Last updated 2 years ago

Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia

15 patients around the world
Available in Mexico
Dasatinib is a second-generation tyrosine kinase inhibitor that is metabolized by the cytochrome P450. Dasatinib has shown efficacy in patients with chronic myelogenous leukemia. Standard-dose dasatinib is 50mg-140mg/day orally, continuously. However, when combined with a strong CYP3A4 inhibitor, a dose reduction of 75% is warranted. This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce the dosage and costs of dasatinib for adults with chronic myelogenous leukemia. Researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months and adverse events (i.e., pleural effusion) associated with this strategy.
Hospital Universitario Dr. Jose E. Gonzalez
1Research sites
15Patients around the world

This study is for people with

Leukemia
Chronic myeloid leukemia

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Age >18 years
Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016
Eastern Cooperative Oncology Group (ECOG) 0-2
Chronic heart disease (NYHA III-IV)
Bleeding disorders not attributed to the hematological malignancy
Pregnancy
Lactation
Chronic myeloid leukemia in blast phase
Organic dysfunction (Marshall score ≥2)

Sites

Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Recruiting
Av. Madero y Gonzalitos S/N, Mitras Centro, Monterrey, Nuevo León
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