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Not yet recruiting NCT07069933

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

Phase II Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard care +itraconazole 200mg, Chemotherapy.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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?"

Overview

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.

Interventions

  • Drug 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.
  • Drug Chemotherapy
    Standard Care (in control arm)

Primary outcome measures

  • Percentage of blasts in bone marrow at d21 after induction [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, Mansoura, — Al Mansurah

Identifiers

NCT: NCT07069933 · 2024-42-2024-120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗