Assessment of Geriatric Evaluations Impact on New AML Guidance

AML, Adult Clinical Trial

— AGE-ING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909501
• Other study ID #: UPCC 11423
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Colleen Redlinger
• Phone: 2152209693
• Email: colleen.redlinger[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AML, Adult

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	At baseline, 14 days after treatment, 1 month after treatment
Primary	Evaluate baseline measures of physiologic age in relation to short term mortality		At 30 days and 60 days
Primary	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
Primary	Evaluate baseline measures of physiologic age in relation to complete remission		At baseline, 14 days after treatment, 1 month after treatment
Primary	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
Primary	Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity		At 30 days and 60 days
Primary	Create a predictive pre-treatment screening tool		At baseline, 14 days after treatment, 1 month after treatment