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

NCT07069933 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-42-2024-120
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of blasts in bone marrow at d21 after induction

  8 weeks

Study Arms (2)

Control arm

OTHER

Standard Care

Drug: Chemotherapy

Interventional arm

ACTIVE COMPARATOR

Standard Care plus itraconazole

Drug: Standard care +itraconazole 200mg

Interventions

Standard care +itraconazole 200mg DRUG

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

Interventional arm

Chemotherapy DRUG

Standard Care (in control arm)

Control arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

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

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mohamed el-Husseiny shams

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

  PRINCIPAL INVESTIGATOR

• Moetaza Mahmoud Hassab Soliman

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

  STUDY DIRECTOR

• Noha Osama Mansour Mansour

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

  STUDY DIRECTOR

• Sara Mohamed Ali Atwa

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

  STUDY DIRECTOR

Central Study Contacts

Gayda A.R. Abuhammad, MSc

CONTACT

+962798241327; gaydaabuhammad1997@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy and Pharmacy Practice

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

EG (1)