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

Mansoura University

Status and phase: Not yet enrolling; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Standard care +itraconazole 200mg; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07069933

2024-42-2024-120

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Control arm

Other group

Description:

Standard Care

Treatment:

Drug: Chemotherapy

Interventional arm

Active Comparator group

Description:

Standard Care plus itraconazole

Treatment:

Drug: Standard care +itraconazole 200mg