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Clinical Trial Summary

This phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. Researchers will describe response rates and adverse events.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05638763
Study type Interventional
Source Hospital Universitario Dr. Jose E. Gonzalez
Contact Fernando De la Garza Salazar, MD
Phone (52) 811 080 2131
Email fernandodelagarza@gmail.com
Status Recruiting
Phase Phase 2
Start date November 2024
Completion date November 2024

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