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

NCT03992352 | Completed DMC

• 2 other identifiers: BMT CTN 17045U24HL138660-02
• Study Type: observational
• Target: 1,229
• Locations: 1 country
• Sites: 50

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).

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• One Year Non-Relapse Mortality

  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 Outcomes (13)

• 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

Study Arms (1)

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

Interventions

Age 60+ with planned HCT for Hematologic Malignancy DIAGNOSTIC_TEST

questionnaires, geriatric assessments

Age 60+ with planned HCT for Hematologic Malignancy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \. Prior allogeneic HCT

Sponsors & Collaborators

• Center for International Blood and Marrow Transplant Research: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Cancer Institute (NCI): collaborator
• Blood and Marrow Transplant Clinical Trials Network: collaborator
• National Marrow Donor Program: collaborator

Study Sites (50)

Mayo Clinic Arizona and Phoenix Children's Hospital

Phoenix, Arizona, 85054, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Memorial Cancer Institute

Pembroke Pines, Florida, 33028, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, 46107, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Kansas, Blood and Marrow Transplant Program

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital Bone Marrow Transplant Program

Detroit, Michigan, 48202, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Nebraska Medicine

Omaha, Nebraska, 68198, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Siedman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State Universtiy

Columbus, Ohio, 43210, United States

Location

HCA Health Services of Oklahoma, Inc., University of OK

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Virginia Commonwealth

Richmond, Virginia, 23298, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

West Virginia University Hospitals, Inc.

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (31)

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  BACKGROUND

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  BACKGROUND

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• Artz AS, Logan BR, Saber W, Geller N, Bellach A, Kou J, Wood WA, McCarty J, Knight TG, Runaas L, Johnston L, Walston JD, Nakamura R, Mishra A, Uberti J, Dahi PB, Saultz JN, McCurdy SR, Morris LE Jr, Imus P, Hogan WJ, Nadiminti KV, Bhatt VR, Olin RL, Maakaron JE, Sobecks RM, Wall SA, Mattila D, Protz B, Devine SM, Horowitz MM, Sorror ML. CHARM is Prognostic of Geriatric Morbidity and Toxicity after Allogeneic Transplant for Older Adults: BMT CTN 1704 Study. Blood Adv. 2025 Nov 21:bloodadvances.2025018340. doi: 10.1182/bloodadvances.2025018340. Online ahead of print.

  PMID: 41269781 DERIVED

• Sorror ML, Saber W, Logan B, Geller N, Bellach A, Kou J, Wood W, McCarty JM, Knight TG, Runaas L, Johnston L, Walston J, Nakamura R, Jarrett L, Mishra A, Uberti J, Dahi PB, Saultz JN, McCurdy SR, Morris LE, Imus PH, Hogan WJ, Nadiminti K, Bhatt VR, Olin R, Maakaron J, Sobecks R, Wall SA, Mattila D, Protz B, Devine SM, Horowitz MM, Artz AS. Novel composite health assessment risk model for older allogeneic transplant recipients: BMT-CTN 1704. Blood Adv. 2025 Jul 8;9(13):3268-3280. doi: 10.1182/bloodadvances.2025015793.

  PMID: 40101246 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Artz, MD, MS

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

• Mohamed Sorror, MD, MSc

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Wael Saber, MD, MS

  Medical College of Wisconsin/CIBMTR

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: July 19, 2019
• Primary Completion: May 29, 2023
• Study Completion: May 30, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (50)