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

  • Observational
  • Recruiting
  • NCT03992352
Eligibility Details Visit Clinicaltrials.gov

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)

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).

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.

Gender
All

Age Group
60 Years and up

Accepting 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

At a Glance

National Government IDNCT03992352

IRB#CIRB19-0874

Lead SponsorCenter for International Blood and Marrow Transplant Research

Lead PhysicianSatyajit Kosuri

Collaborator(s)N/A

EligibilityAll
60 Years and up
Recruiting