This study is in progress, not accepting new patients

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

a study on Hematologic Malignancy

Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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).

Official Title

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)

Details

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.

Keywords

Hematologic Malignancy Hematologic Neoplasms Age 60+ with planned HCT for Hematologic Malignancy

Eligibility

You can join if…

Open to people ages 60 years and up

  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

You CAN'T join if...

  1. Prior allogeneic HCT

Locations

  • University of California San Francisco
    San Francisco California 94143 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT03992352
Study Type
Observational
Participants
At least 1229 people participating
Last Updated