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

Sponsor

Abramson Cancer Center at Penn Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05909501

Collaborator

Bristol-Myers Squibb (Industry)

100

Enrollment

Location

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML, Adult

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Outcome Measures

Primary Outcome Measures

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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center at Penn Medicine
Bristol-Myers Squibb

Investigators

Principal Investigator: Catherine Lai, MD, Abramson Cancer Center at Penn Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center at Penn Medicine

ClinicalTrials.gov Identifier:

NCT05909501

Other Study ID Numbers:

UPCC 11423

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 18, 2023