RecruitingObservational

AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study

NCT ID: NCT05909501Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2025-08-07

Summary

The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.

Outcome measures

Primary

Evaluate physiologic age using baseline measures of physical function, depression, cognition, frailty, and PROs in newly diagnosed AML patients receiving intensive and non-intensive treatment in relation to overall survival at 1 year.
Short physical performance battery (SPPB), geriatric depression scale (GDS), mini-COG, patient reported outcomes of physical function, fatigue, depression, cognition, anxiety
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to short term mortality
Time frame: At 30 days and 60 days
Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to complete remission
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment
Time frame: At baseline, 14 days after treatment, 1 month after treatment
Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity
Time frame: At 30 days and 60 days
Create a predictive pre-treatment screening tool
Time frame: At baseline, 14 days after treatment, 1 month after treatment

Eligibility criteria

Sex: AllAge: 50 Years and olderHealthy volunteers: No

Inclusion Criteria: * AML diagnosis by peripheral flow cytometry and/or bone marrow aspirate and biopsy * New diagnosis being considered for new line of treatment * Age ≥ 50 years. * Performance status 0,1, and 2 Exclusion Criteria: * Inability to understand or unable to sign a written informed consent * Unable to fill out questionnaires on their own and/or do not have someone to help complete them

Study locations (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting