Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
NCT ID: NCT03992352
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1229 participants
OBSERVATIONAL
2019-07-19
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Age 60+ with planned HCT for Hematologic Malignancy
Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments
Interventions
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Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments
Eligibility Criteria
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Inclusion Criteria
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
60 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Andrew Artz, MD, MS
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Mohamed Sorror, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Wael Saber, MD, MS
Role: STUDY_CHAIR
Medical College of Wisconsin/CIBMTR
Locations
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Mayo Clinic Arizona and Phoenix Children's Hospital
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Florida
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana Blood and Marrow Transplantation
Beech Grove, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas, Blood and Marrow Transplant Program
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Henry Ford Hospital Bone Marrow Transplant Program
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Nebraska Medicine
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, 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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Siedman Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State Universtiy
Columbus, Ohio, United States
HCA Health Services of Oklahoma, Inc., University of OK
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
West Virginia University Hospitals, Inc.
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Blaise D, Furst S, Crocchiolo R, El-Cheikh J, Granata A, Harbi S, Bouabdallah R, Devillier R, Bramanti S, Lemarie C, Picard C, Chabannon C, Weiller PJ, Faucher C, Mohty B, Vey N, Castagna L. Haploidentical T Cell-Replete Transplantation with Post-Transplantation Cyclophosphamide for Patients in or above the Sixth Decade of Age Compared with Allogeneic Hematopoietic Stem Cell Transplantation from an Human Leukocyte Antigen-Matched Related or Unrelated Donor. Biol Blood Marrow Transplant. 2016 Jan;22(1):119-24. doi: 10.1016/j.bbmt.2015.08.029. Epub 2015 Sep 1.
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Basak GW, Sánchez-Ortega I, Beohou E, et al. Allogeneic Hematopoietic Cell Transplantation in Elderly Patients Aged 65 and Older: A Retrospective Analysis By the Complications and Quality of Life Working Party of the EBMT. Blood. 2016;128:681-681.
Soto-Perez-de-Celis E, Li D, Yuan Y, Lau YM, Hurria A. Functional versus chronological age: geriatric assessments to guide decision making in older patients with cancer. Lancet Oncol. 2018 Jun;19(6):e305-e316. doi: 10.1016/S1470-2045(18)30348-6. Epub 2018 Jun 1.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specific comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005 Oct 15;106(8):2912-9. doi: 10.1182/blood-2005-05-2004. Epub 2005 Jun 30.
Sorror ML, Logan BR, Zhu X, Rizzo JD, Cooke KR, McCarthy PL, Ho VT, Horowitz MM, Pasquini MC. Prospective Validation of the Predictive Power of the Hematopoietic Cell Transplantation Comorbidity Index: A Center for International Blood and Marrow Transplant Research Study. Biol Blood Marrow Transplant. 2015 Aug;21(8):1479-87. doi: 10.1016/j.bbmt.2015.04.004. Epub 2015 Apr 7.
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.
Sorror ML, Storb RF, Sandmaier BM, Maziarz RT, Pulsipher MA, Maris MB, Bhatia S, Ostronoff F, Deeg HJ, Syrjala KL, Estey E, Maloney DG, Appelbaum FR, Martin PJ, Storer BE. Comorbidity-age index: a clinical measure of biologic age before allogeneic hematopoietic cell transplantation. J Clin Oncol. 2014 Oct 10;32(29):3249-56. doi: 10.1200/JCO.2013.53.8157. Epub 2014 Aug 25.
Muffly LS, Kocherginsky M, Stock W, Chu Q, Bishop MR, Godley LA, Kline J, Liu H, Odenike OM, Larson RA, van Besien K, Artz AS. Geriatric assessment to predict survival in older allogeneic hematopoietic cell transplantation recipients. Haematologica. 2014 Aug;99(8):1373-9. doi: 10.3324/haematol.2014.103655. Epub 2014 May 9.
Alousi AM, Le-Rademacher J, Saliba RM, Appelbaum FR, Artz A, Benjamin J, Devine SM, Kan F, Laughlin MJ, Lazarus HM, Liesveld J, Perales MA, Maziarz RT, Sabloff M, Waller EK, Eapen M, Champlin RE. Who is the better donor for older hematopoietic transplant recipients: an older-aged sibling or a young, matched unrelated volunteer? Blood. 2013 Mar 28;121(13):2567-73. doi: 10.1182/blood-2012-08-453860. Epub 2013 Jan 29.
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.
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Holmes HM, Des Bordes JK, Kebriaei P, Yennu S, Champlin RE, Giralt S, Mohile SG. Optimal screening for geriatric assessment in older allogeneic hematopoietic cell transplantation candidates. J Geriatr Oncol. 2014 Oct 1;5(4):422-30. doi: 10.1016/j.jgo.2014.04.004. Epub 2014 May 14.
Olin RL, Andreadis C, Martin TG, et al. Comprehensive Geriatric Assessment Identifies Significant Functional Impairments in Older Hematopoietic Cell Transplant Recipients. Biology of Blood and Marrow Transplant.20:S65-S66.
Wood WA, Deal AM, Reeve BB, Abernethy AP, Basch E, Mitchell SA, Shatten C, Hie Kim Y, Whitley J, Serody JS, Shea T, Battaglini C. Cardiopulmonary fitness in patients undergoing hematopoietic SCT: a pilot study. Bone Marrow Transplant. 2013 Oct;48(10):1342-9. doi: 10.1038/bmt.2013.58. Epub 2013 Apr 15.
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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BMT CTN 1704
Identifier Type: -
Identifier Source: org_study_id
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