LeukemiaPhase 1/2NCT06684509
Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia
A Phase 1/2 study testing Atrovastain in people with Leukemia and Hodgkin Disease, run by Assiut University at 1 site in Egypt.
Trial summary
The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Hodgkin Disease
- What is being tested?
- Atrovastain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2024to Sep 2029
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%
Who cannot join
- Cardiac dysfunction with EF < 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut, 71515
Assiut university, 088-2354130, complaints@aun.edu.eg
About this study
Official title: Using of Atorvastatin for Anthracyclin _ Associated Cardiotoxicity in Hemetological Malignancies Patients.
The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL).
The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.
Read more
The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.
The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.
- Conditions
- Leukemia, Hodgkin Disease
- Being tested
- Atrovastain
- Keywords
- Cardiotoxicity, Atrovastatin
- Medical subject headings
- Leukemia, Hodgkin Disease, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtrovastainDrug
atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months
| Study group | Role | What they receive |
|---|---|---|
| Non Atrovastatin group | No intervention | control group of the same condition they will not tkae atrovastatin |
| Atrovastatin group | Experimental | patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months Receives: Drug: Atrovastain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity
Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG
Measured: During the study period along 12 months
Secondary outcomes (1)
Cardiotoxicity events correlation to high risk patients
we will correlate cardiotoxicity with the factors that make those patients high risk group for cardiotoxicity
Measured: along 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mahmoud Abd Rabou, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684509
- Sponsor's protocol ID
- Atorvaststin and cardiotoxicit
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using of Atorvastatin for Anthracyclin _ Associated Cardiotoxicity in Hemetological Malignancies Patients.
- ClinicalTrials.gov ID
- NCT06684509
- Acronym / sponsor ID
- Atorvaststin and cardiotoxicit
- Conditions
- Leukemia, Hodgkin Disease
- Keywords
- Cardiotoxicity, Atrovastatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Nov 2024 (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 research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL).
The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.
The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.
The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Atrovastatin group | No intervention | –control group of the same condition they will not tkae atrovastatin |
| Atrovastatin group | Experimental | Drug: Atrovastainpatients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%
Key exclusion criteria (1 listed)
- Cardiac dysfunction with EF < 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrovastainatorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months | Drug | Atrovastatin group |
Primary outcome
Cardiotoxicity
Time frame: During the study period along 12 months
Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG
1 secondary outcome
Cardiotoxicity events correlation to high risk patients
Time frame: along 12 months
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 12 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atrovastain in people with Leukemia and Hodgkin Disease, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Esraa AbdRabou, Bacheolar of medicine (+201151477447, mahmoudisraa01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiotoxicity (time frame: During the study period along 12 months). 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 12 Nov 2024.