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NCT Number: NCT05909501

Assessment of Geriatric Evaluations Impact on New AML Guidance

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.

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Key information

Conditions

AML, Adult Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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

  2. Evaluate baseline measures of physiologic age in relation to short term mortality

    Time frame: At 30 days and 60 days

  3. Evaluate baseline measures of physiologic age in relation to grade 3, 4, and 5 toxicities from treatment

    Time frame: At baseline, 14 days after treatment, 1 month after treatment

  4. Evaluate baseline measures of physiologic age in relation to complete remission

    Time frame: At baseline, 14 days after treatment, 1 month after treatment

  5. Compare baseline measurements to serial measurements to understand how physical function changes over time with treatment

    Time frame: At baseline, 14 days after treatment, 1 month after treatment

  6. Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity

    Time frame: At 30 days and 60 days

  7. Create a predictive pre-treatment screening tool

    Time frame: At baseline, 14 days after treatment, 1 month after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Lai, MD

CONTACT

[email protected]

2153600561

Colleen Redlinger

CONTACT

[email protected]

2152209693

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: AGE-ING

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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