Assessment of Geriatric Evaluations Impact on New AML Guidance
ConditionAML, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants will be recruited from the physician practices of Penn Medicine.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Short physical performance battery (SPPB), geriatric depression scale (GDS), mini-COG, patient reported outcomes of physical function, fatigue, depression, cognition, anxiety
Time frame
At baseline, 14 days after treatment, 1 month after treatment2
Evaluate baseline measures of physiologic age in relation to short term mortality
Time frame
At 30 days and 60 days3
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 treatment4
Evaluate baseline measures of physiologic age in relation to complete remission
Time frame
At baseline, 14 days after treatment, 1 month after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov