Acute Myeloid LeukemiaPhase 2NCT07069933
Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?
A Phase 2 study testing Chemotherapy in people with Acute Myeloid Leukemia, run by Mansoura University at 1 site in Egypt.
Trial summary
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2025to Dec 2025
- Phase
- Phase 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Acute Myeloid leukemia, and aged 18 years or older
- Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols
Who cannot join
- Patients with any other types of malignancies rather than Leukemia and patients.
- Patients with history alcohol intake, acute or chronic.
- Patients with documented hypersensitivity or allergy to Itraconazole.
- Patients suffer from chronic heart failure
- Patients present with severe dehydration.
- Patients with severe kidney dysfunction
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
Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura,
Al Mansurah
About this study
Official title: "Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?"
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Standard care +itraconazole 200mg, Chemotherapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care +itraconazole 200mgDrug
Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals.
ChemotherapyDrug
Standard Care (in control arm)
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Standard Care Receives: Drug: Chemotherapy |
| Interventional arm | Active comparator | Standard Care plus itraconazole Receives: Drug: Standard care +itraconazole 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of blasts in bone marrow at d21 after induction
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Mansoura 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Mohamed el-Husseiny shams, Principal investigator, Professor Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura UniversityMoetaza Mahmoud Hassab Soliman, Study director, Associate professor of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura UniversityNoha Osama Mansour Mansour, Study director, Lecturer of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura UniversitySara Mohamed Ali Atwa, Study director, Lecturer of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069933
- Sponsor's protocol ID
- 2024-42-2024-120
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?"
- ClinicalTrials.gov ID
- NCT07069933
- Acronym / sponsor ID
- 2024-42-2024-120
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jul 2025 (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.
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Drug: ChemotherapyStandard Care |
| Interventional arm | Active comparator | Drug: Standard care +itraconazole 200mgStandard Care plus itraconazole |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Acute Myeloid leukemia, and aged 18 years or older
- Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols
Key exclusion criteria (6 listed)
- Patients with any other types of malignancies rather than Leukemia and patients.
- Patients with history alcohol intake, acute or chronic.
- Patients with documented hypersensitivity or allergy to Itraconazole.
- Patients suffer from chronic heart failure
- Patients present with severe dehydration.
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 |
|---|---|---|
| Standard care +itraconazole 200mgIs an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. | Drug | Interventional arm |
| ChemotherapyStandard Care (in control arm) | Drug | Control arm |
Primary outcome
Percentage of blasts in bone marrow at d21 after induction
Time frame: 8 weeks
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 17 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leukemia
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A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Mohamed el-Husseiny shams principal investigator
Professor Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
Moetaza Mahmoud Hassab Soliman study director
Associate professor of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
Noha Osama Mansour Mansour study director
Lecturer of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy in people with Acute Myeloid Leukemia, run by Mansoura 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 2 inclusion and 6 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 17 Jul 2025. 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 phase mean?
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 Gayda A.R. Abuhammad, MSc (+962798241327, gaydaabuhammad1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of blasts in bone marrow at d21 after induction (time frame: 8 weeks). 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 17 Jul 2025.