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Hematologic MalignancyBMT CTN 1704NCT03992352

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

An observational study of Hematologic Malignancy, run by Center for International Blood and Marrow Transplant Research at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hematologic Malignancy
What is being tested?
Age 60+ with planned HCT for Hematologic Malignancy
How many people
1,229 participants
Where
50 sitesUnited States
Study dates
19 Jul 2019to 30 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 1. Prior allogeneic HCT

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Indiana Blood and Marrow Transplantation

    Beech Grove, Indiana, 46107

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Chicago Medicine

    Chicago, Illinois, 60637

  • Siedman Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State Universtiy

    Columbus, Ohio, 43210

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Henry Ford Hospital Bone Marrow Transplant Program

    Detroit, Michigan, 48202

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32610

  • Prisma Health - Upstate

    Greenville, South Carolina, 29615

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Kansas, Blood and Marrow Transplant Program

    Kansas City, Kansas, 66160

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • West Virginia University Hospitals, Inc.

    Morgantown, West Virginia, 26506

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

  • Mount Sinai Medical Center

    New York, New York, 10029

  • New York Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

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

    Oklahoma City, Oklahoma, 73104

  • Nebraska Medicine

    Omaha, Nebraska, 68198

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Arizona and Phoenix Children's Hospital

    Phoenix, Arizona, 85054

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • University of California San Francisco

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Washington University

    St Louis, Missouri, 63130

  • Stanford University

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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)

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).

Read the 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.

Being tested
Age 60+ with planned HCT for Hematologic Malignancy
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Age 60+ with planned HCT for Hematologic MalignancyDiagnostic test

    questionnaires, geriatric assessments

Study groups in NCT03992352
Study groupRoleWhat they receive
Age 60+ with planned HCT for Hematologic MalignancySubjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
Receives: Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (13)

  1. Overall survival

    Overall survival

    Measured: 1 year

  2. 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'.

    Measured: 1 Year

  3. 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.

    Measured: 1 Year

  4. Cumulative incidence of admission to a skilled nursing facility

    Cumulative incidence of admission to a skilled nursing facility

    Measured: 1 Year

  5. 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.

    Measured: 1 Year

  6. Cumulative incidence of serious organ toxicity by day 100

    Cumulative incidence of serious organ toxicity by day 100

    Measured: 100 Days

  7. 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

    Measured: 100 days

  8. 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

    Measured: 6 months

  9. 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

    Measured: 1 year

  10. 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

    Measured: 6 months

  11. 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

    Measured: 1 year

  12. Survival after development of acute grade 2-4 GVHD

    Survival after development of acute grade 2-4 GVHD

    Measured: 1 year

  13. 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.

    Measured: Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start19 Jul 2019
  3. Primary completion29 May 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03992352
Sponsor's protocol ID
BMT CTN 1704
Other IDs
5U24HL138660-02
Acronym
BMT CTN 1704
Status last verified
Feb 2024
First submitted
18 Jun 2019
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22705801

  • 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.

    PubMed 25445636

  • 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.

    PubMed 22383796

  • 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.

    PubMed 22987078

  • 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.

    PubMed 27624670

  • 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.

    PubMed 26529178

  • 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.

    PubMed 26527780

  • 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.

  • 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.

    PubMed 26341397

  • 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.

    PubMed 26261255

  • 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.

    PubMed 26415559

  • 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.

    PubMed 29893262

  • 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.

    PubMed 3558716

  • 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.

    PubMed 15994282

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Malignancy, run by Center for International Blood and Marrow Transplant Research at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

One Year Non-Relapse Mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03992352, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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