Tests pioglitazone with leukemia drugs in people with chronic myeloid leukemia
Tests pioglitazone with leukemia drugs in adults with chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Second STOP After Pioglitazone Priming in CML Patients
Key facts
- Where
- Le Chesnay, Le Kremlin-Bicêtre, Lyon, Nantes, Rennes, and Toulouse, FranceSee the 6 sites
- Phase
- Phase 2
Where in France
- Centre Hospitalier de VersaillesLe Chesnay, FranceTaking people
- Hopital BicetreLe Kremlin-Bicêtre, FranceNo longer taking part
- Chu LyonLyon, FranceTaking people
- CHU de NantesNantes, FranceNo longer taking part
- CHU de RennesRennes, FranceNo longer taking part
- IUCTToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Versailles Hospital
- Trial code
- NCT02889003
- Record updated
- 6 July 2026
- Original description
Single-center study, prospective, phase II trial.Read full original descriptionShow less
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
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.
Inclusion: CML in any phase. patient in MR4; Loss of MMR following a first or subsequent TKI discontinuation trial; Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib; Age >18 years; Serum bilirubin <1.5 x upper limit of normal values; AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values; Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence; Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period; Signed informed consent; Be able and willing to comply with study visits and procedures.
Exclusion: Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment; Prior allogeneic hematopoietic stem cell transplantation; Patient requiring anti-diabetic medications to manage hyperglycemia; Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria); Use of TZD within 28 days prior to enrollment; Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment; Hepatic insufficiency; History of bladder cancer; Known history of macular edema; Known history of ABL1-domain mutation associated with resistance to the discontinued TKI; Known allergy to PIO; Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug; Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1; Loss of CHR; Diagnosed hematuria; Pregnant or breastfeeding; Uncontrolled peripheral edema (2+ or more) of any etiology.