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

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Collaborator: Fernando De la Garza Salazar
• Treatments: Dasatinib; Ketoconazole

Criteria

Inclusion Criteria:

1. Age >18 years

2. Chronic myeloid leukemia in chronic phase according to the World Health Organization 2016

3. Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

1. Chronic heart disease (NYHA III-IV)

2. Bleeding disorders not attributed to the hematological malignancy

3. Pregnancy

4. Lactation

5. Chronic myeloid leukemia in blast phase

6. Organic dysfunction (Marshall score ≥2)