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

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT03992352

5U24HL138660-02 (U.S. NIH Grant/Contract)

BMT CTN 1704

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,229 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,229 participants in 1 patient group

Age 60+ with planned HCT for Hematologic Malignancy

Description:

Subjects 60 years or older with a planned allogeneic transplantation for a hematologic malignancy.

Treatment:

Diagnostic Test: Age 60+ with planned HCT for Hematologic Malignancy