Chronic Myeloid Leukemia (CML)Phase 2PIO2STOPNCT02889003
Second STOP After Pioglitazone Priming in CML Patients
A Phase 2 study testing Pioglitazone + TKI in people with Chronic Myeloid Leukemia (CML), run by Versailles Hospital at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia (CML)
- What is being tested?
- Pioglitazone + TKI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 6 sitesFrance
- Study dates
- Dec 2016to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 3 recruiting
- Recruiting
Centre Hospitalier de Versailles
Le Chesnay, 78150
Philippe rousselot, phrousselot@ght78sud.fr
- Withdrawn
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
- Recruiting
CHU Lyon
Lyon
Marie Balsat
- Withdrawn
CHU de Nantes
Nantes, 44093
- Withdrawn
CHU de Rennes
Rennes, 35033
- Recruiting
IUCT
Toulouse
Fran HUGUET
About this study
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
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.
- Conditions
- Chronic Myeloid Leukemia (CML)
- Being tested
- Pioglitazone + TKI
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone + TKIDrug
| Study group | Role | What they receive |
|---|---|---|
| CML patients following molecular response loss | Experimental | Not described Receives: Drug: Pioglitazone + TKI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 24 months after inclusion
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.
Measured: Up to 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia (CML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe ROUSSELOT, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889003
- Sponsor's protocol ID
- P16/05_PIO2STOP
- Acronym
- PIO2STOP
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2016
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889003
- Acronym / sponsor ID
- PIO2STOP / P16/05_PIO2STOP
- Conditions
- Chronic Myeloid Leukemia (CML)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CML patients following molecular response loss | Experimental | Drug: Pioglitazone + TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone + TKI | Drug | CML patients following molecular response loss |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 24 months after inclusion
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.
Time frame: Up to 24 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pioglitazone + TKI in people with Chronic Myeloid Leukemia (CML), run by Versailles Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Roux, MC (+33139239777, sroux@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Up to 24 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.