CML ADVOCATES NETWORK

Clinical Trials

HE22-00031 = Cytochrome P450 Inhibition to Decrease Dosage of Dasatinib for Chronic Myelogenous Leukemia [Mexico]

Study title

Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia

Scientific title

Cytochrome P450 Inhibition With Ketoconazole to Decrease Dosage and Costs of Dasatinib for Chronic Myelogenous Leukemia

Type of study

Treatment optimization trial

Phase

2

Current status

Recruiting

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Other trial ID

ClinicalTrials.gov NCT05638763

What is the purpose of the study

The aim of this study is to show efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia (CML).

What will happen during the study

Patients will receive dasatinib 25 mg by mouth daily for one year and ketoconazole 200 mg by mouth twice a day for one year.

Researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months, and adverse events observed with this treatment strategy.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older.
  • have chronic myeloid leukemia in chronic phase (CML-CP) according to the World Health Organization criteria 2016.
  • have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have chronic heart disease (NYHA III-IV).
  • have bleeding disorders not attributed to the hematological malignancy.
  • are pregnant or breast-feeding.
  • have chronic myeloid leukemia in blast phase.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

November 2024

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Hospital Universitario Dr. Jose E. Gonzalez
in collaboration with
Fernando De la Garza Salazar

Scientific lead / contact

Contact:
Fernando De la Garza Salazar, MD

Principal investigator

Fernando De la Garza Salazar, MD

Study centers / principal investigators

Mexico

Hospital Universitario
Dr. José Eleuterio González
Monterrey, Nuevo Leon, 64630