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Clinical Trial 20096

Cancer Type: Malignant Hematology
Study Type: Other
NCT#: NCT03992352

Phase: N/A
Principal Investigator: Mishra, Asmita

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Study Title

Composite Health Risk Assessment Model for Older Adults: Applying Pre-transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplant (CHARM)


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).


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




Inclusion Criteria

  • 60 years of age or older
  • 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.

  • Exclusion Criteria

  • Prior allogeneic Hematopoietic Stem Cell Transplant

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