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Clinical Trial 20096
Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT03992352
Phase: N/A
Prinicipal Investigator: Asmita Mishra
Study Title
Composite Health Assessment Model for Older Adults: Applying Pre-transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation (CHARM)
Summary
This is a 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).
Objective
Primary Objective(s): 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. Secondary Objective(s): 1. Overall survival; 2. Cumulative Incidence of Frailty; 3. Cumulative incidence of disability; 4. Cumulative incidence of admission to a skilled nursing facility; 5. HRQOL; 6. Cumulative incidence of serious organ toxicity by day 100; 7. 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; 8. Survival after development of acute grade 2-4 GVHD; 9. Cognitive decline at day 100
Therapies
Medications
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