Heart-Smart chemo: new infusion method aims to protect AML patients
NCT ID NCT02971397
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This early-stage study looked at whether giving two standard chemotherapy drugs (cytarabine and daunorubicin) in a different way could be safer for the heart in adults newly diagnosed with acute myeloid leukemia (AML). Researchers used heart MRI scans to monitor for damage. The goal was to see if this approach reduces heart side effects while still treating the cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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40 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Aug 2018
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British Classification \[FAB\], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 * Patients with ECHO EF \>= 45% within 28 days prior to registration * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Patients who have received prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; patients who have received a limited and short-term exposure of ATRA (all trans retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible * Patients receiving any other investigational agents * Patients with prolonged corrected QT (QTc) interval (\> 500 msec) determined by electrocardiogram (EKG) within 28 days prior to registration * Patients not suitable for cardiac MRI; contraindications include: * Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices * Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal * Allergy to gadolinium or other severe drug allergies * Claustrophobia * Congestive heart failure (New York Heart Association \[NYHA\] class III or IV) * Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to daunorubicin or cytarabine * Patients with documented central nervous system (CNS) involvement * Patients who are known to be human immunodeficiency virus (HIV) positive (+) may be eligible providing they meet all of the following additional criteria within 28 days prior to registration: * CD4 cells \>= 500/mm\^3 * Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or \< 25,000 copies HIV mRNA if not on cART * No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria are not eligible for this study * Patients with other uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study; breastfeeding should be discontinued prior to beginning treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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