Newly Diagnosed Acute Myeloid Leukemia (AML)AML/HMANCT07851012
Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients
An observational study of Newly Diagnosed Acute Myeloid Leukemia (AML), run by Assiut University.
Trial summary
The aim of this study is to evaluate and compare the cardiotoxic effects associated with anthracycline-based induction chemotherapy and those receiving a Venetoclax or HMA regimens after four cycles of chemotherpy in patients with newly diagnosed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Newly Diagnosed Acute Myeloid Leukemia (AML)
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2026to 14 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and / or Hypomethylating Agent based regimens * Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
Who may be able to join
- Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and / or Hypomethylating Agent based regimens
- Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
- Patient provided written, informed consent.
Who cannot join
- Prior history of anthracycline or venetoclax_HMAs exposure.
- Pre-existing severe structural heart disease (e.g., severe valvular heart disease, ischemic cardiomyopathy, basal LVEF <50%).
- Persistent hemodynamically unstable arrhythmias.
- Poor acoustic windows making reliable 2D-STE tracking impossible.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients: Anthracycline-Based Induction Versus Venetoclax - Hypomethylating Agent RegimensJ
The aim of this study is to evaluate and compare the cardiotoxic effects associated with anthracycline-based induction chemotherapy and those receiving a Venetoclax or HMA regimens after four cycles of chemotherpy in patients with newly diagnosed acute myeloid leukemia.
Read the detailed description
Acute Myeloid Leukemia (AML) is an aggressive hematologic malignancy that necessitates immediate risk assessment and therapeutic intervention.
Acute myeloid leukemia (AML) is a rapidly progressing myeloid neoplasm characterized by the clonal expansion of immature myeloid-derived cells, known as blasts, in the peripheral blood and bone marrow. This expansion results in ineffective erythropoiesis and megakaryopoiesis, clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This leads to inadequate production of red blood cells and platelets.
Although the administration of multiagent induction chemotherapy can induce complete remission, allogeneic stem cell transplantation is the only established curative therapy. Despite advancements in therapeutic approaches, prognosis remains suboptimal, especially among the older populations.
Intensive induction chemotherapy containing cytarabine and an anthracycline has been part of the upfront and salvage treatment of AML for decades. Unfortunately, anthracyclines are considered the principal culprit drugs behind chemotherapy-induced cardiotoxicity. Anthracycline-induced cardiotoxicity (AIC) is classified into acute and chronic based on the time of onset, with chronic cardiotoxicity potentially occurring within a year or several years after the completion of anthracycline treatment. The cardiotoxicity is almost exclusively chronic, and only a small proportion is acute and typically reversible upon discontinuation of anthracycline treatment.
In contrast, Venetoclax, a B-cell leukemia/lymphoma-2 inhibitor, is a promising novel drug that is currently used with hypomethylating agents (HMAs) like Azacitidine or Decitabine in older patients with acute myeloid leukemia (AML). These patients are known to have a high burden of cardiovascular (CV) risk factors and comorbidities.
The toxicity profile of Venetoclax includes neutropenia, gastrointestinal issues, and diarrhea, while there is growing concern regarding its potential cardiotoxicity in patients undergoing treatment for Acute Myeloid Leukemia. High doses or prolonged use of Venetoclax may lead to serious cardiac complications, such as myocardial infarction, new-onset atrial fibrillation, and even sudden cardiac death.
Traditionally, cardiotoxicity monitoring is conducted via serial measurements of Left Ventricular Ejection Fraction (LVEF) through standard echocardiography. However, LVEF is an insensitive and late indicator; a drop in LVEF occurs only after a significant loss of myocardial reserve has already taken place, often rendering the damage irreversible.Speckle Tracking Echocardiography (STE) is an advanced, non-invasive imaging modality that quantifies myocardial deformation by tracking acoustic markers (speckles) frame-by-frame. It measures Global Longitudinal Strain (GLS), which can detect subclinical cardiotoxicity (early micro-vascular and myofibrillar dysfunction) long before any detectable decline in conventional LVEF manifests.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cardiotoxcicity between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / or HMA regimens after four cycles of chemotherpy
.To evaluate and compare the incidence of subclinical cardiotoxicity (defined as a relative reduction in Left Ventricular GLS >15 % from baseline) between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / or HMA regimens after four cycles of chemotherpy by speckle tracking echocardiographic assesment which measure Global longitudinal strain also by ECG,High sensitive Troponin and CKMb
Measured: 2 years
Secondary outcomes (2)
Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups.
Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups by measurement of Left ventricular ejection fraction by M-Mode
Measured: 2 years
Assesment of Organ Dysfunction
Measurement of CBC, Urea, Creatinine, AST, ALT, serum Albumin, Direct bilirubin and Total bilirubin
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start14 Oct 2026 (estimated)
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Hussein Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851012
- Sponsor's protocol ID
- 04-2026-100534
- Acronym
- AML/HMA
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiotoxicity in Newly Diagnosed Acute Myeloid Leukemia Patients: Anthracycline-Based Induction Versus Venetoclax - Hypomethylating Agent RegimensJ
- ClinicalTrials.gov ID
- NCT07851012
- Acronym / sponsor ID
- AML/HMA / 04-2026-100534
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate and compare the cardiotoxic effects associated with anthracycline-based induction chemotherapy and those receiving a Venetoclax or HMA regimens after four cycles of chemotherpy in patients with newly diagnosed acute myeloid leukemia.
Detailed description
Acute Myeloid Leukemia (AML) is an aggressive hematologic malignancy that necessitates immediate risk assessment and therapeutic intervention.
Acute myeloid leukemia (AML) is a rapidly progressing myeloid neoplasm characterized by the clonal expansion of immature myeloid-derived cells, known as blasts, in the peripheral blood and bone marrow. This expansion results in ineffective erythropoiesis and megakaryopoiesis, clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This leads to inadequate production of red blood cells and platelets.
Although the administration of multiagent induction chemotherapy can induce complete remission, allogeneic stem cell transplantation is the only established curative therapy. Despite advancements in therapeutic approaches, prognosis remains suboptimal, especially among the older populations.
Intensive induction chemotherapy containing cytarabine and an anthracycline has been part of the upfront and salvage treatment of AML for decades. Unfortunately, anthracyclines are considered the principal culprit drugs behind chemotherapy-induced cardiotoxicity. Anthracycline-induced cardiotoxicity (AIC) is classified into acute and chronic based on the time of onset, with chronic cardiotoxicity potentially occurring within a year or several years after the completion of anthracycline treatment. The cardiotoxicity is almost exclusively chronic, and only a small proportion is acute and typically reversible upon discontinuation of anthracycline treatment.
In contrast, Venetoclax, a B-cell leukemia/lymphoma-2 inhibitor, is a promising novel drug that is currently used with hypomethylating agents (HMAs) like Azacitidine or Decitabine in older patients with acute myeloid leukemia (AML). These patients are known to have a high burden of cardiovascular (CV) risk factors and comorbidities.
The toxicity profile of Venetoclax includes neutropenia, gastrointestinal issues, and diarrhea, while there is growing concern regarding its potential cardiotoxicity in patients undergoing treatment for Acute Myeloid Leukemia. High doses or prolonged use of Venetoclax may lead to serious cardiac complications, such as myocardial infarction, new-onset atrial fibrillation, and even sudden cardiac death.
Traditionally, cardiotoxicity monitoring is conducted via serial measurements of Left Ventricular Ejection Fraction (LVEF) through standard echocardiography. However, LVEF is an insensitive and late indicator; a drop in LVEF occurs only after a significant loss of myocardial reserve has already taken place, often rendering the damage irreversible.Speckle Tracking Echocardiography (STE) is an advanced, non-invasive imaging modality that quantifies myocardial deformation by tracking acoustic markers (speckles) frame-by-frame. It measures Global Longitudinal Strain (GLS), which can detect subclinical cardiotoxicity (early micro-vascular and myofibrillar dysfunction) long before any detectable decline in conventional LVEF manifests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and / or Hypomethylating Agent based regimens * Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
Key inclusion criteria (3 listed)
- Age ≥16 years with newly diagnosed, histologically confirmed AML.Scheduled to receive either:- Cohort A (Intensive): Anthracycline-based induction - Cohort B (Non-Intensive): Venetoclax and / or Hypomethylating Agent based regimens
- Baseline LVEF ≥ 50% as measured by standard baseline echocardiography.
- Patient provided written, informed consent.
Key exclusion criteria (4 listed)
- Prior history of anthracycline or venetoclax_HMAs exposure.
- Pre-existing severe structural heart disease (e.g., severe valvular heart disease, ischemic cardiomyopathy, basal LVEF <50%).
- Persistent hemodynamically unstable arrhythmias.
- Poor acoustic windows making reliable 2D-STE tracking impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of cardiotoxcicity between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / or HMA regimens after four cycles of chemotherpy
Time frame: 2 years
.To evaluate and compare the incidence of subclinical cardiotoxicity (defined as a relative reduction in Left Ventricular GLS >15 % from baseline) between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / or HMA regimens after four cycles of chemotherpy by speckle tracking echocardiographic assesment which measure Global longitudinal strain also by ECG,High sensitive Troponin and CKMb
2 secondary outcomes
Evaluate and compare alteration in Left ventricular systolic function by conventional echocardiography between both therapeutic groups.
Time frame: 2 years
Assesment of Organ Dysfunction
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Acute Myeloid Leukemia (AML), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fawzy Hussein, Assistant Lecturer (+201153375657, mo.fa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cardiotoxcicity between newly diagnosed AML patients receiving anthracycline-based intensive induction and those receiving a Venetoclax and / or HMA regimens after four cycles of chemotherpy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.