Cardioprotective Drugs for Acute Myeloid Leukemia
(AML 001 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if taking beta blockers and ACE inhibitors can prevent heart damage in AML patients receiving daunorubicin chemotherapy. These medications help protect the heart by reducing stress and preventing damage. The study will compare heart health and quality of life between those who take these medications and those who do not.
Will I have to stop taking my current medications?
If you are currently using any beta blockers, ACE inhibitors, or angiotensin II receptor blockers, you will need to stop taking them before joining this trial. The trial does not specify about other medications, so it's best to discuss your current medications with the study team.
Is it safe to use cardioprotective drugs like ACE inhibitors and beta-blockers in humans?
How is the cardioprotective drug treatment for acute myeloid leukemia different from other treatments?
This treatment is unique because it uses beta blockers and ACE inhibitors, which are typically used to protect the heart from damage, to prevent heart problems caused by chemotherapy in acute myeloid leukemia patients. Unlike traditional cancer treatments that focus solely on attacking cancer cells, this approach aims to protect the heart from the harmful side effects of chemotherapy.14567
What data supports the effectiveness of cardioprotective drugs for preventing heart damage in patients with acute myeloid leukemia?
Research shows that cardioprotective drugs like beta-blockers and ACE inhibitors can help prevent heart damage caused by certain cancer treatments. These drugs have been found to reduce heart problems in patients receiving chemotherapy, which suggests they might also help protect the heart in acute myeloid leukemia patients.34678
Who Is on the Research Team?
Michael Keng, MD
Principal Investigator
UVA
Are You a Good Fit for This Trial?
Adults over 18 with newly-diagnosed Acute Myeloid Leukemia (AML) who are about to start or have just started induction therapy without anthracycline can join. They must be able to take oral meds, have good organ function, and an ejection fraction ≥ 50%. Women of childbearing age and men must use contraception. Can't join if already using heart meds like beta blockers or ACEi, have severe illnesses/heart issues, pregnant/lactating women, or those with certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction therapy for AML, including daunorubicin and potentially beta blocker and ACE inhibitor for cardioprotection
Consolidation Treatment
Continuation of AML treatment and cardioprotective measures, with regular assessments via ECG/EKG and echocardiogram
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of heart function and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Cardioprotection
Cardioprotection is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor