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出境医 / 临床实验 / Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
Composite Health Assessment Risk Model (CHARM) for Older Adults (BMT CTN 1704)
Study Description
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).
| Condition or disease | Intervention/treatment |
|---|---|
| Hematologic Malignancy | Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy |
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.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Actual Study Start Date : | July 19, 2019 |
| Estimated Primary Completion Date : | July 31, 2022 |
| Estimated Study Completion Date : | September 30, 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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
questionnaires, geriatric assessments
|
Outcome Measures
Primary Outcome Measures :
- One Year Non-Relapse Mortality [ Time Frame: 1 year ]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.
Secondary Outcome Measures :
- Overall survival [ Time Frame: 1 year ]Overall survival
- Cumulative Incidence of Frailty [ Time Frame: 1 Year ]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'.
- Cumulative incidence of disability [ Time Frame: 1 Year ]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.
- Cumulative incidence of admission to a skilled nursing facility [ Time Frame: 1 Year ]Cumulative incidence of admission to a skilled nursing facility
- HRQOL using PROMIS domains [ Time Frame: 1 Year ]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.
- Cumulative incidence of serious organ toxicity by day 100 [ Time Frame: 100 Days ]Cumulative incidence of serious organ toxicity by day 100
- Cumulative incidence of acute grade 2-4 GVHD [ Time Frame: 100 days ]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
- Cumulative incidence of acute grade 2-4 GVHD [ Time Frame: 6 months ]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
- Cumulative incidence of acute grade 2-4 GVHD [ Time Frame: 1 year ]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
- Chronic GVHD requiring treatment with systemic immune-suppression [ Time Frame: 6 months ]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
- Chronic GVHD requiring treatment with systemic immune-suppression [ Time Frame: 1 year ]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
- Survival after development of acute grade 2-4 GVHD [ Time Frame: 1 year ]Survival after development of acute grade 2-4 GVHD
- Cognitive decline at day 100 [ Time Frame: 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.
Eligibility Criteria
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Prior allogeneic HCT
Contacts and Locations
Contacts
| Contact: Kelsey Schertz, MPH | 763-406-4135 | kschertz@nmdp.org | |
| Contact: Erin Leckrone | 763-406-5124 | eleckron@nmdp.org |
Locations
Show 36 study locations
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Blood and Marrow Transplant Clinical Trials Network
National Marrow Donor Program
Investigators
| Principal Investigator: | Andrew Artz, MD, MS | City of Hope Medical Center | |
| Principal Investigator: | Mohamed Sorror, MD, MSc | Fred Hutchinson Cancer Research Center | |
| Study Chair: | Wael Saber, MD, MS | Medical College of Wisconsin/CIBMTR |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 18, 2019 | |||||||||
| First Posted Date | June 20, 2019 | |||||||||
| Last Update Posted Date | May 12, 2021 | |||||||||
| Actual Study Start Date | July 19, 2019 | |||||||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
One Year Non-Relapse Mortality [ Time Frame: 1 year ] 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.
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| Original Primary Outcome Measures |
One Year Non-Relapse Mortality [ Time Frame: 1 year ] 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.
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Composite Health Assessment Risk Model (CHARM) for Older Adults | |||||||||
| 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 | |||||||||
| 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). | |||||||||
| 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. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Probability Sample | |||||||||
| Study Population | Age 60+ receiving first allogeneic Hematopoetic Cell Transplantation for a hematologic malignancy | |||||||||
| Condition | Hematologic Malignancy | |||||||||
| Intervention | Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments
|
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| Study Groups/Cohorts | Age 60+ with planned HCT for Hematologic Malignancy
Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.
Intervention: Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
1100 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | September 30, 2022 | |||||||||
| Estimated Primary Completion Date | July 31, 2022 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: 1. Prior allogeneic HCT |
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| Sex/Gender |
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| Ages | 60 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03992352 | |||||||||
| Other Study ID Numbers | BMT CTN 1704 5U24HL138660-02 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Center for International Blood and Marrow Transplant Research | |||||||||
| Study Sponsor | Center for International Blood and Marrow Transplant Research | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Center for International Blood and Marrow Transplant Research | |||||||||
| Verification Date | May 2021 | |||||||||
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