drugset / Trial / NCT02889003

Second STOP After Pioglitazone Priming in CML Patients

NCT02889003

Phase 2 Recruiting 26 enrolled Versailles Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-12
Primary completion
2027-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pioglitazone Small molecule