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

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

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.

Study Overview

• Status: Recruiting
• Conditions: AML, Adult

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Catherine Lai, MD; Phone Number: 2153600561; Email: Catherine.Lai@Pennmedicine.upenn.edu
• Study Contact Backup: Name: Colleen Redlinger; Phone Number: 2152209693; Email: colleen.redlinger@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center at University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the physician practices of Penn Medicine.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 14 days after treatment, 1 month after treatment
Evaluate baseline measures of physiologic age in relation to short term mortality		At 30 days and 60 days
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
Evaluate baseline measures of physiologic age in relation to complete remission		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		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		At 30 days and 60 days
Create a predictive pre-treatment screening tool		At baseline, 14 days after treatment, 1 month after treatment

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Catherine Lai, MD, Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: UPCC 11423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No