Hematologic Malignancy
Conditions
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.
Interventions
DIAGNOSTIC_TESTAge 60+ with planned HCT for Hematologic Malignancy
questionnaires, geriatric assessments
Sponsors
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
Center for International Blood and Marrow Transplant Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One Year Non-Relapse Mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Incidence of Frailty | 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 | 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 | 1 Year | Cumulative incidence of admission to a skilled nursing facility |
| HRQOL using PROMIS domains | 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. |
| Overall survival | 1 year | Overall survival |
| Cumulative incidence of acute grade 2-4 GVHD | 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 |
| Chronic GVHD requiring treatment with systemic immune-suppression | 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 |
| Survival after development of acute grade 2-4 GVHD | 1 year | Survival after development of acute grade 2-4 GVHD |
| Cognitive decline at day 100 | 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. |
| Cumulative incidence of serious organ toxicity by day 100 | 100 Days | Cumulative incidence of serious organ toxicity by day 100 |
Countries
United States
Outcome results
None listed