Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?

NCT ID: NCT07069933

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control arm

Standard Care

Group Type OTHER

Chemotherapy

Intervention Type DRUG

Standard Care (in control arm)

Interventional arm

Standard Care plus itraconazole

Group Type ACTIVE_COMPARATOR

Standard care +itraconazole 200mg

Intervention Type DRUG

Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals.

Interventions

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Standard care +itraconazole 200mg

Is an antifungal used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals.

Intervention Type DRUG

Chemotherapy

Standard Care (in control arm)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with Acute Myeloid leukemia, and aged 18 years or older
2. Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols

Exclusion Criteria

1. Patients with any other types of malignancies rather than Leukemia and patients.
2. Patients with history alcohol intake, acute or chronic.
3. Patients with documented hypersensitivity or allergy to Itraconazole.
4. Patients suffer from chronic heart failure
5. Patients present with severe dehydration.
6. Patients with severe kidney dysfunction
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha Mansour

Lecturer of Clinical Pharmacy and Pharmacy Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed el-Husseiny shams

Role: PRINCIPAL_INVESTIGATOR

Professor Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University

Moetaza Mahmoud Hassab Soliman

Role: STUDY_DIRECTOR

Associate professor of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

Noha Osama Mansour Mansour

Role: STUDY_DIRECTOR

Lecturer of Clinical Pharmacy, Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University

Sara Mohamed Ali Atwa

Role: STUDY_DIRECTOR

Lecturer of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Mansoura University

Locations

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Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura,

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Gayda A.R. Abuhammad, MSc

Role: CONTACT

+962798241327

Other Identifiers

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2024-42-2024-120

Identifier Type: -

Identifier Source: org_study_id

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