AML, Adult Clinical Trial
— AGE-INGOfficial title:
AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study
NCT number | NCT05909501 |
Other study ID # | UPCC 11423 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 25, 2023 |
Est. completion date | July 1, 2025 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Evaluate baseline measures of physiologic age in relation to short term mortality | At 30 days and 60 days | ||
Primary | 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 | ||
Primary | Evaluate baseline measures of physiologic age in relation to complete remission | At baseline, 14 days after treatment, 1 month after treatment | ||
Primary | 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 | ||
Primary | Evaluate albumin as a biomarker predictor of clinical outcomes of short term mortality, 1 year OS and toxicity | At 30 days and 60 days | ||
Primary | Create a predictive pre-treatment screening tool | At baseline, 14 days after treatment, 1 month after treatment |
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