Recruiting

Observational Study

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT05909501

Conditions

AML, Adult

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

AML, Adult

Study ID

NCT05909501

Start date

Oct 25, 2023

Status verified date

Aug, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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. [ 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 ]

Central Contacts and Locations

Central contacts

Colleen Redlinger

2152209693colleen.redlinger@pennmedicine.upenn.edu

Catherine Lai, MD

2153600561Catherine.Lai@Pennmedicine.upenn.edu

Locations

Abramson Cancer Center at University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2025-08-07.