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