Pioglitazone and TKI [USA]

What is the purpose of the study

This is a study to find out if pioglitazone hydrochloride enhances the activity of tyrosine kinase inhibitor therapy in patients with CML that has come back after a first TKI discontinuation. The success of the combination is measured by the rate of successful second discontinuation of TKI. Pioglitazone hydrochloride is a drug approved in the USA to treat diabetes and has been shown in laboratory studies to increase CML stem cell death when given together with TKI therapy.

Patients receive pioglitazone hydrochloride by mouth once daily on days 1-28. Patients also start or continue the same TKI therapy as before stopping. Courses repeat every 28 days for 6 months unless the disease progresses or unacceptable side effects occur.

Key inclusion criteria

This study includes patients 16 years and older with chronic myeloid leukemia (CML) in any phase. Patients are eligible for inclusion if they have lost major molecular response (MMR) after a first tyrosine kinase inhibitor (TKI) stop trial.

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Emory University/Winship Cancer Institute
Vamsi Kota, MD
Georgia, 30322
United States