Assessment of Geriatric Evaluations Impact on New AML Guidance

NCT05909501 | Recruiting

• 1 other identifier: UPCC 11423
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Catherine Lai, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen Redlinger

CONTACT

2152209693; colleen.redlinger@pennmedicine.upenn.edu

Catherine Lai, MD

CONTACT

2153600561; Catherine.Lai@Pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 18, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

US (1)