NCT03992352

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,229 (actual)
• Sponsor: Center for International Blood and Marrow Transplant Research · Network
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Age 60+ with planned HCT for Hematologic Malignancy	questionnaires, geriatric assessments

Timeline

• Start date: 2019-07-19
• Primary completion: 2023-05-29
• Completion: 2023-05-30
• First posted: 2019-06-20
• Last updated: 2024-02-06

Locations

50 sites across 1 country: United States