RECRUITING

Cardioprotection in AML

Conditions

AML Acute Myeloid Leukemia cardioprotection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often used (and are FDA approved) to treat the type of damage to the heart caused by anthracyclines. They have also been used in some populations to prevent this type of heart damage. In this study, participants will be randomly assigned to either preventively take a beta blocker and ACEi or not to receive these. The primary purpose of the study is to look at how often people in each group develop this type of heart damage. The study investigators will also collect data about your quality of life and other changes in your heart function. Frequency and severity of anthracycline-induced cardiotoxicity among patients receiving acute myeloid leukemia (AML) chemotherapy is unknown. We hypothesize that up-titrating study agents to maximum tolerated dosage at the time of induction (starting treatment for AML) will prevent the development of systolic dysfunction as determined on serial echocardiography.

Official Title

Phase II Trial of Cardioprotective Prophylaxis With Combination of Beta Blocker and Angiotensin-Converting Enzyme Inhibitors During Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia

Quick Facts

Study Start:2022-03-04

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04977180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Signed informed consent obtained prior to conducting any study-specific screening procedures. 2. Willing and able to understand the nature of this study and to comply with both the study as well as follow-up procedures for the duration of the study. 3. Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML) 4. ECOG performance status must be ≤ 2 5. Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered. 6. Adequate organ function as evidenced by the following laboratory findings: 1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert's Syndrome 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN 3. Creatinine clearance \> 60 mL/min 7. Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen 8. Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy 9. For females of reproductive potential and males: Agree to abstain from sexual activity or use reliable contraception while undergoing treatment with chemotherapy and/or ACE inhibitors due to the risk of teratogenicity to the fetus.	1. Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening. 2. Uncontrolled, intercurrent illnesses including but not limited to symptomatic unstable angina pectoris, cardiac arrhythmias not well controlled with medications, myocardial infarction in the 6 months preceding registration or psychiatric illness/social situations that would limit compliance with study requirements as determined by the study personnel, all at the discretion of the treating oncologist. 3. Patient receiving concurrent investigational agents, or those who have received an investigational agent within one week of registration. * The side effects of the drug are well studied and well known AND * The drug is not known to be cardioprotective or cardiotoxic 4. Females who are pregnant or lactating. 5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or study outcomes. 6. Active, untreated and/or severe infections as determined by the treating oncologist. 7. History of hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low-dose prednisone (≤ 5mg) or calcineurin inhibitors within the four weeks preceding registration 9. Congestive heart failure as clinically diagnosed by treating oncologist at the time of presentation for induction chemotherapy, or documented diagnosed by a previous physician. 10. History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines 11. Significant liver disease, including cirrhosis or history of transplant or hepatorenal syndrome) 12. Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy. 13. Baseline resting systolic blood pressure \< 95mmHg at presentation for induction chemotherapy. 14. Documented allergy to beta blockers or ACE inhibitors.

Inclusion Criteria

Exclusion Criteria

1. Signed informed consent obtained prior to conducting any study-specific screening procedures.
2. Willing and able to understand the nature of this study and to comply with both the study as well as follow-up procedures for the duration of the study.
3. Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML)
4. ECOG performance status must be ≤ 2
5. Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered.
6. Adequate organ function as evidenced by the following laboratory findings:
1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert's Syndrome
2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
3. Creatinine clearance \> 60 mL/min
7. Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen
8. Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy
9. For females of reproductive potential and males: Agree to abstain from sexual activity or use reliable contraception while undergoing treatment with chemotherapy and/or ACE inhibitors due to the risk of teratogenicity to the fetus.

1. Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening.
2. Uncontrolled, intercurrent illnesses including but not limited to symptomatic unstable angina pectoris, cardiac arrhythmias not well controlled with medications, myocardial infarction in the 6 months preceding registration or psychiatric illness/social situations that would limit compliance with study requirements as determined by the study personnel, all at the discretion of the treating oncologist.
3. Patient receiving concurrent investigational agents, or those who have received an investigational agent within one week of registration.
* The side effects of the drug are well studied and well known AND
* The drug is not known to be cardioprotective or cardiotoxic
4. Females who are pregnant or lactating.
5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or study outcomes.
6. Active, untreated and/or severe infections as determined by the treating oncologist.
7. History of hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low-dose prednisone (≤ 5mg) or calcineurin inhibitors within the four weeks preceding registration
9. Congestive heart failure as clinically diagnosed by treating oncologist at the time of presentation for induction chemotherapy, or documented diagnosed by a previous physician.
10. History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines
11. Significant liver disease, including cirrhosis or history of transplant or hepatorenal syndrome)
12. Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy.
13. Baseline resting systolic blood pressure \< 95mmHg at presentation for induction chemotherapy.
14. Documented allergy to beta blockers or ACE inhibitors.

Contacts and Locations

Study Contact

Cory Caldwell, RN

CONTACT

434-297-4182

CJC2P@uvahealth.org

Avani Hopkins, RN

CONTACT

AJH7JQE@uvahealth.org

Principal Investigator

Michael Keng, MD

PRINCIPAL_INVESTIGATOR

UVA

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

Michael Keng, MD, PRINCIPAL_INVESTIGATOR, UVA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-04

Study Completion Date2028-09

Study Record Updates

Study Start Date2022-03-04

Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

cardioprotection

Additional Relevant MeSH Terms

AML
Acute Myeloid Leukemia