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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24HL138660-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| 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 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 60+ with planned HCT for Hematologic Malignancy | Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Age 60+ with planned HCT for Hematologic Malignancy | Diagnostic Test | questionnaires, geriatric assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival | 1 year |
| 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'. |
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Inclusion Criteria:
Exclusion Criteria:
1. Prior allogeneic HCT
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Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona and Phoenix Children's Hospital | Phoenix | Arizona | 85054 | United States | ||
| City of Hope National Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22705801 | Background | Pidala J, Craig BM, Lee SJ, Majhail N, Quinn G, Anasetti C. Practice variation in physician referral for allogeneic hematopoietic cell transplantation. Bone Marrow Transplant. 2013 Jan;48(1):63-7. doi: 10.1038/bmt.2012.95. Epub 2012 Jun 18. | |
| 25445636 | Background | Appelbaum FR, Anasetti C, Antin JH, Atkins H, Davies S, Devine S, Giralt S, Heslop H, Laport G, Lee SJ, Logan B, Pasquini M, Pulsipher M, Stadtmauer E, Wingard JR, Horowitz MM. Blood and marrow transplant clinical trials network state of the Science Symposium 2014. Biol Blood Marrow Transplant. 2015 Feb;21(2):202-24. doi: 10.1016/j.bbmt.2014.10.003. Epub 2014 Oct 15. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2021 | Jan 25, 2023 |
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| NETWORK |
| National Marrow Donor Program | OTHER |
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| 1 Year |
| 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 |
| Cumulative incidence of admission to a skilled nursing facility | Cumulative incidence of admission to a skilled nursing facility | 1 Year |
| 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 |
| Cumulative incidence of serious organ toxicity by day 100 | Cumulative incidence of serious organ toxicity by day 100 | 100 Days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Survival after development of acute grade 2-4 GVHD | Survival after development of acute grade 2-4 GVHD | 1 year |
| 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 |
| Duarte |
| California |
| 91010 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| AdventHealth Orlando | Orlando | Florida | 32804 | United States |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Indiana Blood and Marrow Transplantation | Beech Grove | Indiana | 46107 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Kansas, Blood and Marrow Transplant Program | Kansas City | Kansas | 66160 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital Bone Marrow Transplant Program | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Nebraska Medicine | Omaha | Nebraska | 68198 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| New York Presbyterian Hospital/Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Siedman Cancer Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State Universtiy | Columbus | Ohio | 43210 | United States |
| HCA Health Services of Oklahoma, Inc., University of OK | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Prisma Health - Upstate | Greenville | South Carolina | 29615 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth | Richmond | Virginia | 23298 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| West Virginia University Hospitals, Inc. | Morgantown | West Virginia | 26506 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| 22383796 | Background | Juliusson G, Lazarevic V, Horstedt AS, Hagberg O, Hoglund M; Swedish Acute Leukemia Registry Group. Acute myeloid leukemia in the real world: why population-based registries are needed. Blood. 2012 Apr 26;119(17):3890-9. doi: 10.1182/blood-2011-12-379008. Epub 2012 Mar 1. |
| 22987078 | Background | 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. |
| 27624670 | Background | Burnett AK, Russell NH, Hills RK, Kell J, Nielsen OJ, Dennis M, Cahalin P, Pocock C, Ali S, Burns S, Freeman S, Milligan D, Clark RE. A comparison of clofarabine with ara-C, each in combination with daunorubicin as induction treatment in older patients with acute myeloid leukaemia. Leukemia. 2017 Feb;31(2):310-317. doi: 10.1038/leu.2016.225. Epub 2016 Sep 2. |
| 26529178 | Background | 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. |
| 26527780 | Background | Devine SM, Owzar K, Blum W, Mulkey F, Stone RM, Hsu JW, Champlin RE, Chen YB, Vij R, Slack J, Soiffer RJ, Larson RA, Shea TC, Hars V, Sibley AB, Giralt S, Carter S, Horowitz MM, Linker C, Alyea EP. Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. J Clin Oncol. 2015 Dec 10;33(35):4167-75. doi: 10.1200/JCO.2015.62.7273. Epub 2015 Nov 2. |
| Background | Muffly L, Pasquini MC, Martens M, et al. Increasing Use of Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients Age 70 Years and Older: A CIBMTR Study of Trends and Outcomes. Biology of Blood and Marrow Transplant.22:S68-S69. |
| 26341397 | Background | 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. |
| 26261255 | Background | Kasamon YL, Bolanos-Meade J, Prince GT, Tsai HL, McCurdy SR, Kanakry JA, Rosner GL, Brodsky RA, Perica K, Smith BD, Gladstone DE, Swinnen LJ, Showel MM, Matsui WH, Huff CA, Borrello I, Pratz KW, McDevitt MA, Gojo I, Dezern AE, Shanbhag S, Levis MJ, Luznik L, Ambinder RF, Fuchs EJ, Jones RJ. Outcomes of Nonmyeloablative HLA-Haploidentical Blood or Marrow Transplantation With High-Dose Post-Transplantation Cyclophosphamide in Older Adults. J Clin Oncol. 2015 Oct 1;33(28):3152-61. doi: 10.1200/JCO.2014.60.4777. Epub 2015 Aug 10. |
| 26415559 | Background | Sandhu KS, Brunstein C, DeFor T, Bejanyan N, Arora M, Warlick E, Weisdorf D, Ustun C. Umbilical Cord Blood Transplantation Outcomes in Acute Myelogenous Leukemia/Myelodysplastic Syndrome Patients Aged >/=70 Years. Biol Blood Marrow Transplant. 2016 Feb;22(2):390-393. doi: 10.1016/j.bbmt.2015.09.020. Epub 2015 Sep 28. |
| Background | 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. |
| 29893262 | Background | 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. |
| 3558716 | Background | 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. |
| 15994282 | Background | 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. |
| 25862591 | Background | 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. |
| 22740454 | Background | 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. |
| 25154831 | Background | 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. |
| 24816237 | Background | 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. |
| 23361908 | Background | 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. |
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| 21357782 | Background | Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, Schmieder L, Ansari R, Tew WP, Weckstein D, Kirshner J, Togawa K, Hansen K, Katheria V, Stone R, Galinsky I, Postiglione J, Cohen HJ. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985. Epub 2011 Feb 28. |
| 27185838 | Background | Hurria A, Mohile S, Gajra A, Klepin H, Muss H, Chapman A, Feng T, Smith D, Sun CL, De Glas N, Cohen HJ, Katheria V, Doan C, Zavala L, Levi A, Akiba C, Tew WP. Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer. J Clin Oncol. 2016 Jul 10;34(20):2366-71. doi: 10.1200/JCO.2015.65.4327. Epub 2016 May 16. |
| 24835889 | Background | 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. |
| Background | 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. |
| 23584437 | Background | 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. |
| 26446235 | Background | Jones LW, Devlin SM, Maloy MA, Wood WA, Tuohy S, Espiritu N, Aquino J, Kendig T, Michalski MG, Gyurkocza B, Schaffer WL, Ali B, Giralt S, Jakubowski AA. Prognostic Importance of Pretransplant Functional Capacity After Allogeneic Hematopoietic Cell Transplantation. Oncologist. 2015 Nov;20(11):1290-7. doi: 10.1634/theoncologist.2015-0200. Epub 2015 Oct 7. |
| 11253156 | Background | Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. |
| 41269781 | Derived | Artz AS, Logan B, Saber W, Geller N, Bellach A, Kou J, Wood WA, McCarty JM, Knight TG, Runaas L, Johnston L, Walston J, Nakamura R, Mishra A, Uberti J, Dahi PB, Saultz JN, McCurdy SR, Morris L, Imus P, Hogan WJ, Nadiminti K, Bhatt VR, Olin R, Maakaron J, Sobecks R, Wall S, 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. 2026 Mar 10;10(5):1657-1669. doi: 10.1182/bloodadvances.2025018340. |
| 40101246 | 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. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
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