AML, Adult
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Abramson Cancer Center at Penn Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Contacts
Primary ContactColleen Redlinger
Backup ContactCatherine Lai, MD
Outcome results
None listed