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Second STOP After Pioglitazone Priming in CML Patients
Sponsor: Versailles Hospital
Summary
Single-center study, prospective, phase II trial. The study objectives are : * To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation. * To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain \< MR4.5 with the combination PIO and TKI administered for at least 6 months.
Official title: Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2016-12
Completion Date
2028-12
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Pioglitazone + TKI
Locations (6)
Centre Hospitalier de Versailles
Le Chesnay, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
CHU Lyon
Lyon, France
CHU de Nantes
Nantes, France
CHU de Rennes
Rennes, France
IUCT
Toulouse, France