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NCT Number: NCT07069933

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Chemotherapy

Drug

Standard Care (in control arm)

Primary outcomes

  1. Percentage of blasts in bone marrow at d21 after induction

    Time frame: 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Gayda A.R. Abuhammad, MSc

CONTACT

[email protected]

+962798241327

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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