Assessment of Geriatric Evaluations Impact on New AML Guidance

Recruiting

• Conditions: AML, Adult

• Registration Number: NCT05909501
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-18
• Study Start: 2023-10-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States