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

Hematologic Malignancy Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992352
• Other study ID #: BMT CTN 1704
• Secondary ID: 5U24HL138660-02
• Status: Completed
• Start date: July 19, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: February 2024
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1229
• Est. completion date: May 30, 2023
• Est. primary completion date: May 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Diagnostic Test:
• Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Indiana Blood and Marrow Transplantation	Beech Grove	Indiana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Chicago Medicine	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Siedman Cancer Center	Cleveland	Ohio
United States	The Ohio State Universtiy	Columbus	Ohio
United States	Henry Ford Hospital Bone Marrow Transplant Program	Detroit	Michigan
United States	Karmanos Cancer Center	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Prisma Health - Upstate	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Kansas, Blood and Marrow Transplant Program	Kansas City	Kansas
United States	University of Wisconsin	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University Hospitals, Inc.	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	HCA Health Services of Oklahoma, Inc., University of OK	Oklahoma City	Oklahoma
United States	Nebraska Medicine	Omaha	Nebraska
United States	AdventHealth Orlando	Orlando	Florida
United States	Memorial Cancer Institute	Pembroke Pines	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona and Phoenix Children's Hospital	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University	Saint Louis	Missouri
United States	Texas Transplant Institute	San Antonio	Texas
United States	University of California San Francisco	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Stanford University	Stanford	California
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), National Marrow Donor Program

Country where clinical trial is conducted

United States, 

References & Publications (29)

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Mrozek K, Marcucci G, Nicolet D, Maharry KS, Becker H, Whitman SP, Metzeler KH, Schwind S, Wu YZ, Kohlschmidt J, Pettenati MJ, Heerema NA, Block AW, Patil SR, Baer MR, Kolitz JE, Moore JO, Carroll AJ, Stone RM, Larson RA, Bloomfield CD. Prognostic significance of the European LeukemiaNet standardized system for reporting cytogenetic and molecular alterations in adults with acute myeloid leukemia. J Clin Oncol. 2012 Dec 20;30(36):4515-23. doi: 10.1200/JCO.2012.43.4738. Epub 2012 Sep 17. — View Citation

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Muffly LS, Boulukos M, Swanson K, Kocherginsky M, Cerro PD, Schroeder L, Pape L, Extermann M, Van Besien K, Artz AS. Pilot study of comprehensive geriatric assessment (CGA) in allogeneic transplant: CGA captures a high prevalence of vulnerabilities in older transplant recipients. Biol Blood Marrow Transplant. 2013 Mar;19(3):429-34. doi: 10.1016/j.bbmt.2012.11.006. Epub 2012 Nov 15. — View Citation

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Raimondi R, Tosetto A, Oneto R, Cavazzina R, Rodeghiero F, Bacigalupo A, Fanin R, Rambaldi A, Bosi A. Validation of the Hematopoietic Cell Transplantation-Specific Comorbidity Index: a prospective, multicenter GITMO study. Blood. 2012 Aug 9;120(6):1327-33. doi: 10.1182/blood-2012-03-414573. Epub 2012 Jun 27. — View Citation

Rashidi A, Ebadi M, Colditz GA, DiPersio JF. Outcomes of Allogeneic Stem Cell Transplantation in Elderly Patients with Acute Myeloid Leukemia: A Systematic Review and Meta-analysis. Biol Blood Marrow Transplant. 2016 Apr;22(4):651-657. doi: 10.1016/j.bbmt.2015.10.019. Epub 2015 Oct 31. — View Citation

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	Overall survival	1 year
Secondary	Cumulative Incidence of Frailty	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
Secondary	Cumulative incidence of disability	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
Secondary	Cumulative incidence of admission to a skilled nursing facility	Cumulative incidence of admission to a skilled nursing facility	1 Year
Secondary	HRQOL using PROMIS domains	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
Secondary	Cumulative incidence of serious organ toxicity by day 100	Cumulative incidence of serious organ toxicity by day 100	100 Days
Secondary	Cumulative incidence of acute grade 2-4 GVHD	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
Secondary	Cumulative incidence of acute grade 2-4 GVHD	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
Secondary	Cumulative incidence of acute grade 2-4 GVHD	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
Secondary	Chronic GVHD requiring treatment with systemic immune-suppression	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
Secondary	Chronic GVHD requiring treatment with systemic immune-suppression	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
Secondary	Survival after development of acute grade 2-4 GVHD	Survival after development of acute grade 2-4 GVHD	1 year
Secondary	Cognitive decline at 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