCurdy, MD
Levine Cancer Institute | Charlotte, North Carolina, 28204, United States Recruiting T. Greg Knight, MD
Duke University | Durham, North Carolina, 27710, United States Recruiting Mitchell Horwitz, MD
Wake Forest Baptist Health | Winston-Salem, North Carolina, 27157, United States Recruiting Dianna Howard, MD
Siedman Cancer Center | Cleveland, Ohio, 44106, United States Recruiting Kirsten Boughan, DO
Cleveland Clinic | Cleveland, Ohio, 44195, United States Recruiting Ronald Sobecks, MD
The Ohio State Universtiy | Columbus, Ohio, 43210, United States Recruiting Sarah Wall, MD
Oregon Health and Science University | Portland, Oregon, 97239, United States Recruiting Rebecca Saultz, MD
University of Pennsylvania | Philadelphia, Pennsylvania, 19104, United States Recruiting Shannon McCurdy, MD
Prisma Health - Upstate | Greenville, South Carolina, 29615, United States Recruiting Suzanne Fanning, DO
Baylor College of Medicine | Houston, Texas, 77030, United States Recruiting George Carrum, MD
Texas Transplant Institute | San Antonio, Texas, 78229, United States Recruiting Behyar Zoghi, MD
University of Virginia | Charlottesville, Virginia, 22903, United States Recruiting Tamila Kindwall-Keller, DO
Virginia Commonwealth | Richmond, Virginia, 23298, United States Recruiting John McCarty, MD
Fred Hutchinson Cancer Research Center | Seattle, Washington, 98109, United States Recruiting Mohamed Sorror, MD, MSc
West Virginia University Hospitals, Inc. | Morgantown, West Virginia, 26506, United States Recruiting Lauren Veltri, MD
University of Wisconsin | Madison, Wisconsin, 53792, United States Recruiting Kalyan Nadiminti, MD
Medical College of Wisconsin | Milwaukee, Wisconsin, 53226, United States Recruiting Lyndsey Runaas, MD
Location Countries

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Age 60+ with planned HCT for Hematologic Malignancy

Description: Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.

Acronym BMT CTN 1704
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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