NCT02889003RecruitingPhase 2
Second STOP After Pioglitazone Priming in CML Patients
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 19 Aug 2016
- Start date
- 1 Dec 2016
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Versailles Hospital
- Diseases
- Chronic myeloid leukaemia
- NCT number
- NCT02889003
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- From 1 Dec 2016 to the primary completion date, 31 Dec 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de Versailles Coordinator of this site? Confirm its status | Le Chesnay | France | Recruiting |
| Hopital Bicetre Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Withdrawn |
| Chu Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Withdrawn |
| CHU de Rennes Coordinator of this site? Confirm its status | Rennes | France | Withdrawn |
| IUCT Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.