Second STOP After Pioglitazone Priming in CML Patients

Recruiting now · Phase 2

Conditions studied: Chronic Myeloid Leukemia (CML)

In brief

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.

Key facts

Study ID

NCT02889003

Run by

Versailles Hospital

People needed

26

Starts

2016-12-01

Expected to finish

2028-12-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1.
• Loss of CHR.
• 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.
• 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.
• Diagnosed hematuria.
• Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)
• Known history of macular edema.
• Known history of ABL1-domain mutation associated with resistance to the discontinued TKI.
• Known allergy to PIO.
• Pregnant or breastfeeding.
• Use of TZD within 28 days prior to enrollment.
• Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug.
• Uncontrolled peripheral edema (2+ or more) of any etiology

Where it is running

• Centre Hospitalier de Versailles — Le Chesnay, France (enrolling)
• CHU Lyon — Lyon, France (enrolling)
• IUCT — Toulouse, France (enrolling)
• Hôpital Bicêtre — Le Kremlin-Bicêtre, France
• CHU de Nantes — Nantes, France
• CHU de Rennes — Rennes, France

Full record on ClinicalTrials.gov

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