ClinicalTrials.gg
Not yet recruitingNCT06684509Updated Nov 12, 2024

Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

A Phase 1/2 interventional study of Atrovastain in Leukemia and Hodgkin Disease, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Assiut University · Phase 1/2, Interventional, and Prevention

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1/2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Leukemia with a site in Egypt — 3 open to participants now, 4 under way, 1 of them phase 3. Leukemia · Egypt.

Started
2024
the only one that year
Phase 1/2
2 of 12
1 open now
Registered
11th of 12
by date
Lead sponsor
2 of 12
Assiut University

Among the 12 studies in Leukemia with a site in Egypt, this one is the only one that started in 2024, is one of 2 in phase 1/2, and was the 11th registered.

Leukemia

2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.

Browse Leukemia studies →

Open to participants now

3 of the 12 studies in Leukemia with a site in Egypt are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Leukemia with a site in Egypt, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Leukemia
  • Hodgkin Disease

Keywords

  • Cardiotoxicity
  • Atrovastatin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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%

Exclusion criteria

Exclusion criteria:

Cardiac dysfunction with EF \< 60% Other hematologic Pregnant women and breastfeeding Patients refuse participate in research

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • No intervention
    Non Atrovastatin group

    control group of the same condition they will not tkae atrovastatin

  • Experimental
    Atrovastatin group

    patients will receive atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

    Drug: Atrovastain

Interventions

  • DrugAtrovastain

    atorvaststin 40mg/daily , started before anthracyclin treatment and continued 12 months

06

What researchers measure

Primary outcomes

  1. Cardiotoxicity

    Effect of atorvaststin for anthracyclin induced cardiotoxicity measured through Echo and ECG

    Time frame: 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

    Time frame: along 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Sep 2027, 34 months later.

Of 45 non-industry phase 1/2 interventional studies under Leukemia, half reached primary completion within 76 months of starting (the median), counting those still running; a quarter within 58 and three quarters within 95. This study's planned 34 months is below that.

Counting every sponsor, half of 77 studies reached it within 79 months; a quarter within 55 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2024
First posted
Nov 12, 2024
StartEst.
Nov 2024
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2029
Last update
Nov 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06684509
Lead sponsor
Assiut University
Responsible party
Esraa Mahmoud Abd Rabou (Physician, Assiut University) — Principal investigator
First posted
Nov 12, 2024
Start date
Nov 2024 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2029 (estimated)
Last update
Nov 12, 2024

Study contacts

Esraa AbdRabou, Bacheolar of medicine
Contact
mahmoudisraa01@gmail.com
+201151477447

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion